Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)
Phase: NA
Conditions: Arrhythmia
Sponsor: Boston Scientific Corporation

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Medical Device Clinical Trial Protocol 
 
Reference Number：C2082 
 
Protocol Title：Observation of ImageReady™ MR Conditional Defibrillation System in 
China (MR ICD) 
 
Investigational Device：ImageReady™ MR Conditional Defibrillation System 
 
Device Model：Pulse Generator     D150 et. al. 
Defibrillation Lead  0692 et. al. 
              LV Lead          4671 et. al. 
 
Class of device： 
 
    Class 3 medical device requiring clinical trials  Yes□  No☒ 
    Same class device within China  Yes□  No☒ 
 
Protocol version and date： Rev/AC，2018, Mar 1  
 
Clinical trial sites： Zhongshan Hospital Fudan University et. al. 
 
Pricipal Investigator： Su Yangang 
 
Sponsor：BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC China”) 
 
Agent：not applicable 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 

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Observation of ImageReady™ MR Conditional Defibrillation 
System in China  
(MR ICD) 
 
 
CLINICAL PROTOCOL 
 
Study Reference Number：C2082 
 
Sponsored By 
BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC China”) 
Part A, 2nd Floor, No.68, Rijing Road, 
Free Trade Zone, 
Shanghai, China 200131 
 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 

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Contact Information 
Role 
Contact 
Clinical Contact 
Peng, Lv  
Clinical Trial Manager 
BSC China 
12th Floor, Building 2, The World Profit Center 
16, Tianze Road, Chaoyang District 
Beijing 100125, P.R.China 
Email：Peng.Lv@bsci.com 
Cell：+86 18516830968 
Tele：+86 10 85216439 
Coordinating 
Principal 
Investigator 
Prof. Su, Yangang 
Zhongshan Hospital Fudan University 
No.180, Fenglin Road, Xuhui District 
Shanghai 200032, P.R. China 
Study Site List 
See “MR ICD site list and contact information” 
 
 
Original Release: May 11, 2017 
Current Version: Mar 1, 2018 
 
Revision History 
Revision 
Number 
Release 
Date 
Template 
number and 
version 
Section 
Change 
Reason for 
Change 
AA 
May 11, 
2017 
90702637 
Rev./Ver. 
AH 
N/A 
N/A  
Initial 
release 
AB 
Jul 24, 
2017 
90702637 
Rev./Ver. 
AH 
Whole 
document 
Delete requirement for magnet 
and LV lead delivery system, 
and related description and 
assessment. 
Regulatory 
requirement. 
AB 
Jul 24, 
2017 
90702637 
Rev./Ver. 
AH 
Whole 
document 
Delete non-Gore coating leads. 
Regulatory 
requirement. 
AB 
Jul 24, 
2017 
90702637 
Rev./Ver. 
Whole 
document 
Delete the assessment of Beeper 
function. 
Regulatory 
and trial 

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Revision 
Number 
Release 
Date 
Template 
number and 
version 
Section 
Change 
Reason for 
Change 
AH 
management 
requests. 
AB 
Jul 24, 
2017 
90702637 
Rev./Ver. 
AH 
Table 12-3 
Parameters for RV shock 
impedance tests added. 
Protocol 
refinement 
AC 
Mar 1, 
2018 
90702637 
Rev./Ver. 
AI 
Contact 
Information 
author information deleted 
Based on 
protocol 
template 
AC 
Mar 1, 
2018 
90702637 
Rev./Ver. 
AI 
5.1, 6.1, 10.3, 
12, 20.3 
Descriptions regarding no 
pacing function during MRI 
protection mode deleted, and 
description on asynchronization 
pacing added. 
Item 4 and 5 from exclusion 
criteria dropped. 
Requirement for 12 lead ECG 
and 10s ECG episode cancelled. 
Sections for subject evaluation 
before MRI and MRI visit 
updated.  
The function 
of pacing 
under MRI 
protection 
mode was 
added for 
the device. 
AC 
Mar 1, 
2018 
90702637 
Rev./Ver. 
AI 
12.7.1.1 
Lift the requirement for 
magnet origin. 
Based on 
magnet 
availability 
in hospitals 
AC 
Mar 1, 
2018 
90702637 
Rev./Ver. 
AI 
12.1, 12.4 
Add: A pregnancy test must be 
performed within 7 days prior 
to the index procedure in 
women of child-bearing 
potential 
Trial 
management 
request 
 
 

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2. Protocol Synopsis 
Observation of ImageReady™ MR Conditional Defibrillation System in 
China (MR ICD) 
Study 
Objectives 
To observe the safety and effectiveness of ImageReady™ MR conditional 
defibrillation system in a Chinese population. 
Test Device 
ImageReadyTM MR Conditional Defibrillation System 
Device Type 
Pulse Generator 
DYNAGEN ICD 
D150, D152 
DYNAGEN CRT-D 
G158 
INOGEN ICD 
D140, D142 
INOGEN CRT-D 
G148 
 
Defibrillation Lead (active fixation) 
RELIANCE 4-FRONT 
(single coil, Gorecoating) 
0692, 0693, 0657 
RELIANCE 4-FRONT 
(dual coil, Gore coating) 
0695, 0696, 0658 
 
LV Lead 
ACUITY X4 (straight) 
4671, 4672 
ACUITY X4 (spiral) 
4674, 4675, 4677, 4678 
 
DYNAGEN series pulse generators will be used in this study, including 
10 ICDs (with at least 2 single chamber and 2 dual chamber ICDs) and 10 
CRT-Ds.  
Lead selection will be mainly decided according to clinical requirement. 
Study Design 
Multi-center, prospective, single –arm study 
Planned 
Number of 
Subjects 
20 
Planned 
approximately 5 investigational sites from China 

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Observation of ImageReady™ MR Conditional Defibrillation System in 
China (MR ICD) 
Number of 
Investigational 
Sites 
Primary Safety 
Endpoint 
MR scan-related Complication-free rate between the MR Scan and the 
MRI + 1 Month Visit 
Primary 
Effectiveness 
Endpoints 
1. Abnormal increase in RV shocking impedance from the pre-MR scan 
to the 1 Month post-MR scan 
2. Increase in RV pacing threshold from the pre-MR scan to the 1 
Month post-MR scan 
3. Decrease in RV sensed amplitude from the pre-MR scan to the 1 
Month post-MR scan 
4. Increase in LV pacing threshold from the pre-MR scan to the 1 
Month post-MR scan 
5. Decrease in LV sensed amplitude from the pre-MR scan to the 1 
Month post- MR scan 
Ancillary 
Assessments 
1. Assessment of RV and LV impedances 
2. Assessment of RA lead measurements 
3. Assessment of VT/VF episodes post-MR-scan 
4. Assessment of programming the MRI Protection Mode 
5. Assessment of Image Artifacts for non-medically necessary MR 
scans. 
Follow-up 
Schedule 
Phase I is completed when all the subjects finish MRI + 1 Month Visit, 
which starts Phase II till 1 year post implantation. 
- 
Screening and Enrollment Visit (≤ 30 days prior to implant 
procedure ) 
- 
Implant Procedure 
- 
Pre-Discharge Clinic Visit (3 – 72 hours post-implant) 
- 
MRI Visit (6-9 weeks post-implant) 

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Observation of ImageReady™ MR Conditional Defibrillation System in 
China (MR ICD) 
- 
MRI + 1 Month Visit (30 ± 7 days post-MRI Visit) 
- 
Every Three-month follow-ups post MR scan (±14 days, 
recommended) 
- 
One Year Visit (365±45 days post-implant) 
Study Duration 
Phase I is expected to last about 9 months after first subject enrollment, 
by when all the subjects will have finished MRI +1 Month Visit. 
Phase II continues to all the subjects complete one year follow-up 
post-implant, and the whole study is expected to last about 20 months 
after first subject enrollment. 
Key Inclusion 
Criteria 
1. Subject is indicated to Class I/II indications per guidelines/consensus 
released by Chinese Society of Cardiac Pacing and 
Electrophysiology 
2. Subject must have the ImageReady System as their initial (de novo) 
defibrillation system implant 
3. Subject will receive an ICD or CRT-D pulse generator in the left or 
right pectoral region ICD 
4. Subject is able and willing to undergo an MR scan 
5. 
Subject is willing and capable of providing informed consent and 
participating in all testing/ visits associated with this clinical study at 
an approved clinical study center and at the intervals defined by this 
protocol 
6. 
Subject is age 18 or above 
Key Exclusion 
Criteria 
1. Subject has other active or abandoned implanted cardiac rhythm 
devices, components or accessories present such as pulse generators, 
leads, lead adaptors or extenders  
2. Presence of metallic objects that represent a contraindication to MR 
imaging at the discretion of the Radiologist and impacting the ability 
to conduct the study protocol  
3. Subject needs or will need a medically necessary MR scan, before 
completing the 1-month post-MR follow-up visit 
4. Subject is not clinically capable of tolerating the absence of 
Tachycardia therapy support for the duration that the pulse generator 
is in MRI Protection Mode, per Physician discretion 

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Observation of ImageReady™ MR Conditional Defibrillation System in 
China (MR ICD) 
5. Subjects currently requiring dialysis 
6. Subject has a mechanical heart valve 
7. Subject has a known or suspected sensitivity to dexamethasone 
acetate (DXA) 
8. Subject is currently on the active heart transplant list 
9. Subject has documented life expectancy of less than 12 months 
10. Subject is enrolled in any other concurrent study that might interfere 
with this study 
11. Women of childbearing potential who are or might be pregnant at the 
time of this study 
Statistical Methods 
Primary 
Statistical 
Hypothesis 
This study is a single-arm, small sample clinical study without any 
hypothesis testing. 
It can be considered reasonable if up to 2 failed cases of primary safety 
endpoint event occur. 
It can be considered reasonable if up to 2 failed cases of endpoint event 
occur in each of the five primary effectiveness endpoints. 
Statistical Test 
Method 
Descriptive statistics will be conducted for the endpoint events. 
Sample Size 
Parameters 
This study is a single-arm, small sample clinical study without any 
hypothesis testing. Twenty subjects (10 with ICD and 10 with CRT-D) 
will be enrolled. It is assumed that the attrition should not be more than 2 
cases in each group, so that at least 8 subjects shall be included in the 
final analysis for each group. 
 
 

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3. Table of Contents 
1. 
TITLE PAGE ......................................................................................................................... 1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 5 
3. 
TABLE OF CONTENTS .......................................................................................................... 9 
 Figure ...................................................................................................................... 13 
 Table ........................................................................................................................ 13 
4. 
INTRODUCTION ................................................................................................................. 14 
5. 
DEVICE DECRIPTION ......................................................................................................... 15 
 MRI Protection Mode ............................................................................................ 16 
 MRI Protection Mode Time-out Function ........................................................... 18 
 Beeper Feature ....................................................................................................... 18 
6. 
CONDITIONS OF USE ......................................................................................................... 18 
 Cardiology ............................................................................................................... 18 
 Radiology ................................................................................................................ 19 
7. 
OBJECTIVES ...................................................................................................................... 20 
8. 
ENDPOINTS ........................................................................................................................ 20 
 Primary Safety Endpoint ....................................................................................... 20 
 Primary Effectiveness Endpoints.......................................................................... 20 
 Ancillary Assessments ............................................................................................ 20 
9. 
DESIGN .............................................................................................................................. 21 
 Scale and Duration ................................................................................................. 21 
 Justification for the Study Design ......................................................................... 22 
10. SUBJECT SELECTION ......................................................................................................... 23 
 Study Population and Eligibility ........................................................................... 23 
 Inclusion Criteria ................................................................................................... 23 
 Exclusion Criteria .................................................................................................. 23 

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11. SUBJECT ACCOUNTABILITY .............................................................................................. 24 
 Enrollment .............................................................................................................. 24 
 Withdrawal ............................................................................................................. 24 
 Subject Status and Classification .......................................................................... 25 
 Enrollment Controls .............................................................................................. 26 
 End-of-Study Action Plan ..................................................................................... 26 
12. STUDY METHODS .............................................................................................................. 26 
 Data Collection ....................................................................................................... 26 
 Study Candidate Screening ................................................................................... 26 
 Informed Consent .................................................................................................. 26 
 Enrollment Visit ..................................................................................................... 27 
 Implant .................................................................................................................... 29 
 Pre-Discharge ......................................................................................................... 33 
 MRI Visit ................................................................................................................ 34 
 MRI + 1 Month Visit .............................................................................................. 42 
 Every Three-month Follow ups through Three Years (Recommended) .......... 43 
 Implant + 1Year Visit ........................................................................................... 44 
 Additional Visits.................................................................................................... 46 
 Medically Necessary MRI Visits .......................................................................... 48 
 Study Completion ................................................................................................. 49 
13. STATISTICAL CONSIDERATIONS ....................................................................................... 50 
 Primary Endpoints ................................................................................................. 50 
 Ancillary Assessments ............................................................................................ 54 
 Sample Size ............................................................................................................. 55 
 General Statistical Methods .................................................................................. 55 
14. DATA MANAGEMENT ........................................................................................................ 56 
 Data Collection, Processing, and Review ............................................................. 56 
 Data Retention ........................................................................................................ 57 
15. AMENDMENTS ................................................................................................................... 57 

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16. DEVIATIONS ...................................................................................................................... 58 
17. DEVICE ACCOUNTABILITY ............................................................................................... 59 
18. COMPLIANCE ..................................................................................................................... 60 
 Statement of Compliance ....................................................................................... 60 
 Investigator Responsibilities ................................................................................. 60 
 Ethics Committee ................................................................................................... 63 
 Sponsor Responsibilities ........................................................................................ 63 
 Insurance ................................................................................................................. 65 
19. MONITORING ..................................................................................................................... 66 
20. POTENTIAL RISKS AND BENEFITS .................................................................................... 67 
 Anticipated Adverse Events .................................................................................. 67 
 Risks Associated with Study Devices .................................................................... 68 
 Risks Associated with Participation in the Clinical Study ................................. 68 
 Risk Minimization Actions .................................................................................... 70 
 Anticipated Benefits ............................................................................................... 70 
 Risk to Benefit Rationale ....................................................................................... 71 
21. SAFETY REPORTING .......................................................................................................... 71 
 Reportable Events by investigational site to Boston Scientific .......................... 71 
 Definitions and Classification ............................................................................... 72 
 Relationship to Study Devices ............................................................................... 74 
 Investigator Reporting Requirements .................................................................. 76 
 Boston Scientific Device Deficiencies .................................................................... 77 
 Reporting to Regulatory Authorities / ECs / Investigators ................................ 78 
 Subject Death reporting ....................................................................................... 79 
22. INFORMED CONSENT......................................................................................................... 80 
23. COMMITTEES .................................................................................................................... 82 
 Safety Monitoring Process ..................................................................................... 82 
 Clinical Events Committee .................................................................................... 82 
24. SUSPENSION OR TERMINATION ........................................................................................ 83 

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 Premature Termination of the Study ................................................................... 83 
 Criteria for Premature Termination of the Study .............................................. 83 
 Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval ................................................................................................................. 83 
 Requirements for Documentation and Subject Follow-up ................................. 84 
 Criteria for Suspending/Terminating a Study Site ............................................. 84 
25. PUBLICATION POLICY ....................................................................................................... 85 
26. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................. 85 
 Subject Reimbursement......................................................................................... 85 
 Compensation for Subject’s Health Injury ......................................................... 86 
27. BIBLIOGRAPHY .................................................................................................................. 86 
28. ABBREVIATIONS ................................................................................................................ 86 
29. MR SCAN SEQUENCES PROTOCOL ................................................................................... 87 
 Background ............................................................................................................. 87 
 Conditional Labeling ............................................................................................. 88 
 Notes Regarding the MR Scan .............................................................................. 88 
 
 
 

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 Figure 
Figure 9-1 MR ICD study Design ........................................................................................... 22 
 
 Table 
Table 5-1 ImageReady MR Conditional Defibrillation System Components ........................ 15 
Table 12-1 Data Collection Schedule ..................................................................................... 28 
Table 12-2 Enrollment Source Documentation Requirements ............................................... 29 
Table 12-3 Test Parameters .................................................................................................... 29 
Table 12-4 Implant Source Documentation Requirements ..................................................... 33 
Table 12-5 Pre-Discharge Source Documentation Requirements .......................................... 34 
Table 12-6 MRI Visit Source Documentation Requirements ................................................. 40 
Table 12-7 MRI + 1 Month Source Documentation Requirements ........................................ 43 
Table 12-8 Every Three Month Source Documentation Requirements .................................. 44 
Table 12-9 Implant + 1Year Source Documentation Requirements ....................................... 45 
Table 12-10 Additional Follow-up Source Documentation Requirements ............................ 47 
Table 12-11 Medically Necessary MRI Visit Source Documentation Requirements ............ 48 
Table 20-1 Potential Adverse Events for Pulse Generator and/ or Lead System Implants .... 67 
Table 21-1 Safety Definitions ................................................................................................. 72 
Table 21-2 Criteria for Assessing Relationship of Study Device or Procedure to Adverse Event
 ............................................................................................................................. 75 
Table 21-3 Investigator Reporting Requirements ................................................................... 76 
Table 28-1 Abbreviations ....................................................................................................... 86 
Table 29-1 Scan Sequence Protocol ....................................................................................... 89 
 
 
 

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4. Introduction 
Magnetic resonance imaging (MRI) is a diagnostic technique that images body parts by 
producing a static magnetic field followed by rapidly changing radiofrequency fields to 
excite hydrogen nuclei. MRI scanning is now the imaging modality of choice for many 
neurological and musculoskeletal conditions. In the past, implanted cardiac devices including 
pacemakers and implanted cardioverter-defibrillators (ICD) have been contraindicated in 
MRI scanners. The potential adverse effects of MRI on defibrillation system include loss of 
capture due to lead tip heating and cardiac arrhythmias induced by unexpected pacing. 
A number of studies have reported on the relative safety of scanning patients with non-MR 
conditional cardiac pacemakers or implantable cardioverter-defibrillators. Nazarian et. al.1 
reported on 438 patients (54% with pacemakers and 46% with ICDs) undergoing 555 scans 
(18% involving thorax). In 3 patients, the device reverted to a transient back-up 
programming mode without long-term effects. The observed changes in sensing, impedance 
and pacing threshold did not require device revision or reprogramming. Recently, the result 
of MagnaSafe registry was published.2 Patients in the registry were referred for clinically 
indicated nonthoracic (75% with brain or spinal cord) MRI at a field strength of 1.5 T (1000 
pacemaker and 500 ICD scans). No deaths, lead failures, losses of capture, or ventricular 
arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI; 
the device had not been appropriately programmed per protocol before the MRI. The ratio of 
pacing threshold increase≥0.5V, P-wave amplitude decrease ≥50% and R-wave amplitude 
decrease ≥50% immediately after scan in ICD group was 0.8%, 0.3%, and 0.2%, respectively; 
and the long-term ratio was 0.3%, 0, 0. 
Presently some ICD manufactures are developing and producing MR conditional 
defibrillation systems. DYNAGEN and INOGEN, the new generation of defibrillation 
system series from Boston Scientific (BSC) were designed to be MR conditional.  
DYNAGEN and INOGEN defibrillation system series products (pulse generators and leads) 
have already been approved in China without MR conditional label. BSC China intends to 
expand the indication with additional MR conditional label, and name the defibrillation 
system as ImageReady™ MR conditional defibrillation system. 

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BSC is conducting a global multi-center study, ENABLE MRI (NCT02652481), on MR 
conditional systems including DYNAGEN and INOGEN. The study will enroll 500 subjects, 
to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation 
System when used in the 1.5T MRI environment under the labeled Conditions of Use. MR 
ICD protocol is based on ENABLE MRI study. 
China Food and Drug Administration (CFDA) requires certain clinical trial in China to 
support the approval of ImageReady™ MR conditional defibrillation system. 
5. Device Decription 
The ImageReady MR Conditional Defibrillation System included in the MR ICD Clinical 
Study, here to forward referred to as the ImageReady System, consists of DYNAGEN and 
INOGEN series pulse generators, RELIANCE 4-FRONT series defibrillation leads, 
ACUITY X4 series left ventricle (LV) leads, and INGEVITY series pacing leads for right 
atrium (RA). See Table 5-1. 
Table 5-1 ImageReady MR Conditional Defibrillation System Components 
Component 
Name 
Model 
Features 
Pulse 
Generators 
DYNAGEN 
D150 
Single chamber 
ICD, DF4 
D152 
Dual chamber 
ICD, DF4 
G158 
CRT-D, DF4, IS4 
INOGEN 
D140 
Single chamber 
ICD, DF4 
D142 
Dual chamber 
ICD, DF4 
G148 
CRT-D, DF4, IS4 
Defibrillation 
Leads 
RELIANCE 4-FRONT 
active fixation, single coil, 
Gore coating 
0692 
59cm 
0693 
64cm 
0657 
70cm 
RELIANCE 4-FRONT 
active fixation, dual coil, 
Gore coating 
0695 
59cm 
0696 
64cm 
0658 
70cm 
LV leads 
ACUITY X4 straight 
4671 
86cm 
4672 
95cm 
ACUITY X4 spiral S 
4674 
86cm 
4675 
95cm 

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ACUITY X4 spiral L 
4677 
86cm 
4678 
95cm 
RA leads 
INGEVITY  
passive fixation, J type 
7735 
45cm 
7736 
52cm 
INGEVITY  
active fixation, straight 
7740 
45cm 
7741 
52cm 
7742 
59cm 
INGEVITY  
passive fixation, straight 
7731 
52cm 
7732 
59cm 
DYNAGEN and INOGEN pulse generators, belonging to the new generation products of 
Galaxy, include single chamber ICD, dual chamber ICD and CRT-D, all capable of proiding 
defibrillation therapy. DYNAGEN and INOGEN pulse generators have the same hardware, 
while DYANGEN is more advance product with additional software functions such as 
ApneaScan,Wireless ECG and RhythmMatch. 
The pulse generators and leads listed in MR ICD study protocol have been approved by 
CFDA with non-MR conditional label. INGEVITY MRI series leads have been approved by 
CFDA with MR conditional label. 
The design of the DYNAGEN and INOGEN pulse generators has minimized the use of 
ferromagnetic materials which can interact with the fields generated in a typical MRI scan; 
the circuits have been designed to tolerate voltages that may be induced during scans; and the 
lead wire has been designed for use with the ImageReady pulse generators specifically to 
reduce absorption of energy from MRI fields, thus minimizing heating. 
DYNAGEN will be used as the only pulse generator in MR ICD study, while lead selection 
will be decided mainly by investigators based on subjects’ anatomy and clinical practice.  
BSC intends to label the ImageReady MR Conditional Defibrillation System models “MR 
Conditional” as defined by the American Society for Testing and Materials (ASTM) 3, when 
used as a system and in accordance with labeled Conditions of Use. 
 MRI Protection Mode 
Prior to an MRI scan, the pulse generator (PG) must be programmed to the MRI Protection 
Mode using the Programmer / Recorder / Monitor (PRM).  
Pacing mode options include asynchronous pacing (DOO, AOO, VOO) or no pacing (Off). 

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Asynchronous pacing should only be used if the subjects is pacing-independent. If MRI 
Protection Brady Mode is programmed to Off, the subject will not receive therapy until MRI 
Protection Mode is exited. Off should only be used if the subject is judged to be clinically 
capable of receiving no pacing during the time the pulse generator is in MRI Protection 
Mode, including during the scan. 
Considerations prior to choosing asynchronous pacing include: 
• 
Determine whether the patient is pacing-dependent. 
• 
Determine which chamber(s) need to be paced. 
• 
Consider the possibility of arrhythmia induction with asynchronous pacing. 
• 
Subjects with the following conditions may have increased risk of developing 
transient pacing-dependence: 
1. At risk for intermittent AV block (for example, those with progressive AV 
block, or a history of unexplained syncope) 
2. At risk for trifascicular block (alternating bundle branch block or PR interval > 
200 ms with LBBB or other bifascicular block) 
In the MRI Protection Mode, the following features and functions are suspended: 
• 
Bradycardia sensing 
• 
Tachycardia detection and therapy 
• 
PaceSafe™ automatic threshold(s) 
• 
Daily diagnostics (Lead Impedance, Intrinsic Amplitude, Pace Threshold) 
• 
Motion and respiratory sensors 
• 
Magnet detection 
• 
RF telemetry 
• 
Battery voltage monitoring 
• 
Beeper is disabled 
NOTE: In MRI Protection Mode there is no antitachycardia therapy available. 
Refer to the BSC ImageReady MR Conditional Defibrillation System MRI Technical Guide, 
here to forward referred to as the BSC MRI Technical Guide, for additional information 

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regarding MRI Protection Mode.  
 MRI Protection Mode Time-out Function 
The MRI Protection Mode Time-out function allows the user to choose the length of time the 
PG remains in the MRI Protection Mode before returning to previous settings. MRI 
Protection Mode is programmed using the PRM. The Time-out feature has programmable 
values of OFF, 3, 6, 9 and 12 hours. At the conclusion of the programmed duration the PG 
returns to the previously programmed therapy parameters and settings. MRI Protection Mode 
may also be exited manually at any time during the time-out period. If the MRI Protection 
Time-out value is programmed to OFF, the patient will not receive Bradycardia pacing, 
Cardiac Resynchronization Therapy, or Tachycardia therapy until the PG is programmed out 
of MRI Protection Mode and back to previous operation. Refer to the BSC MRI Technical 
Guide for additional information on the MRI Protection Mode Time-out Function. 
 Beeper Feature 
The Beeper in the PGs provides: (1) an audible patient warning when potential therapy 
failure is detected between scheduled PG checks with an HCP, and (2) audible feedback to 
HCP regarding the state of the PG such as, current tachycardia mode and when charging for 
shock therapy. The Beeper may no longer be audible following an MRI scan. Loss of Beeper 
volume cannot be recovered. 
It is strongly recommended that an in-clinic follow-up schedule of every three months 
after an MRI scan to monitor device performance. 
6. Conditions of Use 
The following MRI Conditions of Use must be satisfied as listed here and in the BSC MRI 
Technical Guide. Where differences exist between the BSC MRI Technical Guide and the EN 
MR ICD study protocol, the protocol extends the BSC MRI Technical Guide. 
 Cardiology 
1. Patient is implanted with an ImageReady MR Conditional Defibrillation System 
2. No other active or abandoned implanted devices, components. or accessories present 

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such as lead adaptors, extenders, leads, or pulse generators 
3. Pulse generator is in MRI Protection Mode during scan 
4. The patient must be continuously monitored by electrocardiography (ECG) during MR scan. 
Ensure backup therapy is available (external rescue). 
5. Patient is judged to be clinically capable of tolerating no Tachycardia protection. 
6. Patient does not have elevated body temperature or compromised thermoregulation at 
time of scan. 
7. Pulse generator implant location restricted to left or right pectoral region 
8. At least six (6) weeks have elapsed since implantation and/or any lead revision or 
surgical modification of the MR Conditional Defibrillation System 
9. No evidence of a fractured lead or compromised pulse generator-lead system integrity 
 Radiology 
1. MRI magnet strength 
RF field 
Maximum spatial gradient 
MRI equipment specification 
 
1.5 T only 
Approximately 64 MHz 
20T/m (2,000 G/cm) 
Horizontal, 1H proton, closed bore 
scanners only 
2. Specific Absorption Rate (SAR) 
limits for the entire active scan 
Normal Operating Modea: 
• Whole body averaged, ≤ 2.0 
watts/kilogram (W/Kg) 
• Head, ≤ 3.2 W/Kg 
3. Maximum specified gradient slew 
rate 
≤200 T/m/s per axis 
4. The use of receive-only coils is not restricted. Local transmit-only coils or local 
transmit/receive coils may be used, but should not be placed directly over the 
defibrillation system. 
5. Patient in supine or prone position only 
6. Patient must be continuously monitored by electrocardiography (ECG) for the 
entire duration MR scan. Ensure backup therapy is available (external rescue). 
 
a. As defined in IEC 60601-2-33, 201.3.224, 3rd Edition. 

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7. Objectives 
The objective of the study is to observe the safety and effectiveness of the ImageReady MR 
Conditional Defibrillation System when used in the 1.5T MRI environment under the labeled 
Conditions of Use in a Chinese population.  
8. Endpoints 
 Primary Safety Endpoint 
• 
MR Scan-related ImageReady System Complication-Free Rate between the MR Scan 
and the MRI + 1 Month Visit 
 Primary Effectiveness Endpoints 
1. Abnormal increase in RV shocking impedance from the pre-MR scan to the 1 Month 
post-MR scan 
2. Increase in RV pacing threshold (at 0.5ms) from the pre-MR scan to the 1 Month 
post-MR scan 
3. Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR 
scan 
4. Increase in LV pacing threshold (at 0.5ms) from the pre-MR scan to the 1 Month 
post-MR scan 
5. Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post- MR 
scan 
 Ancillary Assessments 
1. Assessment of RV and LV impedances 
2. Assessment of RA lead measurements 
3. Assessment of VT/VF episodes post-MR-scan 
4. Assessment of programming the MRI Protection Mode 
5. Assessment of Image Artifacts for non-medically necessary MR scans. 
The MR ICD study referenced FDA IDE trial ENABLE MRI. The major difference is that 
ENABLE MRI will collect 25 episodes of VT/VF events post MR scan, while the small 
sample size MR ICD study would use shocking impedance measurement to evaluate the 

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integrity of the shocking circuit. The MR ICD study will also assess any VT/VF event post 
MR scan. 
9. Design 
The MR ICD study is a multi-center, prospective, single –arm study in China. Phase I is 
completed when all the subjects finish MRI + 1 Month Visit, and the data will be 
summarized to support product CFDA registration. All subjects will be followed-up till 1 
year post implantation. 
 Scale and Duration 
The MR ICD study will enroll 20 subjects at approximately 5 investigator centers in China, 
including 10 ICDs (with at least 2 single chamber ICDs and 2 dual chamber ICDs) and 10 
CRT-D. The PGs will be DYNAGEN series and there is no further requirement for leads (see 
Table 5-1). 
Data will be collected from subjects upon enrollment into the study, at implant, and at 
pre-discharge. Subjects will have an MR scan at 6-9 weeks post-implant, or at least 6 weeks 
after any required surgical interventions to the ImageReady System (labeled as MRI Visit). 
Subsequently, there will be a clinic follow up at MRI + 1 Month Visit, and recommended 
clinic follow up every 3 months post MR scan. Subjects will also be followed at 1 year 
post-implant, see Figure 9-1. 
The MR ICD study is composed of two phases. Phase I is completed when all the subjects 
finish MRI + 1 Month Visit, which starts Phase II till 1 year post implantation. Phase I is 
expected to last about 9 months after first subject enrollment, and the whole study is expected 
to last about 20 months after first subject enrollment. 

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Figure 9-1 MR ICD study Design 
 
 Justification for the Study Design 
BSC is conducting a global multi-center study, ENABLE MRI (NCT02652481), on MR 
conditional systems including DYNAGEN and INOGEN. The study will enroll 500 subjects, 
to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation 
System when used in the 1.5T MRI environment under the labeled Conditions of Use. CFDA 
requires certain clinical trial in China to support the approval of ImageReady™ MR 
conditional defibrillation system. 
The MR ICD study referenced ENABLE MRI. The major difference is that ENABLE MRI 
will collect 25 episodes of VT/VF events post MR scan, while the small sample size MR ICD 
study would use shocking impedance measurement to evaluate the integrity of the shocking 
circuit. The MR ICD study will also assess any VT/VF event post MR scan. 

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The MR ICD study is composed of two phases. Phase I is completed when all the subjects 
finish MRI + 1 Month Visit, and the data will be summarized to support product CFDA 
registration. All subjects will be followed-up till 1 year post implantation. 
10. Subject Selection 
 Study Population and Eligibility  
Subjects enrolled in the MR ICD study shall be selected from the investigators general 
patient population indicated for an ICD or CRT-D implantation. The Investigator is 
responsible for screening potential subjects and selecting those who meet the eligibility 
criteria for the study as described in Sections 10.2 and 10.3. 
 Inclusion Criteria 
Subjects who meet all of the following criteria may be given consideration for inclusion in 
this clinical investigation, provided no exclusion criteria are met (see 10.3). 
1. Subject is indicated to Class I/II indications per guidelines/consensus released by 
Chinese Society of Cardiac Pacing and Electrophysiology4, 5 
2. Subject must have the ImageReady System as their initial (de novo) defibrillation 
system implant 
3. Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral 
region ICD 
4. Subject is able and willing to undergo an MR scan 
5. Subject is willing and capable of providing informed consent and participating in all 
testing/ visits associated with this clinical study at an approved clinical study center 
and at the intervals defined by this protocol 
6. Subject is age 18 or above 
 Exclusion Criteria 
Subjects who meet any one of the following criteria will be excluded from the MR ICD 
study. 
1. Subject has other active or abandoned implanted cardiac rhythm devices, components 
or accessories present such as pulse generators, leads, lead adaptors or extenders  

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2. Presence of metallic objects that represent a contraindication to MR imaging at the 
discretion of the Radiologist and impacting the ability to conduct the study protocol  
3. Subject needs or will need a medically necessary MR scan, before completing the 
1-month post-MR follow-up visit 
4. Subject is not clinically capable of tolerating the absence of Tachycardia therapy 
support for the duration that the pulse generator is in MRI Protection Mode, per 
Physician discretion 
5. Subjects currently requiring dialysis 
6. Subject has a mechanical heart valve 
7. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) 
8. Subject is currently on the active heart transplant list 
9. Subject has documented life expectancy of less than 12 months 
10. Subject is enrolled in any other concurrent study that might interfere with this study 
11. Women of childbearing potential who are or might be pregnant at the time of this 
study 
11. Subject Accountability 
 Enrollment 
Subjects will be considered enrolled into the MR ICD study at the time of informed consent 
form execution. All subject enrollments will be counted against the enrollment ceiling for the 
study. 
 Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems 
related to investigational device safety or performance, the investigator shall ask for the 
subject’s permission to follow his/her status/condition outside of the clinical study. 
Reasons for withdrawal include, but are not limited to: subject not receiving a protocol 
required defibrillation system, physician discretion, subject choice to retire consent, loss to 

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follow-up, or death. While study withdrawal is discouraged, subjects may withdraw from the 
MRI ICD Study at any time, with or without reason, and without prejudice to further 
treatment. All applicable case report forms up to the point of subject withdrawal must be 
completed. Additional study data may no longer be collected after the point at which a 
subject has been withdrawn from the study or withdraws his/her consent, for whatever reason. 
All open adverse events should be closed or documented as chronic. Data collected up to the 
point of subject withdrawal may be used. 
 Subject Status and Classification 
Subjects enrolled in the MR ICD study will be placed into one of four classifications, as 
defined below. 
Intent - Intent refers to a subject who has been enrolled, but does not have the lead(s) or PG 
introduced into their body. There are no follow-up requirements for intent subjects. The 
original informed consent form (ICF) for intent subjects should be maintained in the Center’s 
files. 
Attempt - Attempt refers to a subject who has had the lead(s) and/or PG introduced into the 
body, but is not successfully implanted with any portion of the ImageReady System during 
the implant procedure. Attempt subjects must be followed 30 ± 7 days post-attempted 
ImageReady System implant to assure there are no associated adverse events, or to assure the 
resolution of any adverse events associated with the attempted ImageReady System implant, 
then withdrawn from the study. 
Partial Implant - Partial Implant refers to a subject who is implanted with a component of 
the ImageReady System (lead or pulse generation) during the implant procedure, but does not 
end up with a complete ImageReady System. They shall not receive the protocol required 
MR Scan according to the BSC MRI Technical Guide. Partial Implant subjects must be 
followed 30 ± 7 days post- ImageReady System implant to assure there are no associated 
adverse events, or to assure the resolution of any adverse events associated with the 
ImageReady System implant, then withdrawn from the study. 
Implant - Implant refers to a subject who is successfully implanted with the ImageReady 
System per the study protocol. These subjects are followed in accordance with the follow-up 

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schedule and included in all analyses of safety and performance.  
 Enrollment Controls 
According to the study protocol, 10 ICD subjects (at least 2 single chamber ICDs and 2 dual 
chamber ICDs) and 10 CRT-D subjects will be enrolled. It should be ensured that at least 8 
ICD subjects (at least 1 single chamber ICD and 1 dual chamber ICD) and 8 CRT-D subjects 
undergo protocol required MR scan and complete all the sequences. It should be ensured that 
both single coil and dual coil defibrillation leads are implanted. It should be ensured that both 
straight and spiral LV leads are implanted. Subject enrollment might be expanded to meet the 
above requirement to support product registration. 
Generally, one individual center may not enroll more than 10 subjects. Investigational sites 
will be notified when the enrollment goal is close to being reached and once enrollment is 
complete. 
 End-of-Study Action Plan 
Phase I is completed when all the subjects finish MRI + 1 Month Visit, and the data will be 
summarized to support product CFDA registration. All subjects will be followed-up till 1 
year post implantation in Phase II. After that, subjects will receive routine clinical practice at 
each center. 
12. Study Methods 
 Data Collection 
The data collection schedule for the MR ICD study is shown in Table 12-1. 
 Study Candidate Screening 
For the MR ICD Study, physician investigators are responsible for screening all potential 
patients and selecting those who are appropriate for study inclusion. The patients selected for 
participation should be from the investigator’s general patient population. 
 Informed Consent 
Patients who appear to meet all of the inclusion criteria and none of the exclusion criteria and 
agree to participate in the MR ICD study must give written informed consent approved by 

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the EC prior to study participation and use of any investigational product or testing/ data 
collection. Patients who sign informed consent for the MR ICD study will be considered 
enrolled in the study at the point of executing an ICF. 
 Enrollment Visit 
The data to be collected during enrollment into the MR ICD study comprise of subject 
demographic data including age, ethnicity and gender, medical history including arrhythmia 
history, cardiac disease history, and current cardiovascular medications, a physical 
assessment of the subject including height, weight, heart rate and blood pressure. 
If the subject has metal objects in body, radiologist approval to undergo MRI scan should be 
documented. A pregnancy test must be performed within 7 days prior to the index procedure 
in women of child-bearing potential. 
12.4.1. Enrollment Source Data Requirements 
Source data requirements at Enrollment are described in Table 12-2. 

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Table 12-1 Data Collection Schedule 
Procedure /Assessment 
Enrollment Implant 
Pre-Discharge MRI Visit 
 
MRI+ 
1Month 
Visit 
MRI+ 
Every 
Three-Month 
Visits 
Implant+ 
1Year 
Visit 
Additional 
Visits 
Medically 
necessary 
MRI 
Timeframe 
≤ 30 days 
prior to 
Implant 
Implant 
Day 0 
3-72 hours 
from Implant 
6-9 
weeks from 
Implanta 
30 ± 7 
days from 
MRI Visit 
90 ± 14 days 
from MRI 
Visitb  
365±45 
days  
from 
implant 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Physical assessment 
X 
 
 
 
 
 
 
 
 
Pregnancy test 
X 
 
 
 
 
 
 
 
 
Device implant 
 
X 
 
 
 
 
 
 
 
MR Scan 
 
 
 
X 
 
 
 
 
X 
Device evaluation 
 
X 
X 
X pre&post 
X 
X 
X 
O 
O 
Beeper evaluation 
 
 
 
X pre&post 
 
 
 
 
X pre&post 
Save all 
 
 
 
X 
X 
 
X 
O 
O 
Printout of device settings 
and history 
 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
a must occur at least 6 weeks after surgical revision of the ImageReady System 
b The first Every 3-month visit will occur 90 ± 14 days after MRI visit. Subsequent Every 3-month follow-up visits will be scheduled every three months (90 days 
± 14 Days) from the previous scheduled study follow-up. 
c A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential. 

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Table 12-2 Enrollment Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Informed consent form and process 
Retain at center 
Demographic, Medical history and Physical assessment 
Completed Radiologists Technical Source Form 
(applicable for subjects with metallic implants only) 
Adverse events 
 Implant 
The implant procedure will occur either on the same day as enrollment, after the subject signs 
and dates the informed consent form, or up to 30 days later. 
To satisfy the MRI Conditions of Use (see Section 6), the PG must be implanted in the left or 
right pectoral (subcutaneous or sub-muscular) regions. The implant procedure end time is 
defined as the time of device pocket closure. Record the end time in the electronic data 
capture (EDC) system. 
12.5.1. Device Evaluation 
All implanted leads will be evaluated through the implanted PG using the test parameters 
listed in Table 12-3:  
• 
Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3. 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
Record the measurements in the EDC system. 
Table 12-3 Test Parameters 
Description 
RA Threshold Test RV Threshold Test 
LV Threshold Test 
Test Type 
Amplitude 
Amplitude 
Amplitude 
Pulse Width (ms) 
0.5 
0.5 
0.5 
Cycles per Step 
3 (minimum) 
3 (minimum) 
3 (minimum) 
Pacing Lead 
Configuration 
Not Programmable Not Programmable 
Per HCP 
For MRI and MRI + 1 
Month visits: The same 
LV Pacing Configuration 
must be used for 
threshold testing 

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Impedance 
Tests 
RA Impedance 
Test 
RV Impedance 
Test 
LV Impedance Test 
Pacing Lead 
Configuration 
Bipolar 
Bipolar 
Same LV configuration 
as the Pacing Test 
 
For MRI and MRI +1 
Month visits: The same 
LV Pacing Configuration 
must be used for 
impedance testing 
Sensing Tests 
RA Sensing Test 
RV Sensing Test 
LV Sensing Test 
Sensing 
Configuration 
Bipolar 
Bipolar 
Per HCP 
For MRI and MRI+1 
Month visits: The same 
LV Sensing 
Configuration must be 
used for sensing testing 
Shock Impedance 
Tests 
 
RV Shock 
Impedance Tests 
 
 
 
Per HCP 
For MRI and 
MRI+1 Month 
visits: The same 
RV Shock 
Impedance 
Configuration must 
be used for 
impedance testing 
 
Note: Mode, Lower Rate Limit, Amplitude, Paced AV delay and LV Pacing Lead 
Configuration shall be set per physician or HCP discretion. 
12.5.1.1. Manual Right Atrial Threshold Test 
If the subject does not have an active implanted RA lead, then skip to the next section. 
Otherwise, perform a manual RA threshold test following these steps, unless the testing is 
inhibited by a patient condition (example: subject is in atrial fibrillation):  
1. In the Atrial Threshold Test screen set the Test Type to Amplitude  
2. Mode, Lower Rate Limit, Amplitude and Paced AV delay shall be set per physician or 
HCP discretion 

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3. Pulse Width shall be set to 0.5 ms 
4. Cycles per Step shall be set to a minimum of 3 
5. Start the annotated real-time ECG from the PRM, then start the manual RA threshold 
test 
1) A count of 2 non-capture beats at a given voltage level is required to declare loss of 
capture (LOC) 
2) If the subject experiences discomfort during the threshold test due to extracardiac 
stimulation, then stop the test and perform the manual threshold test per physician 
discretion. 
6. When LOC is determined, stop the threshold test. Stop the PRM real-time ECG a 
minimum of 2 seconds after LOC is determined.  
7. Label the PRM ECG with the subject ID#, date, Visit name, and “Manual RA 
threshold test”. 
8. The threshold for the manual RA threshold test is defined as one voltage level above 
the level where the 2 non-captured beats are observed. Record the threshold in the 
EDC system. 
9. If the threshold saved on the PRM does not match the threshold, as defined in step 8, 
then update the RA Pace Threshold in the programmer. 
12.5.1.2. Manual Right Ventricular Threshold Test 
Perform a manual RV threshold test following these steps: 
1. In the Right Ventricular Threshold Test screen set the Test Type to Amplitude  
2. Mode, Lower Rate Limit, Amplitude and Paced AV delay shall be set per physician or 
HCP discretion 
3. Pulse Width shall be set to 0.5 ms 
4. Cycles per Step shall be set to a minimum of 3 
5. Start the annotated real-time ECG from the PRM, then start the manual RV threshold 
test 
1) A count of 2 non-capture beats at a given voltage level is required to declare loss of 
capture (LOC) 

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2) If the subject experiences discomfort during the threshold test due to extracardiac 
stimulation, then stop the test and perform the manual threshold test per physician 
discretion. 
6. When LOC is determined, stop the threshold test. Stop the PRM real-time ECG a 
minimum of 2 seconds after LOC is determined.  
7. Label the PRM ECG with the subject ID#, date, Visit name, and “Manual RV 
threshold test”. 
8. The threshold for the manual RV threshold test is defined as one voltage level above 
the level where the 2 non-captured beats are observed. Record the threshold in the 
EDC system. 
9. If the threshold saved on the PRM does not match the threshold, as defined in step 8, 
then update the RV Pace Threshold in the programmer. 
12.5.1.3. Manual Left Ventricular Threshold Test 
If the subject does not have an active implanted LV lead, then skip to the next section. If 
multiple manual LV threshold tests are performed, then record the manual LV threshold test 
that matches the final programmed LV lead configuration following these steps: 
1. In the Left Ventricular Threshold Test screen set the Test Type to Amplitude  
2. Mode, Lower Rate Limit, Amplitude and Paced AV delay shall be set per physician or 
HCP discretion 
3. Pulse Width shall be set to 0.5 ms 
4. Cycles per Step shall be set to a minimum of 3 
5. Start the annotated real-time ECG from the PRM, then start the manual LV threshold 
test 
1) A count of 2 non-capture beats at a given voltage level is required to declare loss of 
capture (LOC) 
2) If the subject experiences discomfort during the threshold test due to extracardiac 
stimulation, then stop the test and perform the manual threshold test per physician 
discretion. 
6. When LOC is determined, stop the threshold test. Stop the PRM real-time ECG a 

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minimum of 2 seconds after LOC is determined.  
7. Label the PRM ECG with the subject ID#, date, Visit name, and “Manual LV 
threshold test”. 
8. The threshold for the manual LV threshold test is defined as one voltage level above 
the level where the 2 non-captured beats are observed. Record the threshold in the 
EDC system. 
9. If the threshold saved on the PRM does not match the threshold, as defined in step 8, 
then update the LV Pace Threshold in the programmer. 
12.5.2. Completing the Implant Visit 
1. Program the device according to physician discretion 
2. Print the ‘Quick Notes’ Report 
12.5.3. Implant Source Data Requirements 
Source data requirements at implant are described in Table 12-4. 
Table 12-4 Implant Source Documentation Requirements  
Source Documentation Requirement 
Disposition 
Device model/serial number 
Retain at center 
Lead model/serial numbers for all implanted leads 
Device Evaluation (pace thresholds, sense amplitudes, 
impedances, RV shock impedance) 
PRM ECG strips from manual threshold tests documenting 
LOC for all implanted leads 
Printout of ‘Quick Notes’ Report 
Adverse Events 
 
 Pre-Discharge 
12.6.1. Device Evaluation 
The Pre-discharge Visit will occur either on the same day as the ImageReady System implant 
procedure, a minimum of 3 hours after pocket closure, or up to 72 hours after the implant 
procedure. 
All implanted leads will be evaluated through the implanted PG using the test parameters 
listed in Table 12-3:  

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• 
Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3. 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
Record the measurements in the EDC system. 
12.6.2. Completing the Pre-Discharge Visit 
1. Program the device according to physician discretion 
2. Print the ‘Quick Notes’ Report 
3. Schedule the MRI follow-up visit. 
12.6.3. Pre-Discharge Source Data Requirements 
Source data requirements at Pre-discharge Visit are described in Table 12-5. 
Table 12-5 Pre-Discharge Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance) 
Retain at center 
PRM ECG strips from manual threshold tests documenting 
LOC for all implanted leads 
Printout of ‘Quick Notes’ Report 
Adverse Events 
 
 MRI Visit 
The MRI Visit will occur 6 to 9 weeks (42-63 days) after implant or surgical revision ((i.e., a 
lead revision/ reposition) of the ImageReady System implant. 
12.7.1. Device Evaluation Prior to Commencement of MR Scan 
1. All implanted leads will be evaluated through the implanted PG for THREE separate 
consecutive sets of measurements using the test parameters listed in Table 12-3: 
• 
Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3. 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 

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2. Test for phrenic nerve stimulation (PNS) and measure the PNS threshold if detected in 
the programmed LV lead configuration 
3. Perform an evaluation of Beeper function as defined in section 12.7.1.1. 
4. Print the ‘Quick Notes’ Report 
Record the measurements in the EDC system. 
12.7.1.1. Evaluation of Beeper function 
To test if the Beeper is audible, 
1. Program Magnet Response to Inhibit Therapy 
2. Place the magnet over the PG for a minimum of 5 seconds but not for more than 20 
seconds in a quiet environment. 
• 
If the Tachy mode is programmed to ‘Monitor + Therapy’: A short beep may be 
heard once every second, as long as the magnet is placed over the PG. 
• 
If the Tachy mode is programmed to ‘Monitor only’ or ‘OFF’: A continuous beep 
may be heard as long as the magnet is placed over the PG. 
Note: The Magnet Sensor will detect magnets (donut, horseshoe or wrist) within 3 cm. 
The Magnet Sensor will detect a 60 G < field ≤300 G, when applied perpendicularly to 
the surface of the PG, either face. 
3. The subject and the HCP will be asked to indicate whether the Beeper is audible to them. 
4. If not audible, by either the subject or the HCP, a second attempt at evaluating Beeper 
function will be performed. The Beeper should be assessed in the alternate Tachy mode 
(as listed in step 2) if tolerated by the subject. 
5. Record if the Beeper was audible by the subject and the HCP in the EDC. 
12.7.2. Subject Evaluation Prior to Commencement of MR Scan 
12.7.2.1. Confirmation of MRI Conditions of Use 
Subjects must meet the MRI Conditions of Use, comprised of Cardiology and Radiology 
Conditions of Use, as listed in the BSC MRI Technical Guide and Section 6 of this protocol. 

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12.7.2.2. Heart Rhythm Monitoring prior to MRI protection mode programming 
It is required that the heart rhythm be monitored by the site Principal Investigator or a 
subinvestigator for all subjects prior to initiation of the MRI Protection Mode and the MR 
Scan. Heart rate and any abnormal rhythms, including incidence of ectopy shall be 
documented. Any abnormal rhythms / ectopy shall be documented with a printed ECG or 
rhythm strip if possible. 
12.7.3. MR Scans 
The MR scan must be performed within the guidelines of this protocol and the BSC MRI 
Technical Guide. When differences exist, the ENABLE MRI Study protocol extends the BSC 
MRI Technical Guide. 
MRIs must be performed in 1.5 Tesla, closed bore scanners with body coil excitation. 
Subjects will complete MR scans per the MR scan sequences protocol in Section 29 of this 
protocol. 
Note: Incidental findings are defined as a “finding concerning an individual research 
participant that has potential health or reproductive importance and is discovered in the 
course of conducting research but is beyond the aims of the study6”. The MR scans required 
by the ENABLE MRI Study are not intended for diagnostic purposes. Therefore, they are not 
intended or required to be read by trained radiologists. If the site’s MR technician performing 
the scan determines any incidental findings, or if a site’s procedures dictate that MR scans 
must be read, any incidental findings must be reported to the site’s primary investigator by 
the person who reads the scan. 
12.7.3.1. Programming MRI Protection Mode 
Prior to undergoing an MR scan, the ImageReady System must be programmed to the MRI 
Protection Mode and an appropriate pacing mode is set using the PRM. The PRM is to be 
kept ON and in MRI Zone I or II as close to the MRI room as possible. 
WARNING: The PRM is MR Unsafe and must remain outside the MRI site Zone III (and 
higher) as defined by the American College of Radiology Guidance Document for Safe MR 
Practices11. Under no circumstances should the PRM be brought into the MRI scanner room, 
(Zone IV), or the control room (Zone III). Programming the PG to MRI Protection Mode 

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should be done as close to the planned start of the MR scan as possible. 
1. Start monitoring the subject 
2. Program the MRI Protection Time-out (nominal setting: 6 hours; programmable 
values are OFF, 3, 6, 9, 12 hours) 
3. Program the PG to the MRI Protection Mode, set up appropriate pacing parameters 
4. Print the MRI Protection Settings Report. This report documents the MRI Protection 
Mode settings and details. 
a. If the Time-out feature is used, the report includes the exact time and date 
when MRI Protection Mode will expire. If the Time-out feature is used, the 
MRI technologist/radiologist must verify that adequate time remains to 
complete the scan and to exit the MR scanner room. 
Please refer to the BSC MRI Technical Guide for more information regarding PG MRI 
Protection Mode programming and other associated MRI warnings, cautions, and potential 
adverse events. 
12.7.3.2. Monitoring of Subjects during the MRI Protection Mode 
Subjects must be continuously monitored by the site Principal Investigator or a 
sub-investigator for the entire duration of the MR scan. For the entire duration of the MR 
scan, the following will be performed: 
1. Continuous ECG monitoring of the subjects 
2. Ensure that an external defibrillator and medical personnel trained in external 
defibrillation and cardiopulmonary resuscitation (CPR) are present  
3. Subjects must be continuously monitored by the site Principal Investigator or a 
sub-investigator using ECG, along with maintaining voice and visual contact. 
4. In addition, for the entire duration of the MR scan, the following will be 
performed: 
a. The heart rate will be documented in 5 ± 2 minutes intervals. 
b. ECG alarms must be ON. 
c. It is recommended that a rhythm strip is printed at each interval. 

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d. If there are any abnormal rhythms, a rhythm strip to document the abnormal 
rhythm should be printed if possible 
12.7.3.3. MR Scan Sequences Protocol 
Refer to Table 29-1 in Section 29 for the MR Scan Sequences Protocol. 
The following data is required to be collected: 
1. Medications used for sedation in the MR scanner, if applicable 
2. MR Scanner manufacturer and model 
3. Time of MR scan initiation 
4. Time duration for each sequence within the RF intensive and Gradient intensive 
scans 
5. Total duration of RF intensive scan sequences 
6. Total duration of Gradient intensive scan sequences 
7. Time of MR scan completion 
12.7.3.4. Exiting the MRI Protection Mode 
Upon completion of the MR scan, program the PG out of the MRI Protection Mode. It is 
recommended to program the PG out of MRI Protection Mode as close to the end of MR 
scan as possible. 
• 
Document the Time of exiting MRI Protection Mode. 
Note: The PRM is MR Unsafe and must remain outside the MRI site Zone III (and higher). 
Under no circumstances should the PRM be brought into the MRI scanner room, the control 
room, or the MRI site Zone III or IV areas. 
Upon exiting the MRI Protection Mode, all parameters are restored to pre-MRI Protection 
Mode values with two exceptions: 
• 
Restoration of function of the Minute Ventilation (MV) sensor is delayed. If MV was 
programmed to ON or Passive at the time of entry into MRI Protection Mode, upon exit 
from the mode, an automatic six hour calibration of the sensor will begin. MV-driven 
rate response is not available during this calibration period. If MV-driven rate response 
is desired sooner, a manual calibration can be performed. 

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• 
The Beeper will remain OFF upon exiting MRI Protection Mode. 
12.7.4. Device Evaluation after the MR Scan 
1. All implanted leads will be evaluated within two hours upon exit from the MRI 
Protection Mode through the implanted PG for THREE separate consecutive sets of 
measurements using the test parameters listed in Table 12-3:  
• 
Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3. 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
2. Test for phrenic nerve stimulation (PNS) and measure the PNS threshold if detected in 
the programmed LV lead configuration. 
3. Perform an evaluation of Beeper function as defined in section 12.7.1.1. 
Record the measurements in the EDC system. 
12.7.5. Completing the MRI Visit 
1. The PG data must be reviewed to document whether any episodes of polymorphic or 
monomorphic VT or VF that required ATP or shock therapy are present, following the 
MR scan. 
a. If polymorphic or monomorphic VT or VF episodes are present: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters and 
EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is expected 
to be submitted to Boston Scientific within 5 business days using the upload 
tool in the EDC system  
2. Program the device according to physician discretion, and indicate if any permanent 
device programming was changed 
3. Print the ‘Quick Notes’ Report 
4. Perform a Save All: 

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a. Save device data to a USB using the programmer “Save All” feature  
b. Label the USB with the subject ID#, Date, and “MRI” 
c. Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific using the upload tool in the EDC system. Do not make a copy by 
using the programmer a second time as this will create a new USB with slightly 
different information. 
5. Schedule the MRI+1 Month follow-up visit. 
6. Assessment of the quality of the MR image. Radiologist from the investigate site will 
score the image quality from 1 to 5 based on comparison with site usual scans, with 1 
completely unreadable and 5 similar to usual scans. 
12.7.6. MRI Visit Source Data Requirements 
Source data requirements at the MRI Visit are described in Table 12-6: 
Table 12-6 MRI Visit Source Documentation Requirements  
Source Documentation Requirement 
Disposition 
Pre-MR scan: 
• 
Device Evaluation (pace threshold, sense 
amplitude, impedance, RV shock impedance, LV 
Phrenic Stimulation threshold) 
• 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
• 
Evaluation of Beeper function 
• 
Printout of ‘Quick Notes’ Report 
• 
Cardiology and Radiology MRI Conditions of Use 
are satisfiedAbnormal rhythms / ectopy (if 
possible) 
• 
 
Retain at center 
MR scan: 
• 
MRI Protection Settings Report 
• 
Heart rate in 5 ± 2 minute intervals 
• 
Medications used for sedation in the MR scanner, 
if applicable 
• 
MR Scanner manufacturer and model 
• 
Time of MR scan initiation 
Retain at center 

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• 
Time duration for each sequence within the RF 
intensive and Gradient intensive scans 
• 
Total duration of RF intensive scan sequences 
• 
Total duration of Gradient intensive scan 
sequences 
• 
Time of MR scan completion 
When PG is programmed out of MRI Protection Mode: 
• 
Time of exiting MRI Protection Mode 
Retain at center 
Post-MR scan: 
• 
Device Evaluation (pace threshold, sense 
amplitude, impedance, RV shock impedance, LV 
Phrenic Stimulation threshold) 
• 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
• 
Evaluation of Beeper function 
• 
Document if polymorphic or monomorphic 
VT/VF episodes requiring therapy, are present 
• 
Documentation of spontaneous VT/VF episode(s) 
by PRM strips, as applicable: 
◼ ‘Selected Episodes Report’ (counters and 
EGMs required) 
◼ ‘Arrhythmia Logbook’ 
• 
Printout of ‘Quick Notes’ Report 
• 
Assessment of MR scan image quality 
Retain at center 
Adverse Events 
Retain at center 
MR scanner DICOM dump/ report file including items 
such as scan sequence settings and durations as well as 
calculated scan metrics such as whole body average 
SAR. 
The DICOM file must contain both images and scan 
sequence data. 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
Save All 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
 

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 MRI + 1 Month Visit 
The MRI + 1Month Visit must be performed as a clinic visit and will occur at 30 ± 7 days 
after the MRI Visit. 
12.8.1. Device Evaluation 
1. All implanted leads will be evaluated through the implanted PG for THREE separate 
consecutive sets of measurements using the test parameters listed in Table 12-3: 
• 
Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3. 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
2. Test for phrenic nerve stimulation (PNS) and measure the PNS threshold if detected in 
the programmed LV lead configuration 
3. Record the measurements in the EDC system. 
12.8.2. Completing the MRI + 1 Month Visit 
1. The PG data must be reviewed to document whether any episodes of polymorphic or 
monomorphic VT or VF that required ATP or shock therapy are present, following the 
MR Visit. 
a. If polymorphic or monomorphic VT or VF episodes are present: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters and 
EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is expected 
to be submitted to Boston Scientific within 5 business days using the upload 
tool in the EDC system 
2. Program the device according to physician discretion, and indicate if any permanent 
device programming was changed 
3. Print the ‘Quick Notes’ Report 
4. Perform a Save All: 

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a. Save device data to a USB using the programmer “Save All” feature  
b. Label the USB with the subject ID#, Date, and “MRI + 1 Month” 
c. Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific using the upload tool in the EDC system. Do not make a copy by 
using the programmer a second time as this will create a new USB with slightly 
different information. 
5. Schedule the MRI+1 Year follow-up visit. 
12.8.3. MRI + 1 Month Visit Source Data Requirements 
Source data requirements at MRI+1 month Visit are described in Table 12-7: 
Table 12-7 MRI + 1 Month Source Documentation Requirements  
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance, LV Phrenic 
Stimulation threshold) 
Retain at center 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
Printout of ‘Quick Notes’ Report 
Documentation of spontaneous VT/VF episode(s) by 
PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs 
required) 
• 
‘Arrhythmia Logbook’ 
Adverse Events 
Save All 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
 
 Every Three-month Follow ups through Three Years (Recommended) 
An in-clinic follow-up schedule of every three months is strongly recommended to monitor 
device performance. The first Every 3-month visit will occur 90 ± 14 days after MRI visit. 
Subsequent Every 3-month follow-up visits will be scheduled every three months (90 days ± 
14 Days) from the previous scheduled study follow-up. 

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12.9.1. Device Evaluation 
1. The standard of care evaluation for device performance is recommended. Record the 
available measurements in the EDC system.  
• 
Pacing thresholds 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
2. If any new episodes of polymorphic or monomorphic VT or VF that required ATP or 
shock therapy are present since the prior study visit: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters and 
EGMs) 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is expected 
to be submitted to Boston Scientific within 5 business days using the upload 
tool in the EDC system 
3. Program the device according to physician discretion, if applicable 
4. Print the ‘Quick Notes’ Report 
12.9.2. Every Three-month Visit Source Data Requirements 
Source data requirements at Every Three-month visits are described in Table 12-8.  
Table 12-8 Every Three Month Source Documentation Requirements  
Source Documentation Requirement 
Disposition 
Documentation of spontaneous VT/VF episode(s) by 
PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs 
required) 
• 
‘Arrhythmia Logbook’ 
Retain at center 
Printout of ‘Quick Notes’ Report 
Adverse Events 
 
 Implant + 1Year Visit 
The Implant + 1Year Visit must be performed as a clinic visit and will occur at 365 ± 45 days 

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after implant. 
Device Evaluation 
1. The standard of care evaluation for device performance is recommended. Record the 
available measurements in the EDC system.  
• 
Pacing thresholds 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
2. If any new episodes of polymorphic or monomorphic VT or VF that required ATP or 
shock therapy are present since the prior study visit: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters and 
EGMs) 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is expected 
to be submitted to Boston Scientific within 5 business days using the upload 
tool in the EDC system 
3. Program the device according to physician discretion, if applicable 
4. Print the ‘Quick Notes’ Report 
5. Perform a Save All: 
a) Save device data to a USB using the programmer “Save All” feature  
b) Label the USB with the subject ID#, Date, and “MRI + 1 Year” 
c) Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific using the upload tool in the EDC system. Do not make a copy by 
using the programmer a second time as this will create a new USB with slightly 
different information. 
12.10.1. Implant + 1 Year Visit Source Data Requirements 
Source data requirements for Implant +1 Year Visit are described in Table 12-9. 
Table 12-9 Implant + 1Year Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, 
Retain at center 

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impedance, RV shock impedance) 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
Documentation of spontaneous VT/VF episode(s) by 
PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs 
required) 
• 
‘Arrhythmia Logbook’ 
Printout of ‘Quick Notes’ Report 
Adverse Events 
Save All 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
 
 Additional Visits 
An Additional Follow-up Visit will be reported when an office/clinic visit identifies a 
reportable event and the device is interrogated. If possible, a device evaluation and lead 
measurements should be performed and the results recorded in the EDC system. 
12.11.1. Required Data Collection 
1. Complete the Additional Follow-up form 
2. Collect any adverse event information 
3. Print the ‘Quick Notes’ Report 
12.11.2. Recommended Data Collection 
1. It is recommended to conduct a device evaluation: 
• 
Manual pacing threshold tests 
• 
Sensing amplitude 
• 
Impedance 
• 
Shock impedance (RV lead only) 
2. For all additional visits after an MR scan, the PG data should be reviewed. If any new 
episodes of polymorphic or monomorphic VT or VF that required ATP or shock therapy 
are present since the prior study visit: 

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i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters and 
EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is expected 
to be submitted to Boston Scientific within 5 business days using the upload 
tool in the EDC system 
3. Perform a Save All: 
a) Save device data to a USB using the programmer “Save All” feature  
b) Label the USB with the subject ID#, Date, and “Additional Follow-up” 
c) Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific using the upload tool in the EDC system. Do not make a copy by 
using the programmer a second time as this will create a new USB with slightly 
different information. 
12.11.3. Additional Follow-up Visit Source Data Requirements 
Source data Requirements at Additional Follow-up Visit are described in Table 12-10. 
Table 12-10 Additional Follow-up Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance) 
 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
 
Documentation of spontaneous VT/VF episode(s) by 
PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs 
required) 
• 
‘Arrhythmia Logbook’ 
Retain at center 
Printout of ‘Quick Notes’ Report 
Adverse Events 
Save All, as applicable 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
Text in table that is italicized is recommended 

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 Medically Necessary MRI Visits 
During the study, if a subject needs a medically necessary MR scan, BSC recommends the 
subject be directed to have the scan at the Study site. 
Note: In case the medically necessary MR scan is performed at a non-investigational site, all 
efforts must be made to collect the data and adhere to the MRI Conditions of Use. 
Study flow is identical to the MRI visit as described in section 12.7. Some data collection is 
optional for Medically Necessary MRI visit as shown in italic in Table 12-11. 
For medically necessary MRI scans, all activities performed by the site Principal Investigator 
or a sub-investigator at the MRI visit (i.e. heart rhythm monitoring) can be performed by a 
trained and qualified Health Care Professional (HCP). 
As for the MRI visit, it is recommended to have a programmer powered ON in Zone II near 
the MRI room in case the patient develops the urgent need for pacing. 
12.12.1. Medically Necessary MRI Visit Source Data Requirements 
Source data Requirements for medically necessary MR scans are described in Table 12-11: 
Table 12-11 Medically Necessary MRI Visit Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Pre-MR scan: 
• 
Body part scanned 
• 
Assessment of patient history of unexplained 
syncope 
• 
Device Evaluation (pace threshold, sense 
amplitude, impedance, RV shock impedance, LV 
Phrenic Stimulation threshold) 
• 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
• 
Evaluation of Beeper function 
• 
Printout of ‘Quick Notes’ Report 
• 
Cardiology and Radiology MRI Conditions of Use 
are satisfied 
Retain at center 
MR scan: 
• 
MRI Protection Settings Report 
• 
Time of MR scan initiation 
• 
Time of MR scan completion MRI  
Retain at center 

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• 
Heart rate in 5 ± 2 minute intervals 
• 
Medications used for sedation in the MR scanner, 
if applicable 
• 
MR Scanner manufacturer and model 
When PG is programmed out of MRI Protection Mode: 
• 
Time of exiting MRI Protection Mode 
Retain at center 
Post-MR scan: 
• 
Device Evaluation (pace threshold, sense 
amplitude, impedance, RV shock impedance, LV 
Phrenic Stimulation threshold) 
• 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
• 
Evaluation of Beeper function 
• 
Document if polymorphic or monomorphic VT/VF 
episodes requiring therapy, are present 
• 
Documentation of spontaneous VT/VF episode(s) 
by PRM strips, as applicable: 
◼ ‘Selected Episodes Report’ (counters and 
EGMs required) 
◼ ‘Arrhythmia Logbook’ 
• 
Printout of ‘Quick Notes’ Report 
• 
Assessment of MR scan image quality 
Retain at center 
Adverse Events 
Retain at center 
MR scanner DICOM dump/ report file including items 
such as scan sequence settings and durations as well as 
calculated scan metrics such as whole body average 
SAR. 
The DICOM file must contain both images and scan 
sequence data. 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
Save All 
Retain the original at the center 
and submit a copy to Boston 
Scientific 
Text in table that is italicized is recommended 
 Study Completion 
Subjects will be followed until completion of the Implant + 1 Year Visit. The individual 

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subject will finish the study when he/she completes the Implant + 1 Year Visit. 
Note: Phase I is completed when all the subjects finish MRI + 1 Month Visit, and the data 
will be summarized to support product CFDA registration. 
13. Statistical Considerations 
 Primary Endpoints 
13.1.1. Primary Safety Endpoint: MR Scan-Related ImageReady System Complication 
Free Rate  
The primary safety endpoint of the MR ICD study will be assessed for all subjects who 
undergo any portion of the study-required MR scan sequences. Safety will be confirmed by 
evaluating the MR scan related ImageReady System complication-free rate (CFR) between 
the MR Scan and the MRI Visit + 1 Month. 
For the purpose of this endpoint, a MR scan-related ImageReady System complication will 
be defined as those complications that are related to the MR scan and ImageReady System. 
All complications that the site reports as related to the MR scan and ImageReady System will 
be adjudicated by an external committee for relation to the MR scan. Complications that are 
determined to be associated with the MR scan will be considered MR scan-related 
complications and count against this endpoint. Complication is defined as serious adverse 
event or permanent loss of device functions (i.e. pacing or defibrillation). 
The performance goal of the primary safety endpoint for the ENABLE MRI study (MR scan 
related ImageReady System complication free rate) was 90%. There is no hypothesis testing 
in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary 
safety endpoint event may occur. Descriptive statistics will be conducted for the endpoint 
events. 
The data set for the primary safety endpoint will include all subjects who undergo the 
study-required MR scan sequences (scan sequences initiated, whether complete or nor). The 
time window for MRI + 1 Month visit is 30±7 days post MR scan, so it will capture events 
within at least 23 days post scan. In this small sample size study, missing data will be 
excluded. 

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13.1.2. Primary Effectiveness Endpoint 1: Pre-MR Scan vs. 1 Month Post-MR Scan RV 
shocking impedance 
The normal RV shocking impedance measured by the system should be≤200 Ohm, 
with >200 Ohm considered abnormal. The primary effectiveness endpoint 1 is defined as that 
the average RV shocking impedance is >200 Ohm 1 month post scan, while it is ≤ 200 Ohm 
before scan. 
There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up 
to 2 failed cases of primary effectiveness endpoint 1 occur. 
The data set for the primary effectiveness endpoint 1 will only include subjects who undergo 
the study-required MR scan and complete all the sequences, and will not include subjects that 
meet any of the following exclusions: 
• 
Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• 
Fails to meet labeled MRI Conditions of Use 
• 
Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
The time window for MRI + 1 Month visit is 30±7 days post MR scan, so it will capture 
events within at least 23 days post scan. In this small sample size study, missing data will be 
excluded. 
13.1.3. Primary Effectiveness Endpoint 2: Pre-MR Scan vs. 1 Month Post-MR Scan RV 
Pacing Threshold at 0.5 ms 
Subjects that have an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR 
Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a 
primary effectiveness endpoint 2 event. 
The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no 
hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed 
cases of primary effectiveness endpoint 2 occur. 
The data set for the primary effectiveness endpoint 2 will only include subjects who undergo 
the study-required MR scan and complete all the sequences, and will not include subjects that 
meet any of the following exclusions: 

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• 
Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• 
Fails to meet labeled MRI Conditions of Use 
• 
Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
The time window for MRI + 1 Month visit is 30±7 days post MR scan, so it will capture 
events within at least 23 days post scan. In this small sample size study, missing data will be 
excluded. 
13.1.4. Primary RV Effectiveness Endpoint 3: Pre-MR scan vs. 1 Month Post-MR Scan 
RV Sensed Amplitude 
Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month 
Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary 
effectiveness endpoint 3 event. 
The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no 
hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed 
cases of primary effectiveness endpoint 3 occur. 
The data set for the primary effectiveness endpoint 3 will only include subjects who undergo 
the study-required MR scan and complete all the sequences, and will not include subjects that 
meet any of the following exclusions: 
• 
Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• 
Fails to meet labeled MRI Conditions of Use 
• 
Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
• 
Average RV sensed amplitude <5mV pre-MR scan 
The time window for MRI + 1 Month visit is 30±7 days post MR scan, so it will capture 
events within at least 23 days post scan. In this small sample size study, missing data will be 
excluded. 

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13.1.5. Primary Effectiveness Endpoint 4: Pre MR Scan- vs. 1 Month Post-MR Scan LV 
Pacing Threshold at 0.5 ms 
Subjects that have an increase in average pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR 
Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a 
primary effectiveness endpoint 4 event. 
The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no 
hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed 
cases of primary effectiveness endpoint 4 occur. 
The data set for the primary effectiveness endpoint 4 will only include subjects who undergo 
the study-required MR scan and complete all the sequences, and will not include subjects that 
meet any of the following exclusions: 
• 
Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• 
Fails to meet labeled MRI Conditions of Use 
• 
Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
The time window for MRI + 1 Month visit is 30±7 days post MR scan, so it will capture 
events within at least 23 days post scan. In this small sample size study, missing data will be 
excluded. 
13.1.6. Primary Effectiveness Endpoint 5: Pre-MR scan vs. 1 Month Post-MR Scan LV 
Sensed Amplitude 
Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month 
Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary 
effectiveness endpoint 5 event. 
The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no 
hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed 
cases of primary effectiveness endpoint 5 occur. 
The data set for the primary effectiveness endpoint 5 will only include subjects who undergo 
the study-required MR scan and complete all the sequences, and will not include subjects that 
meet any of the following exclusions: 

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• 
Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• 
Fails to meet labeled MRI Conditions of Use 
• 
Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
• 
Average LV sensed amplitude <5mV pre-MR scan 
The time window for MRI + 1 Month visit is 30±7 days post MR scan, so it will capture 
events within at least 23 days post scan. In this small sample size study, missing data will be 
excluded. 
 Ancillary Assessments 
The ancillary endpoints are not formal endpoints. 
13.2.1. Assessment of RV and LV Impedances 
The changes in RV and LV impedances pre-MR scan versus 1 Month post-MR scan (MRI 
Visit and MRI + 1 Month Visit) will be presented in the study report. 
13.2.2. Assessment of RA lead measurements 
The changes in RA lead measurements including pacing thresholds, sensed amplitudes and 
impedances, between pre- and 1 Month post-MR scan measurements will be presented in the 
study report. 
13.2.3. Assessment of VT/VF post MR scan 
The detection time (first elapsed time), therapy given and conversion result, shocking 
impedance (if applicable) for post MR scan VT/VF episodes will be presented in the study 
report. 
13.2.4. Assessment of Programming the MRI Protection Mode 
The following information will be summarized for both study-related MR scans and 
medically necessary MR scans: 
• 
Duration of the PG in the MRI Protection Mode 
• 
Time from the start of the MRI Protection Mode to the start of the MR scan 
• 
Time from the end of the MR scan to exiting the MRI Protection Mode 

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13.2.5. Assessment of Image Artifacts for non-medically necessary MR scans 
MR image quality scores will be presented in the study report. 
 Sample Size 
The MR ICD study is a small sample size study without any formal hypothesis testing. 
Twenty subjects (10 with ICD and 10 with CRT-D) will be enrolled. It is assumed that the 
attrition should not be more than 2 cases in each group, so that at least 8 ICD subjects (at 
least 1 single chamber and 1 dual chamber ICD) and 8 CRT-D subjects shall undergo 
required MR scan and complete all the sequences. Sample size might be expanded to meet 
this assumption. 
 General Statistical Methods 
13.4.1. Control Bias 
Selection of patients will be made from the Investigator’s usual patient load. All patients 
meeting the eligibility criteria and having signed the ICF will be eligible for enrollment in the 
study. An independent Clinical Events Committee (CEC) will determine the MR 
Scan-related ImageReady System complications. The study will be conducted in 
approximately 5 sites and one single site may not enroll more than 10 subjects generally. 
13.4.2. Data Analyses 
The MR ICD study is a multi-center, prospective, single –arm study. There is no formal 
hypothesis testing. Descriptive statistics will be conducted for the endpoint events. Please 
refer to section13.1for endpoint assessment. 
13.4.3. Data Set, Subgroups and Missing Data 
The data set for the safety endpoint will include all subjects who undergo the study-required 
MR scan sequences (scan sequences initiated, whether complete or nor). The data set for the 
effectiveness endpoint will only include subjects who undergo the study-required MR scan 
and complete all the sequences, and will not include subjects that meet any of the following 
exclusions: 
• 
Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• 
Fails to meet labeled MRI Conditions of Use 

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• 
Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit MRI 
Subjects whose average RV sensed amplitude <5mV pre-MR scan will also be excluded for 
primary effectiveness endpoint 3 assessment, and subjects whose average LV sensed 
amplitude <5mV pre-MR scan will also be excluded for primary effectiveness endpoint 5 
assessment. 
There is no formal subgroup analysis in the MR ICD study, however, descriptions may be 
grouped on study site, subject sex, device type (single chamber ICD, dual chamber ICD and 
CRT-D), etc. 
The primary endpoints for the MR ICD study are comparisons between MRI Visit and the 
MRI + 1 Month Visit, absence of either comparator will be missing data for that endpoint.  
Missing data will be excluded for endpoint assessment in this small sample size MR ICD 
study. 
13.4.4. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan. Changes from the planned statistical 
methods after performing the analyses will be documented in the clinical study report along 
with a reason for the deviation. 
14. Data Management 
 Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system. 
The clinical database will reside on a production server hosted by EDC System. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by the sponsor or its representative. The associated RAVE software and database have been 
designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 

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The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data discrepancies. 
Manual and/or automatic queries will be created in the EDC system and will be issued to the 
site for appropriate response. Site staff will be responsible for resolving all queries in the 
database. 
 Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain, at the 
investigative site, all essential study documents and source documentation that support the 
data collected on the study subjects in compliance with ICH/GCP guidelines and China 
relative regulations. Documents must be retained for 10 years after complete of the clinical 
study, or longer according to the individual site’s requirement. BSC must retain relative 
clinical study documents till discontinuation of clinical use of the products. 
BSC should inform the Principal Investigators and investigation sites the time period 
required to maintain these documents. The Principal Investigator or his/her designee will take 
measures to ensure that these essential documents are not accidentally damaged or destroyed. 
If for any reason the Principal Investigator or his/her designee withdraws responsibility for 
maintaining these essential documents, custody must be transferred to an individual who will 
assume responsibility and BSC must receive written notification of this custodial change. 
Sites are required to inform Boston Scientific in writing where paper or electronic files are 
maintained in case files are stored off site and are not readily available. 
15. Amendments 
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals of the 

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revised clinical investigational plan by Ethics Committee must be obtained prior to 
implementation. 
16. Deviations  
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing EC of any major deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using EDC. Sites may also be 
required to report deviations to the EC, per local guidelines and government regulations. 
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
Deviations will be classified by BSC according to the following definitions:  
• 
Type A - Deviation to protect the life or physical well-being of a patient in an 
unforeseen emergency.  
• 
Type B - Deviation based on medical judgment.  
• 
Type C - Deviation due to misunderstanding of protocol requirements.  
• 
Type D - Deviation due to a situation that is beyond control.  
• 
Type E - Deviation due to an oversight, error or protocol non-compliance. 
Also, a major PD is a protocol deviation that directly or potentially disrupts the study 
progress (i.e., the study design, study data and results can be compromised), OR a protocol 
deviation that compromises the safety and welfare of study participants. A minor PD is a 
protocol deviation that does not disrupt study progress (i.e., the study design, study data and 

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results will not be compromised), AND does not compromise the safety and welfare of study 
participants. 
17. Device Accountability 
The investigational devices shall be securely maintained, controlled, and used only in this 
clinical study. The current BSC processes will be used to track subjects and device 
allocations during the study. 
The sponsor shall keep records to document the physical location of all investigational 
devices from shipment of investigational devices from BSC or designated facility/equipment 
to the investigation sites until return or disposal. 
Records shall be kept by the investigation sites to document the physical location and 
conditions of storage of all investigational devices. 
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices, which shall include the 
following: 
• Date of receipt 
• Identification of each investigational device (unique code) 
• Expiry date, as applicable 
• Date or dates of use 
• Subject identification 
• Manufacture date of investigational device 
• Batch number of investigational device 
• Date on which the investigational device was returned, if applicable 
• Date of return of unused, expired, or malfunctioning investigational devices, if 
applicable. 

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18. Compliance 
 Statement of Compliance 
This study will be conducted in accordance with ISO 14155:2011 Clinical Investigation of 
Medical Devices for Human Subjects-Good Clinical Practice, the relevant parts of the ICH 
Guidelines for Good Clinical Practice, ethical principles that have their origins in the 
Declaration of Helsinki, and China laws and regulations. The study shall not begin until the 
required approval/favorable opinion from the EC and/or regulatory authority has been 
obtained, if appropriate. Any additional requirements imposed by the EC or regulatory 
authority shall be followed, if appropriate. 
 Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation plan, 
ISO 14155:2011, ethical principles that have their origins in the Declaration of Helsinki, any 
conditions of approval imposed by the reviewing EC, and prevailing local and/or country 
laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following. 
• 
Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• 
Prior to beginning the study, sign the Investigator Brochure Signature Page (if applicable) 
and Protocol Signature page documenting his/her agreement to conduct the study in 
accordance with the protocol. 
• 
Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 

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• 
Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• 
Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all 
clinical-investigation-related records are retained per requirements. 
• 
Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• 
Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. Provide 
analysis report, which includes the causality assessed by both investigator and BSC and 
decision on study continuance, to EC per local and/or country requirements. 
• 
Report to sponsor, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE and potential USADE or UADE. 
• 
Report to the EC and regulatory authorities any SAEs and device deficiencies that could 
have led to a SADE and potential USADE or UADE, if required by the national 
regulations or this protocol or by the EC, and supply BSC with any additional requested 
information related to the safety reporting of a particular event. Provide all required 
source documents related to a death event to BSC and the EC per local requirements. 
• 
Maintain the device accountability records and control of the device, ensuring that the 
investigational device is used only by authorized/designated users and in accordance 
with this protocol and instructions/directions for use. 
• 
Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• 
Allow and support regulatory authorities and the EC when performing auditing 
activities. 

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• 
Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local EC requirements. 
• 
Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• 
Inform the subject of the nature and possible cause of any adverse events experienced. 
• 
As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the investigational device when it is used/operated by the subject. 
• 
Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• 
Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
• 
Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• 
Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together 
with identification and compliance information for concomitant treatment measures 
(contact address and telephone numbers shall be provided). 
• 
Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• 
Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• 
Ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation. 

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• 
Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
18.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training and adequate supervision of those to whom tasks are delegated. The 
investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study. 
 Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational site will provide to the sponsor 
documentation verifying that their EC is registered or that registration has been submitted to 
the appropriate agency, as applicable according to national/regulatory requirements. 
A copy of the written EC and/or competent authority approval of the protocol (or permission 
to conduct the study) and Informed Consent Form, must be received by the sponsor before 
recruitment of subjects into the study and shipment of investigational product/equipment. 
Prior approval must also be obtained for other materials related to subject recruitment or 
which will be provided to the subject. 
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by local/country or EC requirements. Copies of the Investigator’s reports and the EC 
continuance of approval must be provided to the sponsor. 
 Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including Contract Research Organization (CRO) will have access to these 
confidential records. Authorized regulatory personnel have the right to inspect and copy all 
records pertinent to this study. Study data collected during this study may be used by BSC 
for the purposes of this study, publication, and to support future research and/or other 

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business purposes. All data used in the analysis and reporting of this study will be without 
identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations.  Boston Scientific may use subjects’ health information to 
conduct this research, as well as for additional purposes, such as overseeing and improving 
the performance of its device, new medical research and proposals for developing new 
medical products or procedures, and other business purposes. Information received during 
the study will not be used to market to subjects; subject names will not be placed on any 
mailing lists or sold to anyone for marketing purposes. 
18.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during implant, testing required by the protocol, 
and follow-ups. Support may include HCP training, addressing HCP questions, or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices (including 
programmers, analyzers, and other support equipment). 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment during implant or follow-up, assist with the conduct of testing 
specified in the protocol, and interact with the subject to accomplish requested activities. 
Typical tasks may include the following. 
• 
Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment 
• 
Performing lead diagnostic testing using a Pacing System Analyzer or programmer to 
obtain pacing and sensing thresholds and impedance measurements 
• 
Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• 
Assisting with the collection of study data from Pacing System Analyzers, programmers, 
and other equipment 

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• 
Entering technical data on technical source form as long as the responsible investigator 
verifies and signs the completed worksheet  
• 
Print out programming reports directly from the clinician programmer and provide 
original to clinical site as source documentation 
• 
Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or their 
delegated site staff and the subject.  
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
• 
Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• 
Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following. 
• 
Practice medicine 
• 
Provide medical diagnosis or treatment to subjects 
• 
Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the investigator 
• 
Independently collect critical study data (defined as primary or secondary endpoint data) 
• 
Enter data in electronic data capture systems or on paper case report forms 
 Insurance 
China BSC will provide insurance coverage for subjects in the study. If any study related 
health injury occurs and a site is held responsible for its compensation, where required, BSC 
will assume the responsibility, except in the case that damages are incurred due to deviation 
of the protocol, intentional or serious negligence at the site. 

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19. Monitoring 
Monitoring will be performed during the study, according to the study Monitoring Plan, to 
assess continued compliance with the current, approved protocol/amendment(s) and 
applicable regulations. In addition, the monitor verifies that informed consent is obtained 
from all enrolled study subjects, study records are adequately maintained, that data are 
reported in a satisfactory manner with respect to timeliness, adequacy, and accuracy, and that 
the Investigator continues to have sufficient staff and facilities to conduct the study safely 
and effectively. Pre-defined thresholds for protocol deviation and compliance once met or 
exceeded, can also trigger increased monitoring frequency and/or the implementation of 
corrective action plans at clinical sites. For the  MR China Study, source documents include, 
at a minimum but not limited to, the ICF; patient medical records, including nursing records 
and catheterization laboratory records; diagnostic imaging records; laboratory results; reports 
of SAEs; and device accountability logs. Data documented in the eCRF relevant to device 
deficiencies, relationship of AE to study device(s), index procedure, and antiplatelet 
medication; and anticipatedness assessment of ADEs, may be considered source data for the 
study.  
The Investigator/institution guarantees direct access to original source documents (electronic 
or paper) by BSC personnel, their designees, and appropriate regulatory authorities. In the 
event that the original medical records cannot be obtained for a subject that is seen by a 
non-study physician at a non-study institution, photocopies of the original source documents 
must be made available for review. Photocopies of original source documents related to 
SAEs (from either the study site or a non-study institution, if applicable) must also be made 
available for submission to BSC. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 

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20. Potential Risks and Benefits 
 Anticipated Adverse Events 
Subjects participating in this study are subject to the same risks shared by all patients 
undergoing implantation of a defibrillation system. Table 20-1 list the potential adverse 
events for pulse generator and/ or lead system implants. 
Table 20-1 Potential Adverse Events for Pulse Generator and/ or Lead System Implants 
Potential Adverse Events for Implantation of a Pulse Generator and/ or Lead 
System 
Adverse 
reaction 
to 
procedure 
(e.g., 
bradycardia, 
general, 
respiratory, 
hypotension) 
Lead dislocation 
Air embolism 
Lead fracture 
Allergic reaction 
Lead insulation breakage or abrasion 
Allergic reaction to the contrast media 
Lead perforation 
Arterial damage with subsequent stenosis 
Lead tip deformation and / or breakage 
Bleeding 
Local tissue reaction 
Bradycardia 
Loss of capture 
Breakage/failure of the implant instruments 
Low amplitude VF signals 
Cardiac tamponade 
Malignancy or skin burn due to 
fluoroscopic radiation 
Chronic nerve damage 
Myocardial Infarction 
Component failure 
Myocardial necrosis 
Conductor coil fracture 
Myocardial trauma (e.g., irritability, 
injury, tissue damage, valve damage) 
Coronary venous spasm 
Myopotential sensing 
Death 
Oversensing / undersensing 
Electrolyte imbalance/ dehydration 
Pacemaker-mediated tachycardia (PMT) 
Elevated thresholds 
Pericardial rub, effusion 
Erosion 
Pneumothorax 
Excessive fibrotic tissue growth 
Post-shock rhythm disturbances 
Extracardiac stimulation (muscle/ nerve 
stimulation) 
Prolonged exposure to fluoroscopic 
radiation 
Fluid accumulation 
Pulse generator and/or lead migration 
Foreign body rejection phenomena 
Renal failure from contrast media used 
to visualize coronary veins 
Formation of hematomas or seromas 
Shunting current during defibrillation 
with internal or external paddles 

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Heart block 
Syncope 
Hemorrhage 
Tachyarrhythmias, which include 
acceleration of arrhythmias and early, 
recurrent atrial fibrillation 
Hemothorax 
Thrombus, thromboemboli 
Inability to defibrillate or pace 
Valve damage 
Inappropriate therapy (shocks, ATP or 
pacing)  
Vasovagal response 
Incisional pain 
Venous occlusion 
Insulating myocardium during defibrillation 
internal or external paddles 
Venous trauma (e.g., perforation, 
dissection, erosion) 
Incomplete lead connection with pulse 
generator 
Worsening heart failure 
Infection including endocarditis 
 
 
Subjects may develop psychological intolerance to a pulse generator system and may 
experience the following: dependency, depression, fear of premature battery depletion, fear 
that shocking capability may be lost, imagined shocking/fear of shocking while conscious, 
and fear of device malfunction. 
 Risks Associated with Study Devices 
Risks Associated with Study Devices are listed in Table 20-1. There are no additional risks 
associated with the study devices compared with other commercial products in the market. 
 Risks Associated with Participation in the Clinical Study 
Subjects in the MR ICD Study will have the added risk of an MR scan. Potential adverse 
events associated with an MR scan are minimized by assuring that the subject meets the MRI 
Conditions of Use. MRI scanning of patients when the Conditions of Use are met could result 
in the following potential adverse events, as included in the BSC MRI Tech Guide: 
• 
Arrhythmia induction 
• 
Bradycardia 
• 
Patient death 
• 
Patient discomfort due to slight movement or heating of the device 
• 
Side effects of pacing at a fixed high rate such as competition with intrinsic rhythms 
and arrhythmias. Competitive pacing may increase the rate of pacing induced 

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arrhythmia until the device is reprogrammed. 
• 
Syncope 
• 
Worsening heart failure 
MRI scanning of patients when the Conditions of Use are NOT met could result in the 
following potential adverse events, as included in the BSC MRI Technical Guide: 
• 
Arrhythmia induction 
• 
Bradycardia 
• 
Damage to the pulse generator and/or leads 
• 
Erratic pulse generator behavior 
• 
Inappropriate pacing, inhibition of pacing, failure to pace 
• 
Increased rate of lead dislodgement (within six weeks of implant or revision of 
system) 
• 
Irregular or intermittent capture or pacing 
• 
Loss of defibrillation therapy 
• 
Pacing threshold changes 
• 
Patient death 
• 
Patient discomfort due to movement or heating of the device 
• 
Physical movement of pulse generator and/or leads 
• 
Sensing changes 
• 
Syncope 
• 
Worsening heart failure 
**Note: It is important to note that the risks listed in this section may lead to the subject 
requiring a partial or full pacing system replacement. 
20.3.1. Beeper 
The Beeper may no longer be audible following an MRI scan. 
The beeper provides: (1) an audible patient warning when potential therapy failure is 
detected between scheduled PG checks with a device-following physician, and (2) audible 

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feedback to clinical personnel regarding the state of the PG such as, current tachycardia 
mode and when charging for shock therapy. An inaudible beeper results in an increase of the 
associated risk. An in-clinic follow-up schedule of every three months is strongly 
recommended to monitor device performance. Refer to the BSC MRI Technical Guide for 
more information on the Beeper. 
Situations that will no longer trigger audible Beeper tones once the device is programmed 
into MRI Protection Mode: 
Programmable Beeper options 
• 
Beep During Capacitor Charge 
• 
Beep When Lead Impedance Out-of-Range 
• 
Beep when Explant is Indicated 
Non-Programmable Beeper options 
• 
Application of the patient magnet over the 
pulse generator in certain situations (e.g. 
confirming Tachycardia Mode) 
• 
Battery capacity depleted (End of Life (EOL)) 
• 
Battery fault alert 
• 
High voltage fault alert 
• 
Reversion of the PG to Safety Core Operation 
• 
PG Reset 
 
 Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
 Anticipated Benefits 
Subjects may not receive any benefit from participating in this study. However, medical 
science and future patients may benefit from their participation in this clinical study. 

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 Risk to Benefit Rationale 
There are no unacceptable residual risks/intolerable risks and all applicable risks have been 
addressed through the provision of appropriate Directions for Use (DFU). Evaluation of the 
risks and benefits that are expected to be associated with use of the ImageReady System 
demonstrate that when used under the conditions intended, the benefits associated with use of 
the System should outweigh the risks. 
21. Safety Reporting 
 Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• All Serious Adverse Events 
• All Investigational Device Deficiencies  
• Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any AE event required by the protocol, experienced by the study subject after informed 
consent and once considered enrolled in the study (as defined in study subject classification 
section), whether during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity of 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of ONE (1) specific SAE (see Table 21-1 for AE 
definitions). 
Refer to Section 20 for the known risks associated with the study device(s). 

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 Definitions and Classification 
Adverse event definitions are provided in Table 21-1. Administrative edits were made on the 
definition of serious adverse event from ISO 14155and MEDDEV 2.7/3. 
Table 21-1 Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
 
 
Any untoward medical occurrence, unintended disease or injury, 
or any untoward clinical signs (including an abnormal laboratory 
finding) in subjects, users or other persons, whether or not 
related to the investigational medical device.  
NOTE 1: This includes events related to the investigational 
medical device or comparator. 
NOTE 2: This definition includes events related to the 
procedures involved. 
NOTE 3: For users or other persons, this definition is restricted 
to events related to the investigational medical device.  
Adverse Device Effect 
(ADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse event related to the use of an investigational medical 
device 
NOTE 1: This includes any adverse event resulting from 
insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation, 
or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use 
error or intentional abnormal use of the investigational 
medical device. 
Serious Adverse Event 
(SAE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Note: This definition meets the reporting objectives  and  
requirements  of  ISO 14155  and  MEDDEV 2.7/3. 
Adverse event that: 
a) Led to death, 
b) Led to  serious deterioration in the health of the subject as 
defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, or 
3) in-patient hospitalization or prolongation of existing 
hospitalization , or 
4) medical or surgical intervention to prevent 
life-threatening illness or injury or permanent 
impairment to a body structure or a body function 

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Term 
Definition 
c) Led to fetal distress, fetal death, or a congenital abnormality or 
birth defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or 
a procedure required by the clinical investigational plan, without 
a serious deterioration in health, is not considered a serious 
adverse event.  
Serious Adverse Device 
Effect (SADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
Unanticipated Adverse 
Device Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with, 
a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary 
plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects.   
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
 
 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the current 
version of the risk analysis report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is 
an effect which by its nature, incidence, severity or outcome has 
been identified in the risk analysis report. 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
An inadequacy of an investigational medical device related to its 
identity, quality, durability, reliability, safety or performance. 
This may include malfunctions, use error, or inadequacy in the 
information supplied by the manufacturer. 
 
Complication is defined as serious adverse event or permanent loss of device functions (i.e. 
pacing or defibrillation). 

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 Relationship to Study Devices 
The Investigator must assess the relationship of the AE to the study device or procedure. See 
criteria in Table 21-2: 

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Table 21-2 Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
Classification 
Description 
Not Related 
Relationship to the device or procedures can be excluded when: 
- the event is not a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
- the event has no temporal relationship with the use of the 
investigational device or the procedures; 
- the serious event does not follow a known response pattern to the 
medical device (if the response pattern is previously known) and is 
biologically implausible; 
- the discontinuation of medical device application or the reduction of 
the level of activation/exposure - when clinically feasible – and 
reintroduction of its use (or increase of the level of 
activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be affected 
by the device or procedure; the serious event can be attributed to 
another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, 
drug, treatment or other risk factors); 
- the event does not depend on a false result given by the investigational 
device used for diagnosis, when applicable; harms to the subject are not 
clearly due to use error; 
- In order to establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the serious event. 
Unlikely Related 
The relationship with the use of the device seems not relevant and/or 
the event can be reasonably explained by another cause, but additional 
information may be obtained. 
Possibly Related 
The relationship with the use of the investigational device is weak but 
cannot be ruled out completely. Alternative causes are also possible 
(e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment). Cases were relatedness 
cannot be assessed or no information has been obtained should also be 
classified as possible. 
Probably Related 
The relationship with the use of the investigational device seems 
relevant and/or the event cannot reasonably explained by another cause, 
but additional information may be obtained. 
Causal 
Relationship 
The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 

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Classification 
Description 
- the event is a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
- the event has a temporal relationship with investigational device 
use/application or procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical 
device (if the response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or increase 
of the level of activation/exposure), impact on the serious event (when 
clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment) have 
been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the investigational device 
used for diagnosis, when applicable; 
- In order to establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedures and the serious event. 
 
 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 21-3. 
Table 21-3 Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect  
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 24 hours of first 
becoming aware of the event  
• Reporting required through 
the end of the study 
Serious Adverse Event 
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 24 hours of first 
becoming aware of the event  
• Reporting required through 
the end of the study 
Provide all relevant source 
• When 
documentation 
is 

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Event Classification 
Communication Method  
Communication Timeline  
documentation of the 
reported event 
available 
Serious Adverse Device 
Effects 
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 24 hours of first 
becoming aware of the event  
• Reporting required through 
the end of the study 
Provide all relevant source 
documentation of the 
reported event 
• When 
documentation 
is 
available 
Device Deficiencies 
(including but not limited to 
failures, malfunctions, and 
product nonconformities) 
Note: Any Investigational 
Device Deficiency that 
might have led to a serious 
adverse event if a) suitable 
action had not been taken or 
b) intervention had not been 
made or c) if circumstances 
had been less fortunate is 
considered a reportable 
event. 
Complete AE eCRF page 
with all available new and 
updated information. 
• Within 1 business day of first 
becoming aware of the event  
• Reporting required through 
the end of the study 
Adverse Event including 
Adverse Device Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness 
and relationship to the 
device. 
• Within 10 business days after 
becoming 
aware 
of 
the 
information  
• Reporting required through 
the end of the study 
 
 Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and labeling errors) will be documented and reported to BSC. If 
possible, the device(s) should be returned to BSC for analysis. Instructions for returning the 

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investigational device(s) will be provided in Device Management Plan. If it is not possible to 
return the device, the investigator should document why the device was not returned and the 
final disposition of the device. Device failures and malfunctions should also be documented 
in the subject’s medical record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as adverse events. However, if there is an adverse 
event that results from a device failure or malfunction, that specific event would be recorded 
on the appropriate eCRF. 
Any Device Deficiency that might have led to a serious adverse event if a) suitable action 
had not been taken or b) intervention had not been made or c) if circumstances had been less 
fortunate is considered a reportable event, and should be reported according to Table 21-3. 
 Reporting to Regulatory Authorities / ECs / Investigators 
BSC is responsible for reporting adverse event and device deficiency information to all 
participating Principal Investigators and regulatory authorities, as applicable. 
The Principal Investigator is responsible for informing the EC, and regulatory authorities of 
UADE and SAE as required by local/regional regulations.  
BSC shall notify all participating study centers if SAEs/SADEs occur which imply a possible 
increase in the anticipated risk of the procedure or use of the device or if the occurrence of 
certain SAEs/SADEs demands changes to the protocol or the conduct of the study in order to 
further minimize the unanticipated risks. 
According to China local reporting requirements, Boston Scientific Corporation will report 
all SAEs  and device deficiencies that could lead to SAEs to the local regulatory authorities 
within 5 business days of BSC first becoming aware of the event, and notify all participating 
investigators/sites and ECs in a timely manner. 
BSC, Investigator, or Site must notify the EC of UADEs, USADEs, SADEs, SAEs, Device 
Deficiencies and/or other CEC events as applicable according to local reporting requirements. 
A copy of the Investigator’s reports and other relevant reports (if applicable) to the EC must 
be provided to BSC in accordance with local requirements. 

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 Subject Death reporting 
A subject death during the study should be reported to Boston Scientific as soon as possible 
and, in any event, within 24 hours of site notification. The site’s EC must be notified of any 
deaths in accordance with that site’s EC policies and procedures. 
Notification of death must include a detailed narrative (death letter) that provides detailed 
information describing the circumstances surrounding the death. A death narrative in the 
local language is acceptable, if accompanied by a translation in English. The details listed 
below should be addressed in the death narrative, in order for BSC to understand the 
circumstance surrounding the death: 
• 
Date and time of death 
• 
Place death occurred 
• 
Immediate cause of death 
• 
Rhythm at the time of death, if known (include any available documentation) 
• 
Whether the death was related to the pulse generator, lead/catheter, clinical 
investigation, procedure, or patient condition 
• 
Whether or not the death was witnessed 
• 
Device status and/or activity at the time of death (device recipients only – pacing 
and defibrillation, active or inactive) 
• 
Whether the patient had worsening heart failure 
• 
Any other circumstances surrounding the death 
• 
Approximate time interval from the initiating event to death (temporal course) items 
to consider include, but are not limited to: information regarding last time subject 
was seen by investigator, last office visit, etc. 
• 
Investigator or sub-investigator signature and date 
Also submit the following documentation, if the patient expired in the hospital: 
• 
A copy of the medical records for that admission (e.g., H & P, consults, test results, 
operative reports, and/or progress notes from the hospital chart) 
• 
Death certificate (if available) 
• 
Autopsy report (if applicable) 
• 
If the patient expired outside of the hospital (e.g., home): 
• 
A copy of the most recent clinic visit (if not already submitted to Boston Scientific) 
• 
Death certificate (if available) 

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Whenever possible, the IPG should be interrogated. Investigational leads and related Boston 
Scientific RM system components (e.g., IPGs) should be removed intact and returned 
promptly to Boston Scientific RM for analysis. The Clinical Events Committee (CEC) must 
review information regarding subject deaths. 
22. Informed Consent 
Subject participation in this clinical study is voluntary. If a subject is unable to make the 
decision to participate in this clinical investigation (e.g. seriously ill or unconscious subject, 
mentally ill person, mentally handicapped person), the legally authorized representative 
might sign the ICF. In such case, the subject shall also be informed about the clinical study 
within his/her ability to understand. An independent witness shall present through a 
supervised informed consent process and sign the ICF if a subject or legally authorized 
representative is unable to read or write. The Investigator is responsible for ensuring that 
Informed Consent is obtained prior to the use of any investigational devices, study-required 
procedures and/or testing, or data collection. 
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of ICH/GCP, the Declaration of Helsinki, ISO 14155, any applicable national 
regulations by CFDA, and local Ethics Committee and/or Regulatory authority body, as 
applicable. The ICF must be approved by the site’s EC, or central EC, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s EC.  Any modification requires acceptance from BSC prior to use of the 
form.  The ICF must be in a language understandable to the subject and if needed, BSC will 
assist the site in obtaining a written consent translation. Translated consent forms must also 
have EC approval prior to their use.  Privacy language shall be included in the body of the 
form or as a separate form as applicable. 
The process of obtaining Informed Consent includes: 
• 
be conducted by the Principal Investigator or designee authorized to conduct the 
process, 

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• 
include a description of all aspects of the clinical study that are relevant to the 
subject’s decision to participate throughout the clinical study, 
• 
avoid any coercion of or undue influence of subjects to participate, 
• 
not waive or appear to waive subject’s legal rights, 
• 
use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• 
provide ample time for the subject to consider participation and ask questions if 
necessary, 
• 
ensure important new information is provided to new and existing subjects 
throughout the clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative, 
and by the investigator and/or an authorized designee. If a legal representative signs, the 
subject shall be asked to provide informed consent for continued participation as soon as 
his/her medical condition allows. The original signed ICF will be retained by the site and a 
copy of the signed and dated document and any other written information must be given to 
the person signing the form. 
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements. Any violations of the informed consent process must be 
reported as deviations to the sponsor, EC and local regulatory authorities, as appropriate. 
If new information becomes available that can significantly affect a subject's future health and 
medical care, that information shall be provided to the affected subject(s) in written form via a 
revised ICF or, in some situations, enrolled subjects may be requested to sign and date an 
addendum to the ICF. In addition to new significant information during the course of a study, 
other situations may necessitate revision of the ICF, such as if there are amendments to the 
protocol, a change in Principal Investigator, administrative changes, or following annual 
review by the EC. The new version of the ICF must be approved by the EC. Boston Scientific 
approval is required if changes to the revised ICF are requested by the center’s EC. The EC 
will determine the subject population to be re-consented. 

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The investigator shall inform the subject that even if he/she gives consent to participate in the 
study, test(s) results might prove the subject’s illegibility. The subject’s informed will be 
recorded in a screen sheet, including but not limited to the reason of screen failure. 
23. Committees 
Safety Monitoring Process 
To promote early detection of safety issues, the BSC Safety team and its delegated CRO 
Safety team will provide review, process, monitor and evaluation of the safety events defined 
in the study-specific safety plan. Success of this program requires dynamic collection of 
unmonitored data as soon as the event is reported. During regularly scheduled monitoring 
activities, clinical research monitors will support the dynamic reporting process through their 
review of source document and other data information. The BSC Medical Safety group 
includes physicians with expertise in relative field and with the necessary therapeutic and 
subject matter expertise to evaluate and classify the events into the categories outlined above. 
Clinical Events Committee 
A Clinical Events Committee (CEC) will be used in this study. A CEC is an independent 
group of individuals with pertinent expertise, including Cardiology, which reviews and 
adjudicates important endpoints and relevant adverse events reported by study investigators. 
The CEC will review a safety event dossier, which may include copies of subject source 
documents provided by study sites, and adjudicate study endpoint related clinical events.. 
The responsibilities, qualifications, membership, and committee procedures of the CEC are 
outlined in the CEC charter. 
For the purpose of the study primary safety endpoint, an MR scan-related ImageReady 
System complication will be defined as those complications that are related to the MR scan 
and ImageReady System. All complications that the site reports as related to the MR scan 
and ImageReady System will be adjudicated by an external committee for relation to the MR 
scan. Complications that are determined to be associated with the MR scan will be 
considered MR scan-related complications and count against this endpoint. 

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Complication is defined as serious adverse event or permanent loss of device functions (i.e. 
pacing or defibrillation). 
24. Suspension or Termination 
Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects.  Investigators, associated ECs, and regulatory authorities, 
as applicable, will be notified in writing in the event of study termination. 
Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• 
Important information that impacts the progression of the study (e.g. safety or 
production performance). 
• 
Regulatory authorities decide to terminate the study. 
• 
A decision on the part of Boston Scientific to suspend or discontinue development 
of the device. 
• 
An enrollment rate far below expectation that prejudices the conclusion of the study. 
Note: According to requirements in section21, even if the MR ICD study is terminated, 
subjects with study device(s) shall be followed up for AE, SAE, SADE and device deficiency, 
which are to be assessed and reported. 
There is no hypothesis testing or interim analysis in this study. If the study is terminated 
prematurely, the already collected data shall be described according to section13. 
Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval 
Any investigator, or EC in the MR ICD study may discontinue participation in the study or 
withdrawal approval of the study, respectively, with suitable written notice to Boston 
Scientific. Investigators, associated ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of these occurrences. 

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Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
EC and regulatory authorities, as applicable, will be notified. Detailed information on how 
enrolled subjects will be managed thereafter will be provided.  
In the event an EC terminates participation in the study, participating investigators, 
associated ECs, and regulatory authorities, as applicable, will be notified in writing. Detailed 
information on how enrolled subjects will be managed thereafter will be provided by Boston 
Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
investigational product to Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 
Criteria for Suspending/Terminating a Study Site 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
site at any time after the study initiation visit if no subjects have been enrolled  for a period 
beyond 3 months after site initiation, or if the site has multiple or severe protocol 
deviations/noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of site participation, all study devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The EC and regulatory authorities, as applicable, will be notified. 
All subjects enrolled in the study at the site will continue to be followed till end of the study. 
The Principal Investigator at the site must make provision for these follow-up visits unless 
BSC notifies the investigational site otherwise. 

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According to section21, all subjects with study device(s) shall be followed up for AEs, which 
are to be assessed and reported. The Principal Investigator at the site must make provision for 
these follow-up visits unless BSC notifies the investigational site otherwise. 
25. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC will submit study 
results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific Corporation adheres to the Contributorship Criteria set forth in 
the Uniform Requirements of the International Committee of Medical Journal Editors 
(ICMJE; http://www.icmje.org). In order to ensure the public disclosure of study results in a 
timely manner, while maintaining an unbiased presentation of study outcomes, BSC 
personnel may assist authors and investigators in publication preparation provided the 
following guidelines are followed. 
• 
All authorship and contributorship requirements as described above must be 
followed. 
• 
BSC involvement in the publication preparation and the BSC Publication Policy 
should be discussed with the Coordinating Principal Investigator(s) and/or 
Executive/Steering Committee at the onset of the project. 
• 
The First and Senior authors are the primary drivers of decisions regarding 
publication content, review, approval, and submission. 
26. Reimbursement and Compensation for Subjects 
Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations. 

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Compensation for Subject’s Health Injury 
Boston Scientific Corporation will purchase an insurance policy to cover the cost of potential 
health injury for study subjects, and if required by applicable law. 
27. Bibliography 
1. Nazarian S, Hansford R, Roguin A, et al. A prospective evaluation of a protocol for 
magnetic resonance imaging of patients with implanted cardiac devices. ANN INTERN 
MED 2011;155:415-24. 
2. Russo RJ, Costa HS, Silva PD, et al. Assessing the Risks Associated with MRI in Patients 
with a Pacemaker or Defibrillator. N Engl J Med 2017;376:755-64. 
3. ASTM Standard F2503-08, “Standard Practice for Marking Medical Devices and Other 
Items for Safety in the Magnetic Resonance Environment” ASTM International, West 
Conshohocken, PA, 2008, DOI: 10.1520/F2503-08, www.astm.org.. 
4. 中华医学会心电生理和起搏分会, 中华医学会心血管病学分会, 中国医师协会心律
学专业委员会植入型心律转复除颤器治. 植入型心律转复除颤器治疗的中国专家共
识. 中华心律失常学杂志 2014;18:242-53. 
5. 张澍, 黄德嘉, 华伟, et al. 心脏再同步治疗慢性心力衰竭的建议(2013 年修订版). 中
华心律失常学杂志 2013;17:247-61. 
6. Wolf SM, Lawrenz FP, Nelson CA, et al. Managing incidental findings in human subjects 
research: analysis and recommendations. J LAW MED ETHICS 2008;36:219-48, 211. 
7. Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document for safe MR practices: 
2007. AJR Am J Roentgenol 2007;188:1447-74. 
28. Abbreviations 
Abbreviations are shown in Table 28-1. 
Table 28-1 Abbreviations 
Abbreviations Term 
Chinese 
ADE 
Adverse Device Effect 
器械不良反应 
AE 
Adverse Event 
不良事件 
BSC 
Boston Scientific 
波士顿科学 

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CFDA 
China Food and Drug Administration 
中国食品和药品监督管理局 
CFR 
Complication-free rate  
无并发症率 
CRF 
Case Report Form 
电子病例报告表 
EC 
Ethics Committee 
伦理委员会 
ECG 
Electrocardiogram 
心电图 
eCRF 
Electronic Case Report Form 
电子病例报告表 
EDC 
Electronic data capture 
电子数据采集 
FDA 
Food and Drug Administration 
食品和药品监督管理局 
GCP 
Good Clinical Practice 
临床试验质量管理规范 
ICF 
Informed Consent Form 
知情同意书 
IDE 
Investigational Device Exemptions 
研究器械豁免 
IPG 
Implantable Pulse Generator 
植入性脉冲发生器 
LOC 
Loss of Capture 
失夺获 
MRI 
Magnetic Resonance Imaging 
磁共振成像 
ms 
Milliseconds 
毫秒 
mV 
Millivolts 
毫伏 
MV 
Minute Ventilation 
分钟通气量 
RA 
Right atrium/ atrial 
右心房 
RF 
Radio-frequency 
射频 
RV 
Right ventricle/ ventricular 
右心室 
SADE 
Serious Adverse Device Effect 
严重器械不良反应 
SAE 
Serious Adverse Event 
严重不良事件 
T 
Tesla 
特斯拉 
UADE 
Unanticipated Adverse Device Effect 
非预期的器械不良反应 
USADE 
Unanticipated Serious Adverse Device 
Effect 
非预期的严重器械不良反应 
29. MR Scan Sequences Protocol 
This section includes the scan sequences for use in the ENABLE MRI Study. 
Background 
The MR scan sequences have been selected for their clinical relevance and their intensity as 
regards the RF and time-varying gradient fields the implanted system will be exposed to 
during the scan duration. The scan sequences selected are intended for utilization during a 

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Page 88 of 90 
 
 
 
total of approximately 30 minutes of imaging (the total duration of time in the bore will be 
approximately one hour). 
Conditional Labeling 
Key aspects of the initial MR Conditional labeling being sought by Boston Scientific for the 
ImageReady System, which affect the types of scan sequences are: 
• 
1.5 T, closed-bore MRI machines only 
• 
No anatomical scan restrictions (e.g. no isocenter scan exclusion zone) 
• Scans up to Normal Operating Mode SAR limits are allowed 
The scan sequences, target anatomical locations and positions of the subjects in the scan are 
selected in order to challenge and evaluate the safety of the ImageReady System for these 
key aspects of the MR Conditional labeling. 
Notes Regarding the MR Scan 
1. During the course of the imaging, the subject will be located in two unique positions: 
a. In order to maximize RF exposure, RF-intensive scan sequences will be run with the 
thoracic spine anatomical region centered within the bore. This will result in the 
implanted defibrillation system being located near the center of the scanner RF 
transmit coil, where the transmitted RF fields are strongest. 
b. In order to maximize gradient exposure, gradient-intensive scan sequences will be 
run with the lumbar spine anatomical region centered within the bore. This will 
result in the implanted pacing system being located near the edges of the scanner 
gradient coils where gradient fields are strongest. 
2. External coils are not to be used, in order to prevent unnecessary complexity in moving 
the subject between the two locations in the bore. To maintain consistency across scans, 
the body coil in the MRI scanner is to be used for all scan sequences. 
3. All DICOM files from the scans must be saved as part of the study data. 
4. Notes for RF-intensive scan sequences 
a. A portion of the scan images obtained via the FSE sequences will be evaluated for 
the impact of image artifact near the implanted system on the overall clinical utility 
of the images. As such, a wide field of view (FOV) should be used, such as 40-48 

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Confidential                                 MR ICD Protocol，92096984,  Rev/AC 
Page 89 of 90 
 
 
 
cm depending on subject size, in order to image across the torso and include the PG 
in the image. Additionally, a frequency matrix size of 512 pixels should be used. 
b. FSE sequences are to be T2-weighted, which are sequences that normally result in a 
high whole body average specific absorption rate (SAR). Utilize scan sequence 
parameters that would normally be used in clinical practice. All sequences in the 
RF-intensive section must only be run at Normal Operating Mode. Sequence 
parameters may be altered in order to increase whole body average SAR , such as (in 
addition to the settings mentioned in 4a) increasing the turbo factor or number of 
slices while ensuring the duration of the scan sequences is maintained, but must not 
exceed Normal Operating Mode SAR limits. 
c. If any individual sequence in the RF-intensive sequences is not available or cannot 
be run, that sequence must be abandoned and the durations of one or more of the 
other scan sequences increased such that the overall duration of the RF-intensive 
scanning is maintained. 
5. The suggested duration of all sequences are guidelines for the MR Technician running 
the scan. Variations from the suggested duration for each of the individual sequences are 
not to be considered as deviations from the protocol provided the overall scan durations 
for the RF-intensive and gradient-intensive scan regimens are adhered to (e.g. 11.5 
minutes minimum and a maximum of 14 minutes for the RF intensive scan regimen, 17 
minutes minimum and a maximum of 21 minutes for the gradient -intensive scan 
regimen). Active scan time must not be greater than 35 minutes. Pre-scan time does not 
count towards the required duration. 
Table 29-1 Scan Sequence Protocol 
Scan Sequence* 
Suggested Duration per 
Scan Sequence 
Anatomical 
Region 
Centered in 
Bore 
Scanning Mode 
Requirements 
RF-Intensive (See note 4 above) 
Sagittal Fast Spin Echo T2 
3.5 - 4 minutes 
Thoracic spine 
Must not exceed Normal 
Operating Mode SAR limits 
Axial Fast Spin Echo T2 
3.5 - 4 minutes 
Coronal Fast Spin Echo T2 
3.5 - 4 minutes 
Single Shot Turbo Spin 
Echo 
1 - 1.5 minutes 

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Required sub-total = 11.5 - 
14 minutes 
 
Gradient-Intensive 
 
 
 
Axial Diffusion EPI 
2.5 - 3 minutes 
Lumbar spine 
 
Axial Perfusion EPI 
2.5 - 3 minutes 
Sagittal Diffusion EPI 
2.5 - 3 minutes 
3D Plane Localizer 
30 seconds 
Axial 3D TOF MRA 
5 - 5.5 minutes 
Coronal 3D Bolus MRA 
1 - 1.5 minutes 
Axial Fast Spin Echo T2 
Flair 
3 - 3.5 minutes 
 
Required sub-total = 17 - 
21 minutes 
 
 
Maximum scan time= 35 
minutes 
 
 
* Scan sequence names may be slightly different depending on scanner manufacturer. 

                                                   Form/Template 90702637_Rev/VerAI     
                              MR ICD Protocol，92096984, Rev/AC   
 
CONFIDENTIAL                                                                                                                             
 
 
 
Statistical Analysis Plan 
 
 An Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)   
 MR ICD CHINA 
Study Reference # C2082 
Version AB 
11FEB2020 
  
 
 
CONFIDENTIAL 
DO NOT COPY OR DISTRIBUTE WITHOUT WRITTEN PERMISSION 
 
 
 
 
 
 
APPROVALS (Check/Complete one below): 
 
 Approvals are captured electronically 
 
 An electronic system for capturing approvals is not being used for this study; wet 
signatures are captured below: 
 
__________________________________________________________ 
 
___________________ 
Lead Biostatistician – [Sunil Babu, Sr.Biostatistician] 
 
Date (dd-mon-yyyy) 
__________________________________________________________ 
 
___________________ 
Clinical Project/Trial Manager – [Zhiwei Gu, Clinical Trial Manager] 
 
Date (dd-mon-yyyy) 
__________________________________________________________ 
 
___________________ 
Medical Director – [Zhiyu Zeng, Medical Director] 
 
Date (dd-mon-yyyy) 

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Revision History 
Version AB Latest Version 
Original Release Version : AA 
 
SAP Template version : 92096984, Rev/Ver AC 
 
Document 
Revision 
Number/Date 
Section 
Change 
Reason for Change 
Version AA/ 
28AUG2019 
None 
None 
Original Release 
Version AB/ 
11FEB2020 
• Section : 4.1 
• Section 5.1.2 
• Section 5.1.3 
• Section 7.5 
• 1.Protocol 
summary 
• Section 3.3 
• Included Attempt and 
Partial Implant population 
definitions 
• Removed the plot based on 
complication free rate 
• Updated Ancillary 
measurement summary for 
VT/VF episodes and 
included listing of the 
Arrhythmia Logbook 
details  
• SAS code for Clopper-
Pearson  
• Updated CFDA to National 
Medical Products 
Administration (NMPA) 
• Including population 
definitions in accordance to 
protocol, ir-respective of 
considering the populations 
for analysis 
• Due to less time point 
duration the plot been 
excluded from analysis 
• Ancillary measurements, SAS 
code and NMPA update 
suggested by sponsor 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. 
PROTOCOL SUMMARY ................................................................................................... 4 
1.1 
Study design: ................................................................................................................... 4 
1.2 
Study objective: ............................................................................................................... 4 
1.3 
Number of sites and patients and enrollment .................................................................. 4 
1.4 
Description of study population ...................................................................................... 4 
1.5 
Description of device(s) including model numbers used in the study ............................. 4 
1.6 
Study procedure ............................................................................................................... 6 
1.7 
Follow-up schedule ......................................................................................................... 6 
1.8 
Study duration ................................................................................................................. 6 
2. 
INTRODUCTION ................................................................................................................ 7 
3. 
ENDPOINT ANALYSIS ...................................................................................................... 7 
3.1 
Primary Safety Endpoint ................................................................................................. 7 
3.2 
Primary Efficacy Endpoint .............................................................................................. 8 
3.3 
Ancillary Assessments................................................................................................... 10 
3.4 
Hypotheses .................................................................................................................... 10 
3.5 
Sample Size ................................................................................................................... 11 
3.6 
Statistical Methods ........................................................................................................ 11 
4. 
GENERAL STATISTICAL METHODS ......................................................................... 11 
4.1 
Analysis Sets ................................................................................................................. 11 
4.2 
Control of Systematic Error/Bias .................................................................................. 12 
4.3 
Number of Subjects per Investigative Site .................................................................... 12 
5. 
DATA ANALYSES ............................................................................................................. 12 
5.1 
Endpoints/Measurements analysis ................................................................................. 12 
5.1.1 
Primary efficacy endpoint analysis: ...................................................................... 13 
5.1.2 
Primary safety endpoint analysis: .......................................................................... 13 
5.1.3 
Ancillary Assessments ........................................................................................... 14 
5.2 
Interim Analyses ............................................................................................................ 14 
5.3 
Subgroup Analyses ........................................................................................................ 14 
5.4 
Justification of Pooling .................................................................................................. 14 
5.5 
Multivariable Analyses .................................................................................................. 15 
5.6 
General considerations .................................................................................................. 15 
5.7 
Other Statistical considerations ..................................................................................... 15 
5.7.1 
Patient disposition/status ....................................................................................... 15 
5.7.2 
Baseline and Demographic analysis ...................................................................... 15 
5.7.3 
Procedure Characteristics and performance .......................................................... 15 
5.7.4 
Analysis of Adverse and Serious adverse events .................................................. 16 
5.7.5 
Protocol Deviations ............................................................................................... 17 
5.7.6 
Device Deficiencies ............................................................................................... 17 
5.8 
Changes to Planned Analyses ........................................................................................ 18 
6. 
Validation ............................................................................................................................ 18 
7. 
Programming Considerations ............................................................................................ 18 
7.1 
Statistical Software ........................................................................................................ 18 
7.2 
Format of Output ........................................................................................................... 18 
7.3 
Methods for Handling Missing Data ............................................................................. 18 
7.4 
Rules and Definitions .................................................................................................... 19 
7.5 
SAS code for Clopper-Pearson ...................................................................................... 19 
 

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1. PROTOCOL SUMMARY 
The study is conducted in accordance to the requirement of global multi-center study, 
ENABLE MRI (NCT02652481), on MR conditional systems including DYNAGEN and 
INOGEN. MR ICD (Magnetic Resonance - Implanted Cardiac Devices) protocol is based 
on ENABLE MRI study. National Medical Products Administration (NMPA) requires 
certain clinical trial in China to support the approval of ImageReady™ MR conditional 
defibrillation system. The ImageReady MR Conditional Defibrillation System included in 
the MR ICD Clinical Study, here to forward referred to as the ImageReady System, 
consists of DYNAGEN and INOGEN series pulse generators, RELIANCE 4-FRONT 
series defibrillation leads, ACUITY X4 series left ventricle (LV) leads, and INGEVITY 
series pacing leads for right atrium (RA). 
1.1 Study design:  
This is a prospective, multi-center, single-arm, pre-market study 
1.2 Study objective: 
The study objective is to evaluate the safety and effectiveness of ImageReady™ MR 
conditional defibrillation system in Chinese population, to support the regulatory 
approval by NMPA. 
1.3 Number of sites and patients and enrollment 
Subjects in this trial will not be randomized. Subjects will be considered enrolled into 
the MR ICD study at the time of informed consent form execution. All subject 
enrollments will be counted against the enrollment ceiling for the study.  
 
This study will be conducted at up to 5 centers in China.  Data will be collected at 20 
patients. All participating patients will sign the informed consent form approved at the 
participating center per local requirements. Generally, one individual center may not 
enroll more than 10 subjects. Investigational sites will be notified when the enrollment 
goal is close to being reached and once enrollment is complete. 
1.4 Description of study population 
Subjects enrolled in the MR ICD study shall be selected from the investigators general 
patient population indicated for an ICD or CRT-D implantation. The Investigator is 
responsible for screening potential subjects and selecting those who meet the eligibility 
criteria for the study as described in Inclusion and Exclusion criteria. 
1.5 Description of device(s) including model numbers used in the study 
The ImageReady MR Conditional Defibrillation System included in the MR ICD 
Clinical Study, here to forward referred to as the ImageReady System, consists of 
DYNAGEN and INOGEN series pulse generators, RELIANCE 4-FRONT series 

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defibrillation leads, ACUITY X4 series left ventricle (LV) leads, and INGEVITY series 
pacing leads for right atrium (RA). DYNAGEN and INOGEN pulse generators, 
belonging to the new generation products. DYNAGEN will be used as the only pulse 
generator in MR ICD study, while lead selection will be decided mainly by 
investigators based on subjects’ anatomy and clinical practice. This study intention is to 
label the ImageReady MR Conditional Defibrillation System models “MR Conditional” 
as defined by the American Society for Testing and Materials (ASTM) 3, when used as 
a system and in accordance with labeled Conditions of Use. 
 
The below table give the details of ImageReady MR Conditional Defibrillation System 
Components 
  
Component 
Name 
Model 
Features 
Pulse Generators 
DYNAGEN 
D150 
Single chamber ICD, DF4  
D152 
Dual chamber ICD, DF4  
G158 
CRT-D, DF4, IS4  
INOGEN 
D140 
Single chamber ICD, DF4  
D142 
Dual chamber ICD, DF4  
G148 
CRT-D, DF4, IS4  
Defibrillation 
Leads 
RELIANCE 4-FRONT 
active fixation, single coil, Gore coating 
0692  
59cm  
0693  
64cm  
0657  
70cm  
RELIANCE 4-FRONT 
active fixation, dual coil, Gore coating 
0695  
59cm  
0696  
64cm  
0658  
70cm  
LV leads 
ACUITY X4 straight 
4671  
86cm  
4672  
95cm  
ACUITY X4 spiral S 
4674  
86cm  
4675  
95cm  
ACUITY X4 spiral L 
4677  
86cm  
4678  
95cm  
RA leads 
INGEVITY 
passive fixation, J type 
7735  
45cm  
7736  
52cm  
INGEVITY 
active fixation, straight 
7740  
45cm  
7741  
52cm  
7742  
59cm  
INGEVITY 
passive fixation, straight 
7731  
52cm  
7732  
59cm  

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1.6 Study procedure 
Data will be collected from subjects upon enrollment into the study, at implant, and at 
pre-discharge. Subjects will have an MR scan at 6-9 weeks post-implant, or at least 6 
weeks after any required surgical interventions to the ImageReady System (labeled as 
MRI Visit). Subsequently, there will be a clinic follow up at MRI + 1 Month Visit, and 
recommended clinic follow up every 3 months post MR scan. Subjects will also be 
followed at 1-year post-implant. The MR ICD study is composed of two phases. Phase 
I is completed when all the subjects finish MRI + 1 Month Visit, which starts Phase II 
till 1-year post implantation. The first Every 3-month visit will occur 90 ± 14 days after 
MRI visit. Subsequent Every 3-month follow-up visits will be scheduled every three 
months (90 days ± 14 Days) from the previous scheduled study follow-up. Phase I is 
expected to last about 9 months after first subject enrollment, and the whole study is 
expected to last about 20 months after first subject enrollment. 
1.7 Follow-up schedule 
After First MRI visit the patient visit include: 
a. MRI + 3month visit 
b. MRI + 6month visit 
c. MRI + 9month visit 
d. Implant+ 1-Year visit 
e. Medically necessary MRI 
f. Any Additional visits 
 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system. The individual subject will finish the study when he/she completes the Implant 
+ 1 Year Visit. 
1.8 Study duration 
Phase I is expected to last about 9 months after first subject enrollment, by when all the 
subjects will have finished MRI +1 Month Visit. Phase II continues to all the subjects 
complete one-year follow-up post-implant, and the whole study is expected to last 
about 20 months after first subject enrollment. Statistical analysis reports are also 
generated based on Phase I and Phase II study durations. (See section 5.1) 
 
 
 
 
 
 

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2. INTRODUCTION 
This statistical analysis plan addresses the planned analyses for the MR ICD CHINA- 
Clinical Trial based on the latest version of protocol dated May 1, 2018, Version AC. 
Specified analyses may be used for scientific presentations and/or manuscripts, and 
regulatory submissions.  
 
Subjects depending on the implanted leads will be performed : 
a. Manual Right Atrial Threshold Test 
b. Manual Right Ventricular Threshold Test 
c. Manual Left Ventricular Threshold Test 
 
Upon the completion of Implant procedure, Pre-discharge Visit will occur either on the 
same day as the ImageReady System implant procedure, a minimum of 3 hours after 
pocket closure, or up to 72 hours after the implant procedure. Then MRI visits and other  
follow-up visits will occur. 
 
The primary safety analysis will be based on MR Scan-related ImageReady System 
Complication-Free Rate between the MR Scan and the MRI + 1 Month Visit. The 
primary effectiveness endpoints based on Abnormal increase and decrease in RV and LV 
on impedance, threshold and amplitude.  Ancillary components RA & IV assessments, 
VT/VF episodes assessments and Image Artifacts assessments will be analyzed as well. 
These analyses are more elaborately detailed in the below endpoint analysis. 
 
3. ENDPOINT ANALYSIS 
The primary safety endpoint analysis is based on MR Scan-Related ImageReady 
System Complication Free Rate.    
 
 
3.1 Primary Safety Endpoint 
i. Primary Safety Endpoint: The primary safety endpoint of the MR ICD study 
will be assessed for all subjects who undergo any portion of the study-
required MR scan sequences. Safety will be confirmed by evaluating the 
MR scan related ImageReady System complication-free rate (CFR) 
between the MR Scan and the MRI Visit + 1 Month. There is no hypothesis 
testing in the MR ICD study, and it can be considered reasonable if up to 2 
failed cases of primary safety endpoint event may occur. Descriptive 
statistics will be conducted for the endpoint events with 95% CI. The time 
window for MRI + 1 Month visit is 30±7 days post MR scan, so it will 

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capture events within at least 23 days post scan. Missing data will be 
excluded. 
3.2 Primary Efficacy Endpoint 
There are 5 primary effectiveness endpoints on the Abnormal increase and decrease 
in RV and LV components for shocking impedance, pacing threshold and sensed 
amplitude. There is no hypothesis testing in the MR ICD study, and it can be 
considered reasonable upon the failed cases of primary effectiveness endpoint 
occur. 
i. Primary Effectiveness Endpoint 1: Pre-MR Scan vs. 1 Month Post-MR Scan 
RV shocking impedance: 
The data set for the primary effectiveness endpoint 1 will only include 
subjects who undergo the study-required MR scan and complete all the 
sequences, and will not include subjects that meet any of the following 
exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 
Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the 
MRI + 1 Month Visit 
The normal RV shocking impedance measured by the system should 
be≤200 Ohm, with >200 Ohm considered abnormal. The primary 
effectiveness endpoint 1 is defined as that the average RV shocking 
impedance is >200 Ohm 1-month post scan, while it is ≤ 200 Ohm before 
scan.      
ii. Primary Effectiveness Endpoint 2: Pre-MR Scan vs. 1 Month Post-MR Scan 
RV Pacing Threshold at 0.5 ms: 
The data set for the primary effectiveness endpoint 2 will only include 
subjects who undergo the study-required MR scan and complete all the 
sequences, and will not include subjects that meet any of the following 
exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 
Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the 
MRI + 1 Month Visit 
The primary effectiveness endpoint 2 is defined as ‘an increase in average 
pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 

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Month follow-up will be considered as success’, otherwise it’s a failure ( 
event).     
iii. Primary Effectiveness Endpoint 3: Pre-MR scan vs. 1 Month Post-MR Scan 
RV Sensed Amplitude: 
The data set for the primary effectiveness endpoint 3 will only include 
subjects who undergo the study-required MR scan and complete all the 
sequences, and will not include subjects that meet any of the following 
exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 
Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the 
MRI + 1 Month Visit 
• Average RV sensed amplitude <5mV pre-MR scan 
The primary effectiveness endpoint 3 is defined as ‘an increase in average 
pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 
Month follow-up will be considered as success’, otherwise it’s a failure 
(event).    
iv. Primary Effectiveness Endpoint 4: Pre-MR Scan- vs. 1 Month Post-MR Scan 
LV Pacing Threshold at 0.5 ms: 
The data set for the primary effectiveness endpoint 4 will only include 
subjects who undergo the study-required MR scan and complete all the 
sequences, and will not include subjects that meet any of the following 
exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 
Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the 
MRI + 1 Month Visit 
The primary effectiveness endpoint 4 is defined as ‘increase in average 
pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 
Month follow-up will be considered a success’, otherwise it’s a failure 
(event).   
v. Primary Effectiveness Endpoint 5: Pre-MR scan vs. 1 Month Post-MR Scan 
LV Sensed Amplitude: 
The data set for the primary effectiveness endpoint 5 will only include 
subjects who undergo the study-required MR scan and complete all the 

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sequences, and will not include subjects that meet any of the following 
exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 
Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the 
MRI + 1 Month Visit 
• Average LV sensed amplitude <5mV pre-MR scan 
3.3 Ancillary Assessments 
The ancillary endpoints are not formal endpoints 
• Changes in RV and LV impedances pre-MR scan versus 1 Month post-MR 
scan (MRI Visit and MRI + 1 Month Visit) assessed for RV and LV 
Impedances 
• Changes in RA lead measurements including pacing thresholds, sensed 
amplitudes and impedances, between pre- and 1 Month post-MR scan 
measurements  assessed for RA lead measurements 
• The detection time (first elapsed time), therapy given and conversion result, 
shocking impedance (if applicable) assessed for post MR scan VT/VF 
episodes. For a VT/VF episode, there might be no therapy, ATP or Shock 
therapy. Only shock therapy will have a shocking impedance, while shock for 
VT/VF might be very few in this small sample study. Data collected from 
Arrhythmia Logbook Report used for Assessment of VT/VF post MR scan  
and only VT/VF episodes from Arrhythmia  log book considered for analysis. 
Detection time, Therapy given are summarized based on subject total episodes 
from visit and shocking impedance summarized based on subjects.  
• The following information will be summarized for both study-related MR 
scans and medically necessary MR scans: 
o Duration of the PG in the MRI Protection Mode 
o Time from the start of the MRI Protection Mode to the start of the MR 
scan 
o Time from the end of the MR scan to exiting the MRI Protection Mode 
• MR image quality scores will be presented in study report for assessment of 
Image Artifacts for non-medically necessary MR scans 
 
3.4 Hypotheses 
There is no formal hypothesis planned for this study. The individual performance 
goal is sort of hypothesis, to decide the performance status of each endpoint.   

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3.5 Sample Size  
The MR ICD study is a small sample size study without any formal hypothesis 
testing. Twenty subjects (10 with ICD and 10 with CRT-D) will be enrolled. It is 
assumed that the attrition should not be more than 2 cases in each group, so that at 
least 8 ICD subjects (at least 1 single chamber and 1 dual chamber ICD) and 8 CRT-
D subjects shall undergo required MR scan and complete all the sequences. Sample 
size might be expanded to meet this assumption. 
3.6 Statistical Methods 
The procedure success rate for both primary safety and efficacy endpoints  will be 
summarized descriptively. Categorical variables will be tabulated with frequencies, 
percentages and 95% confidence intervals. Continuous variables will be tabulated 
with mean, median, standard deviation, minimum, maximum, and 95% confidence 
interval of the mean. 
4. GENERAL STATISTICAL METHODS 
4.1 Analysis Sets 
 The definition of analysis datasets planned for the study detailed below: 
 
a. Intent population - includes all subjects who undergo the study-required 
MR scan sequences (scan sequences initiated, whether complete or nor). 
The Intent-to-Treat group will be analyzed for safety data and effectiveness 
specific to stent placement/removability.  
b. Implant population - is the subset of the ITT subjects that will only include 
subjects who undergo the study-required MR scan and complete all the 
sequences, and will not include subjects that meet any of the following 
exclusions: 
o Has a medically necessary scan between implant and the MRI + 1 
Month Visit 
o Fails to meet labeled MRI Conditions of Use 
o Experiences a lead-related complication between MRI Visit and the 
MRI + 1 Month Visit MRI 
Subjects whose average RV sensed amplitude <5mV pre-MR scan will also 
be excluded for primary effectiveness endpoint 3 assessment and subjects 
whose average LV sensed amplitude <5mV pre-MR scan will also be 
excluded for primary effectiveness endpoint 5 assessment. 
c. Attempt - Attempt refers to a subject who has had the lead(s) and/or PG 
introduced into the body but is not successfully implanted with any portion 
of the ImageReady System during the implant procedure. Attempt subjects 

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must be followed 30 ± 7 days post-attempted ImageReady System implant 
to assure there are no associated adverse events, or to assure the resolution 
of any adverse events associated with the attempted ImageReady System 
implant, then withdrawn from the study. 
d. Partial Implant - Partial Implant refers to a subject who is implanted with 
a component of the ImageReady System (lead or pulse generation) during 
the implant procedure but does not end up with a complete ImageReady 
System. They shall not receive the protocol required MR Scan according to 
the BSC MRI Technical Guide. Partial Implant subjects must be followed 
30 ± 7 days post- ImageReady System implant to assure there are no 
associated adverse events, or to assure the resolution of any adverse events 
associated with the ImageReady System implant, then withdrawn from the 
study. 
However, the results for the populations been analyzed when the subjects 
status been categorized in Attempt and Partial Implant populations and 
based on the sponsor requirements. 
4.2 Control of Systematic Error/Bias 
There is no randomization schema assigned in the study. Selection of patients will be 
made from the Investigator’s usual patient load. All patients meeting the eligibility 
criteria and having signed the ICF will be eligible for enrollment in the study. An 
independent Clinical Events Committee (CEC) will determine the MR Scan-related 
ImageReady System complications. Consecutively eligible subjects should be enrolled 
into the study to minimize selection bias. 
4.3 Number of Subjects per Investigative Site 
The study will be conducted in approximately 5 sites and one single site may not enroll 
more than 10 subjects.  
5. DATA ANALYSES 
5.1 Endpoints/Measurements analysis 
Statistical endpoint and other analysis report generated based on study design phases, 
which as detailed in study duration section. Phase I include the statistical report till 9 
months study duration and Phase II statistical report for complete study including all 
follow-ups and additional visits information. A set of additional tables and listings will 
be provided based on final available data lock, compared to initial Phase I generated 
report. However, this analysis plan created in context to final statistical report. 
 

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                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
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Page 13 of 19                                 
 
5.1.1 Primary efficacy endpoint analysis: 
The primary effectiveness endpoints are defined as ‘a success  based on the 
specified criteria conditions earlier’, otherwise it’s a failure (event) .   
All the 5- primary endpoints are based on Implant population, 
o Pre-MR Scan vs. 1 Month Post-MR Scan RV shocking impedance 
o Pre-MR Scan vs. 1 Month Post-MR Scan RV Pacing Threshold at 
0.5 ms 
o Pre-MR scan vs. 1 Month Post-MR Scan RV Sensed Amplitude 
o Pre-MR Scan- vs. 1 Month Post-MR Scan LV Pacing Threshold at 
0.5 ms 
o Pre-MR scan vs. 1 Month Post-MR Scan LV Sensed Amplitude 
are summarized descriptively with counts and percentages presenting 95% 
Clopper-Pearson confidence interval with two-sided exact binomial 
confidence bound at 95% will be presented to anticipate that the endpoint 
success is more than the lower bound of the confidence limits.  
The time window for MRI + 1 Month visit is 30±7 days post MR scan, so it 
will capture events within at least 23 days post scan for all the endpoints 
and Missing data will not be considered in the denominator part while 
deriving confidence limits and performance goals. 
5.1.2 Primary safety endpoint analysis: 
The primary safety endpoint of the MR ICD study will be assessed for all 
subjects who undergo any portion of the study-required MR scan 
sequences. Safety will be confirmed by evaluating the MR scan related 
ImageReady System complication-free rate (CFR) between the MR Scan 
and the MRI Visit + 1 Month. This endpoint is analyzed based on Implant  
population. Counts and percentages presenting 95% Clopper-Pearson 
confidence interval with two-sided exact binomial confidence bound at 
95%.  
Complications that are determined to be associated with the MR scan will 
be considered MR scan-related complications and count against this 
endpoint. Complication is defined as serious adverse event or permanent 
loss of device functions (pacing/defibrillation).  
All the primary efficacy endpoint and safety endpoint been summarized 
presenting 95% Clopper-Pearson confidence interval with two-sided exact 
binomial confidence made for both Intent and Implant study populations. If 
subject’s status been categorized to either Attempt or Partial Implant, then 
the results been presented for both these populations as well. 

Boston Scientific Corporation 
                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
  CONFIDENTIAL 
 
Page 14 of 19                                 
 
5.1.3 Ancillary Assessments 
We are also analyzing the ancillary assessments for pacing threshold, Pulse 
width, sensed amplitude and pacing impedance for RA, RV and LV 
components. The ancillary endpoints are not formal endpoints; however, 
we present results based on Ancillary Assessments requirements. A listing 
will be provided with all the details provided from the Arrhythmia  log 
book. 
All the categorical response of the measurements  summarized using counts 
and percent. The continuous parameters including time variables presented 
with mean, standard deviation with counts and minimum and maximum 
values. is based on Implant population  
We are also presenting the plots in connection with ancillary assessments 
for pacing threshold, Pulse width, sensed amplitude and pacing impedance 
for RA, RV and LV components.  
o A mean plot generated based on the duration and pacing threshold by 
RA, RV and LV components by separate panel.  
o A mean plot generated based on the duration and Pulse width by RA, 
RV and LV components by separate panel.  
o A mean plot generated based on the duration and Sensed amplitude by 
RA, RV and LV components by separate panel.  
o A mean plot generated based on the duration and Pacing impedance  by 
RA, RV and LV components by separate panel. 
5.1.4 Interim Analyses  
No formal interim analyses are planned for this study. If the study is 
terminated prematurely, the already collected data shall be described 
according 
5.1.5 Subgroup Analyses 
No subgroup analyses are planned for this study. There is no formal 
subgroup analysis in the MR ICD study, however, descriptions may be 
grouped on study site, subject sex, device type (single chamber ICD, dual 
chamber ICD and CRT-D), etc. 
5.1.6 Justification of Pooling 
This study will be conducted under a common protocol for each 
investigational site with the intention of pooling the data for analyses. 
Every effort will be made to promote consistency in study execution at 
each investigational site. 

Boston Scientific Corporation 
                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
  CONFIDENTIAL 
 
Page 15 of 19                                 
 
5.1.7 Multivariable Analyses 
No multivariate methodology included for the primary, secondary or other 
endpoints 
5.2    General considerations 
All continuous measurements will be summarized descriptively at each visit by 
treatment using observed data. Endpoints that are analysed untransformed and 
endpoints that are not formally analysed are summarized by the arithmetic mean, 
standard deviation (SD), minimum and maximum value with counts (N). Mean and 
SDs rounded to one decimal, minimum, maximum is presented exact as per the data 
values. 
5.3   Other Statistical considerations  
All the statistical analysis for other tables other than endpoint results will be generated 
based on Implant population only. However, depending on the results and sponsor 
requirements the Implant population results will be performed. 
5.3.1 Patient disposition/status 
Number of subjects enrolled by investigator and site will be summarized 
with counts and percent based on Implant population.  
A table based on Subject Disposition of Clinical Follow-up Compliance 
will be provided at MRI Visit +1Month visits after device implant.  A 
table supported to present the counts based on the enrollments per site will 
be provided. 
If any deaths happened, a supporting listing based on deaths will be 
provided with related to study device and study procedure, with date of 
death and duration of days from device implant. 
5.3.2 Baseline and Demographic analysis 
Baseline characteristics with Arrhythmia and Cardiac disease history, 
physical examinations summarized at screening or baseline visit. 
Continuous measurements will be summarized descriptively and 
categorical measurements with counts and percent.   
 
5.3.3 Procedure Characteristics and performance 
Procedure evaluation summary for Atrial Fibrillation., RA, RV & LV lead 
measurements and PNS threshold  with New Episode of polymorphic and 
Image Artifacts measurement are summarized. Device Information like 
Pulse generator, Defibrillation Lead & LV Lead are summarized for 
Implant populations at Implant procedure, Pre-Discharge, MNS Pre - Post 
MR Scan visits, Pre MR-Scan Visit, Post MR Scan Visit & MRI Visit+1 
Month procedure, MRI Visit+ 3-month, MRI  Visit+ 6-month, MRI  

Boston Scientific Corporation 
                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
  CONFIDENTIAL 
 
Page 16 of 19                                 
 
Visit+ 9-month visits and Implant+1-year visits. However, the results will 
be summarized only for the above available timepoint visits. 
 
A comprehensive listing based on MRI information by visits is presented 
by subject with MRI protection mode, Time of MR scan initiation and 
completion, exiting MRI protection and radiologist scores are presented. 
 
▪ A listing based on pacing threshold LEAD (RA/RV/LV) for each 
subject with site  
▪ A listing based on Sensed Amplitude LEAD (RA/RV/LV) for each 
subject with site  
▪  A listing based on Pacing Impedance LEAD (RA/RV/LV) for 
each subject with site  
▪ A listing based on Shocking Impedance LEAD (RA/RV/LV) for 
each subject with site  
will be presented based on available analysis time points including 
Implant procedure, Pre-Discharge, MNS Pre - Post MR Scan visits, 
Pre MR-Scan Visit, Post MR Scan Visit & MRI Visit+1 Month 
procedure, MRI Visit+ 3-month, MRI  Visit+ 6-month, MRI  Visit+ 9-
month visits and Implant+1-year visits. All the above listings are based 
on Implant populations.   
 
A summary table for all medications  with Generic medication name 
summarized for cardiovascular medication usage based on Implant 
population presented for Implant, pre-Discharge, MR Scan, MRI 
Visit+1-week, MRI Visit+1-month, MRI Visit+ 3-month, MRI  Visit+ 
6-month , MRI  Visit+ 9-month visits and Implant+1-year visits. 
     
5.3.4 Analysis of Adverse and Serious adverse events 
Subject-level event rates will be calculated at various time points (e.g. 
exact days) based on all events reported by the site regardless of whether 
they are ultimately adjudicated. Frequency of site reported Serious adverse 
events and non-serious adverse events and also Frequency of site-reported 
Serious adverse events and Non-serious adverse events are associated with 
the implant procedure up to MRI Visit+1 Month are exhibited using 
counts and percent with total available subjects based on safety 
population. The events are summarized by MedDRA system organ class 
and MedDRA system preferred terms with events and rates. 
 

Boston Scientific Corporation 
                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
  CONFIDENTIAL 
 
Page 17 of 19                                 
 
For calculating events and rates, need to consider ‘Events numbers’ are 
total episodes of each type of event among all subjects. ‘Rate of Subjects 
with Event’ numbers are percent of subjects who experienced one or more 
episodes of the event. ‘Events’ numbers for “TOTAL” are the sum of the 
individual event category totals. ‘Rate of Subjects with Event’ numbers 
for “TOTAL” is the percent of subjects who experienced an adverse event. 
 
5.3.5 Protocol Deviations 
A summary table for Deviations from Investigational Protocol collated 
during procedure and post procedure for all the planned events as 
specified in protocol. 
• Enrollment 
• Implant 
• Pre-Discharge 
• Partial Implant / Attempt + 1 Month 
• Medically Necessary Scan(MNS) 
• MRI Visit 
• MRI Visit + 1 Month 
• MRI Visit + 3 Month 
• MRI Visit + 6 Month 
• MRI Visit + 9 Month 
• 1 Year Follow-up Visit 
• Additional Visit 
• Adverse Events 
• Cardiovascular Medications 
• Device Deficiency 
• End of Study 
A summary table by protocol deviation are summarized with counts and 
percent and another summary table presented based on deviations reasons  
 
5.3.6 Device Deficiencies 
A table exhibited based on device deficiencies with out of service reasons 
been presented with count and percent for the available parameters with a 
supported listing. Also, a listing based on Device deficiency identifier with 
description and connected to SAE  with occurrence instance been listed 
for Implant population.  

Boston Scientific Corporation 
                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
  CONFIDENTIAL 
 
Page 18 of 19                                 
 
5.4  Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the 
analyses will be documented in an amended Statistical Analysis Plan approved 
prior to performing the analyses. Changes from the planned statistical methods 
after performing the analyses will be documented in the clinical study report 
along with a reason for the deviation.   
6. VALIDATION 
All clinical data reports generated per this plan will be validated per 90702587, Global 
WI: Clinical Data Reporting Validation. The validation level R1 chosen for all primary, 
secondary, safety and other additional endpoints. 
The validation program includes checking logs and generating compare reports in 
comparing with main programming datasets. 
7. PROGRAMMING CONSIDERATIONS 
All statistical programming tasks will be performed by IQVIA independently.  
7.1 Statistical Software 
All statistical analyses will be done using The SAS System Version 9.2 software or 
above (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 
27513, USA. All rights reserved.). 
7.2 Format of Output 
Results of analysis will be output programmatically to Microsoft Office® Word 
documents from SAS with no manual intervention. All output for the final statistical 
report will be in the form of a Word document containing tables, figures, graphs, and 
listings, as appropriate. 
7.3 Methods for Handling Missing Data 
No imputation method will be performed for the missing data handling. 
Missed or late visits will be recorded as Protocol Deviations. 
When calculating rates of treatment-emergent adverse events, missing and partial dates 
will be handled as shown in the table below. 
 
Partial Date 
Action Taken 
Entire adverse event onset date is 
missing 
The procedure date will be used for the 
onset date. 

Boston Scientific Corporation 
                              MR ICD CHINA,  SAP Version: AB 
 
                                                    Study Reference # C2082 
 
  CONFIDENTIAL 
 
Page 19 of 19                                 
 
Partial Date 
Action Taken 
The month and the day of the month are 
missing but the year is available  
January 1st will be used for the month and 
day of the onset date. However, if the 
imputed date falls before the procedure 
date, then the procedure date will be used 
for the onset date. 
Day is missing, but the month and year 
are available 
The 1st will be used as the day of the onset 
date. However, if the imputed date falls 
before the procedure date, then the 
procedure date will be used for the onset 
date. 
7.4 Rules and Definitions 
For baseline categorical variables, missing values will not be counted in rate 
denominators. Number of patients completing the visit will be considered in 
denominators. 
7.5 SAS code for Clopper-Pearson  
The confidence intervals for Clopper-Pearson and binomial proportion of CI are 
produced using PROC FREQ procedure. Below is a glimpse of sample code to extract 
the required values. For example, for the primary endpoint hypotheses for deriving 
Clopper-Pearson confidence limits, using the below dummy frequency table, coded as 
below: 
 
data main; 
 
input code $4. count; 
 
datelines; 
yes 56 
no  4 
; 
run; 
proc freq data=main order=freq; 
 
tables code / binomial (exact ) alpha=.05; 
 
tables code / binomial (cl=Wald ) alpha=.05; 
 
weight Count; 
run; 
The SAS code is presented for the binomial proportion for 95% Clopper-Pearson 
confidence intervals is specified. The use of ORDER=FREQ, in the SAS program, 
keep the highest frequency of success/failure as base and option binomial (EXACT) 
with alpha=0.05 will generate 95% Clopper-Pearson Confidence limits. We also get 
Wald’s (Asymptotic) 95 % Confidence limits that need to present in the exhibit.