Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
Conditions: Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Sponsor: Boston Scientific Corporation

CONFIDENTIAL 
____________________________________________________________________________________________________ 
Boston Scientific CRM 
 
S-ICD PAS Protocol 
 
 90976624 Ver. AB 
 
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S-ICD® System Post Approval Study  
(S-ICD PAS) 
 
 
CLINICAL PROTOCOL 
90976624 (CDM00055718) 
Version AB 
19 October, 2012 
NCT 01736618 
 
Study Reference Number C1850 
 
Sponsored By: 
Boston Scientific 
Cameron Health, Inc. DBA-Boston Scientific Cardiac Rhythm Management (CRM) 
4100 Hamline Ave. N. 
St. Paul, MN 55112 
Tel: 1.800.CARDIAC 
 
 
 
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. 
 
 
The S-ICD system is a registered trademark of Cameron Health, Inc. SQ-RX, Q-TECH, Q-TRAK, and Q-GUIDE are 
trademarks of Cameron Health, Inc.

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Table 1: Contact Information 
Role 
Contact  
Clinical Contact 
Michael Husby, MS 
Clinical Studies Manager 
Cameron Health 
DBA-Boston Scientific Cardiac Rhythm Management (CRM) 
4100 Hamline Ave. N.  
St. Paul, MN 55112 
 
Tel: 1.800.CARDIAC (227.3422) 
Cell: 312-402-1877 
michael.husby@bsci.com 
Boston Scientific 
CRM Technical 
Services 
Tel: 1.800.CARDIAC (227.3422) 
 

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1. PROTOCOL SYNOPSIS 
Study Name 
S-ICD Post Approval Study 
Objective: 
The primary purpose of the S-ICD Post Approval Study is to document long term safety and 
effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK 
electrode in a commercial clinical setting. 
Indications 
for Use 
The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening 
ventricular tachyarrhythmias in subjects who do not have symptomatic bradycardia, incessant ventricular 
tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with 
anti-tachycardia pacing.
Test Device 
The S-ICD System consists of four devices: 
 
SQ-RX subcutaneous implantable defibrillator pulse generator;  
 
Q-TRAK subcutaneous electrode; 
 
Q-GUIDE electrode insertion tool (EIT); 
 
Q-TECH programmer. 
Study Design 
The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects 
who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new 
candidates for the S-ICD System. 
Planned 
Number of 
Subjects 
The target enrollment sample size is 1,616 subjects to achieve 1,025 subjects in the analysis cohort at 60 
months.   
Planned 
Number of 
Centers 
Up to 150 centers in the US. 
Primary 
Endpoints 
 
The primary safety endpoint of the study is the Type I (caused by the S-ICD System) 
Complication Free Rate at 60 months compared to a performance goal of 85%. 
 
The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting 
Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal 
of 94%.
Secondary 
Endpoints 
 
The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 
60 months compared to a performance goal of 92.5%. 
 
The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced 
(Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a 
performance goal of 84.0%.

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Protocol Synopsis, Cont. 
Additional 
Pre-Specified 
Analyses 
 Freedom from complications requiring surgical revisions of the pulse generator or electrode, including 
pocket revisions, surgical repositioning or removal of the device in response to product performance 
issues 
 All cause mortality 
 Premature battery depletion and other device malfunctions 
 Mechanical electrode failures 
 Electrical performance data recorded by the device  (e.g., electrode impedance status, total number of 
treated and untreated episodes since implant and since the last follow-up session, total number of 
shocks delivered since implant and since the last follow-up session, stored ECGs for all treated and 
untreated episodes, changes to programmed parameters) 
 Explants and causes (e.g., infection, need for pacing therapy, inappropriate shocks) 
 TV-ICD implantation following S-ICD explant 
 Surgical revisions in response to suboptimal placement or system movement 
 Chronic pain/discomfort requiring surgical intervention 
 Clinical Indications for implant 
 Demographics and baseline characteristics of the implant population 
 Programmed SQ-RX pulse generator settings 
 System performance in key subgroups, including, but not limited to: gender, race, body habitus, 
NYHA class, indication 
 Individual rates of each adverse event category contributing to the primary and secondary safety 
endpoints 
 Whether subject was also a candidate for a TV-ICD and reason for S-ICD System implantation 
 Type of anesthesia/analgesia 
 Implant test analysis (induced episode VT/VF conversion , VT/VF detection sensitivity and time to 
therapy) 
 Management of antiplatelet and anticoagulation medications during implant 
 Removal of S-ICD system in response to implant testing 
 Use of medical imaging during implant 
 Syncope associated with VT/VF episodes 
 Use of dual zone programming and rate cutoffs 
 Spontaneous episodes of VT/VF 
 Incidence 
 Shock effectiveness (treated episodes only) 
 Time to therapy (treated episodes only) 
 Inappropriate shock incidence 
 SVT with high ventricular rate 
 Discrimination errors for AF/SVT in the conditional shock zone 
 Oversensing
Follow Up 
Schedule 
 
Screening 
 
Enrollment 
 
Implant 
 
Pre-Discharge 
 
Annual Follow-Up Visits through 60 months
Study 
Duration 
The duration is expected to be approximately 78 months from 1st enrollment to study closure. 
Inclusion 
Criteria 
 
Subjects must meet the following criteria to be eligible for inclusion in the study: 
1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System 
in the S-ICD System Clinical Investigation (IDE G090013) 
2. Willing and able to provide written informed consent or have informed consent provided by a legal 
representative
Exclusion 
Criteria 
Subjects who meet the following criteria must be excluded from the study: 
1. Remaining life expectancy of less than 360 days 

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Protocol Synopsis, Cont. 
Statistical Methods 
Primary 
Statistical 
Hypothesis 
 The lower confidence bound of the Type I (caused by the S-ICD System) Complication Free Rate at 
60 months is greater than 85%. 
 The lower confidence bound of the Overall Shock Effectiveness in Converting Spontaneous Discrete 
Episodes of VT/VF through 60 months is greater than 94%.
Statistical 
Test Methods 
 The primary safety endpoint will be evaluated as the proportion of subjects free from Type I 
Complication at 60 months based on the Kaplan-Meier method including the one-sided lower 95% 
confidence interval 
 The primary effectiveness endpoint of overall shock effectiveness for spontaneous discrete episodes of 
VT/VF will be examined using the binomial estimate including the one-sided 95% lower exact 
confidence bound.
Sample Size 
Parameters 
The analysis cohort is sized to provide at least 80% power for all primary and secondary endpoints 
analyses using a one-sided 5% significance level.  Additionally, the sample size is selected to ensure the 
two-sided upper 95% confidence bound of an assumed event rate of 0.4% is within 1% for each adverse 
event category contributing to the primary safety endpoint adverse events.  The attrition rate for the post-
approval study is expected to be similar to the S-ICD Clinical Investigation; therefore, the assumed 
annual attrition rate is 8.7%.  

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2. TABLE OF CONTENTS 
1. 
PROTOCOL SYNOPSIS .............................................................................................................................. 3 
2. 
TABLE OF CONTENTS .............................................................................................................................. 6 
3. 
INTRODUCTION .................................................................................................................................... 11 
4. 
DEVICE DESCRIPTION ............................................................................................................................ 12 
5. 
OBJECTIVES ........................................................................................................................................... 13 
6. 
ENDPOINTS ........................................................................................................................................... 13 
6.1 
Primary Safety Endpoint ......................................................................................................................... 13 
6.2 
Secondary Safety Endpoint ..................................................................................................................... 13 
6.3 
Individual Estimates for Secondary Safety Endpoint Related Events ...................................................... 14 
6.4 
Primary Effectiveness Endpoint .............................................................................................................. 14 
6.5 
Secondary Effectiveness Endpoint .......................................................................................................... 14 
6.6 
Additional Pre-Specified Safety Analyses ............................................................................................... 15 
7. 
DESIGN ................................................................................................................................................. 16 
7.1 
Scale and Duration ................................................................................................................................. 16 
7.2 
Visit Schedule .......................................................................................................................................... 17 
7.2.1 
Screening Log and Consent ........................................................................................................... 20 
7.2.2 
Enrollment ..................................................................................................................................... 20 
7.2.3 
Enrollment Data ............................................................................................................................ 21 
7.2.4 
Implant Procedure ......................................................................................................................... 21 
7.2.5 
Conversion Testing........................................................................................................................ 21 
7.2.6 
Implant Data .................................................................................................................................. 21 
7.2.7 
Pre-Discharge: Initial Device Set-Up and Programming .............................................................. 23 
7.2.8 
Pre-Discharge Data........................................................................................................................ 23 
7.2.9 
Annual Follow-up Visit ................................................................................................................. 24 
7.2.10 Additional Follow-up Visits .......................................................................................................... 25 
7.3 
Revisions, Replacements and Explants ................................................................................................... 27 
7.4 
Study Completion ................................................................................................................................... 28 
7.5 
Adverse events and Spontaneous Episode Classification ....................................................................... 29 
8. 
SUBJECT SELECTION .............................................................................................................................. 29 
8.1 
Subject Population .................................................................................................................................. 29 
8.2 
Devices Under Surveillance ..................................................................................................................... 29 
8.2.1 
SQ-RX Pulse Generator ................................................................................................................ 29 
8.2.2 
Q-TRAK Subcutaneous Electrode................................................................................................. 30 
8.2.3 
Q-GUIDE Electrode Insertion Tool .............................................................................................. 30 
8.2.4 
Q-TECH Programmer Description ................................................................................................ 31 
8.3 
Study Inclusion/Exclusion Criteria........................................................................................................... 32 
8.3.1 
Inclusion Criteria ........................................................................................................................... 32 
8.3.3 
Enrollment Completion ................................................................................................................. 32 

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8.4 
Investigator/Site Selection Criteria ......................................................................................................... 32 
8.5 
Justification for the Study Design ........................................................................................................... 34 
9. 
Subject Accountability .......................................................................................................................... 34 
9.1 
Point of Enrollment ................................................................................................................................. 34 
9.2 
Withdrawal ............................................................................................................................................. 34 
10. 
STATISTICAL CONSIDERATIONS ............................................................................................................. 35 
10.1 
Primary Safety Endpoint .................................................................................................................... 36 
10.1.1 Primary Safety Endpoint Performance Goal ................................................................................. 36 
10.1.2 Primary Safety Endpoint Hypothesis ............................................................................................ 36 
10.2 
Secondary Safety Endpoint ................................................................................................................ 37 
10.2.1 Secondary Safety Endpoint Related Adverse events ..................................................................... 37 
10.2.2 Secondary Safety Endpoint Performance Goal ............................................................................. 38 
10.2.3 Secondary Safety Endpoint Hypothesis ........................................................................................ 38 
10.2.4 Individual Estimates for Secondary Safety Endpoint Related Events ........................................... 38 
10.3 
Primary Effectiveness Endpoint ......................................................................................................... 39 
10.3.1 Primary Effectiveness Endpoint Performance Goal ...................................................................... 39 
10.3.2 Primary Effectiveness Endpoint Hypothesis ................................................................................. 39 
10.4 
Secondary Effectiveness Endpoint ..................................................................................................... 40 
10.4.1 Secondary Effectiveness Endpoint Performance Goal .................................................................. 40 
10.4.2 Secondary Effectiveness Endpoint Hypothesis ............................................................................. 40 
10.5 
Additional Pre-Specified Effectiveness Analyses ................................................................................ 41 
10.6 
Sample Size Determination ................................................................................................................ 41 
10.6.1 Target Sample Size ........................................................................................................................ 41 
10.7 
Data Analysis ..................................................................................................................................... 42 
10.7.1 Safety Endpoint Analyses ............................................................................................................. 42 
10.7.2 Individual Adverse events Analyses ............................................................................................. 42 
10.7.3 Additional Pre-Specified Safety Analyses .................................................................................... 42 
10.7.4 Effectiveness Endpoint Analyses .................................................................................................. 42 
10.7.5 Additional Pre-Specified Effectiveness Analyses ......................................................................... 43 
10.7.6 Baseline and Procedural Experience Analyses .............................................................................. 43 
10.7.7 Poolability Analysis ...................................................................................................................... 43 
10.7.8 Sensitivity Analysis ....................................................................................................................... 44 
10.7.9 Subgroup Analysis ........................................................................................................................ 44 
10.8 
Reports............................................................................................................................................... 45 
10.9 
Additional Pre-specified Analyses ...................................................................................................... 45 
10.10 
Other Statistical Considerations ........................................................................................................ 46 
11. 
ADVERSE EVENTS .................................................................................................................................. 46 
11.1 
Adverse event Reporting .................................................................................................................... 46 
11.2 
Adverse event Definitions .................................................................................................................. 47 
11.3 
Classification of Adverse events ......................................................................................................... 48 
11.4 
Device Deficiencies ............................................................................................................................ 49 
12. 
ELECTRONIC CASE REPORT FORM DATA COLLECTION ........................................................................... 49 
12.1 
Enrollment Form ................................................................................................................................ 50 

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12.2 
Implant Form ..................................................................................................................................... 50 
12.3 
Pre-Discharge Form ........................................................................................................................... 50 
12.4 
Annual Follow-up Visit Form .............................................................................................................. 50 
12.5 
Additional Follow-up Visit Form ........................................................................................................ 50 
12.6 
Revision, Replacement and Explant Forms ........................................................................................ 50 
12.7 
Study Completion Form ..................................................................................................................... 50 
12.8 
Protocol Deviations ............................................................................................................................ 51 
13. 
SUBJECT INFORMED CONSENT.............................................................................................................. 51 
14. 
INSTITUTIONAL REVIEW BOARD ........................................................................................................... 53 
15. 
CONFIDENTIALITY AND RISK ANALYSIS ................................................................................................. 53 
15.1 
Subject Confidentiality ....................................................................................................................... 53 
15.2 
Health Insurance Portability and Accountability Act (HIPAA) ............................................................ 54 
15.3 
Analysis of Risks ................................................................................................................................. 55 
15.4 
Risk Minimization .............................................................................................................................. 56 
15.5 
Potential Benefits .............................................................................................................................. 56 
16. 
COMPLIANCE ........................................................................................................................................ 56 
16.1 
Statement of Compliance .................................................................................................................. 56 
16.2 
Monitoring ......................................................................................................................................... 56 
16.3 
Complaint Reporting and Return of S-ICD Systems ........................................................................... 57 
16.4 
Securing Compliance.......................................................................................................................... 58 
16.5 
Insurance ........................................................................................................................................... 58 
17. 
RESPONSIBILITIES ................................................................................................................................. 58 
17.1 
Sponsor Responsibilities and Contact Information ............................................................................ 58 
17.2 
Role of Sponsor Field Clinical Engineers ............................................................................................. 58 
17.3 
Investigator Responsibilities .............................................................................................................. 59 
17.4 
Selection of Investigators ................................................................................................................... 60 
17.5 
Enrollment Commencement Requirements ....................................................................................... 60 
18. 
RECORDS AND REPORTING ................................................................................................................... 61 
18.1 
Investigator Records .......................................................................................................................... 61 
18.2 
Amendments to the Protocol ............................................................................................................. 62 
19. 
COMMITTEES ........................................................................................................................................ 62 
19.1 
Clinical Events Committee ................................................................................................................. 62 
20. 
SUSPENSION OR TERMINATION ............................................................................................................ 62 
20.1 
Premature Termination of the Study ................................................................................................. 62 
20.2 
Criteria for Premature Termination of the Study ............................................................................... 63 
20.3 
Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC Approval ............ 63 

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20.4 
Requirements for Documentation and Subject Follow-up ................................................................. 63 
20.5 
Criteria for Suspending/Terminating a Study Center ......................................................................... 64 
21. 
PUBLICATIONS POLICY .......................................................................................................................... 64 
Appendix A 
Acronyms and Definitions ....................................................................................................... 65 
Appendix B 
Definition of Time to Therapy ................................................................................................. 67 
Appendix C 
Source Document Annotation Guidelines ............................................................................... 68 
Appendix D 
Study Cohort Definitions ......................................................................................................... 69 
Appendix E 
Screening ECG ......................................................................................................................... 70 
 

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TABLES 
Table 1: Contact Information .................................................................................................... 2 
Table 2: Summary of Information Required Each Visit ......................................................... 19 
Table 3: Screening Log Data .................................................................................................. 20 
Table 4: Enrollment Data Collection ...................................................................................... 21 
Table 5: Implant Data Collection ............................................................................................ 22 
Table 6: Pre-Discharge Data Collection ................................................................................. 23 
Table 7: Annual Follow-Up Visit Data Collection ................................................................. 25 
Table 8. Additional Follow-Up Visit Data Collection ............................................................ 26 
Table 9. System Revision Data Collection.............................................................................. 27 
Table 10. Study Completion Data Collection ......................................................................... 28 
Table 11: Variable matrix summarizing subgroup analyses ................................................... 45 
Table 12: Investigator Reporting Timelines for Deaths and Clinical Events ......................... 46 
 

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3. INTRODUCTION 
Results from large, prospective, randomized clinical trials have previously demonstrated 
the mortality benefit of transvenous ICD (TV-ICD) usage in primary1,2 and secondary3 
prevention subjects.  In spite of the overall success of TV-ICD therapy, the complications 
associated with the therapy have come under increased scrutiny in light of several highly 
publicized device recalls in recent years. 
A large proportion of the complications associated with TV-ICD therapy are related to 
leads that are implanted intravascularly. The implantation of such leads runs the risk of 
specific clinical complications such as pericardial tamponade, perforation and 
pneumothorax. In addition, repositioning of leads in the event of dislodgement, fracture 
or other mechanical failure has an associated risk.  In a report on approximately 31,000 
Medicare beneficiaries who underwent ICD implantation between October 2002 and 
September 2003, 11% experienced one or more early complications.4  In smaller studies, 
overall complication rates have been reported to be as high as 30% after approximately 4 
years of follow-up with lead-related complication rates accounting for 15% of events.5 
More recently, data published by Borleffs et al6 and Kleeman et al7 indicate that lead 
failure rates can be as high as 20-40% over 8-10 years of follow-up. 
The S-ICD System was designed to minimize or eliminate many of the complications 
associated with traditional TV-ICD leads.  The S-ICD System does not require an 
electrode to be placed either in (endocardially) or on (epicardially) the heart, which may 
be advantageous in reducing: 
 Implant-associated risks related to central venous access or endocardial lead 
positioning and fixation. 
 Exposure of the lead to stresses induced by repeated cardiac pulsations 
 
1 Moss AJ et al., Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in 
subjects with myocardial infarction and reduced ejection fraction. (2002). N. Engl. J. Med. 346:  877-883 
2 Bardy GH et al., Amiodarone or an Implantable Cardioverter-Defibrillator for Congestive Heart Failure (2005). N. Engl. J. Med. 352: 225-
237 
3 The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with 
implantable defibrillators in subjects resuscitated from near-fatal ventricular arrhythmias. (1997) N. Engl. J. Med. 337: 1576-1583 
4 Reynolds MR et al.The Frequency and Incremental Cost of Major Complications Among Medicare Beneficiaries Receiving Implantable 
Cardioverter Defibrillators (2006). J. Am. Coll. Cardiol. 47:  2493-2497 
5 Alter P., et al., Complications of Implantable Cardioverter Defibrillator Therapy in 440 Consecutive Subjects (2005). Pacing Clin 
Electrophysiol. 28: 926-932 
6 Borleffs CJW et al., Risk of Failure of Transvenous Implantable Cardioverter Defibrillator Leads (2009) Circ Arrhythmia Electrophysiol. 
2:411-416 
7 Kleeman T et al., Annual Rate of Transvenous Lead defects in implantable cardioverter-defibrilators over a period of > 10 yrs. (2007) 
Circulation 115: 2474-2480 

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 Infections with a direct pathway to the blood stream and endocardium 
 Complications related to lead extraction 
 Exposure to radiation and contrast dye during implant 
The safety and effectiveness of the S-ICD System was demonstrated in a series of trials 
that culminated in the S-ICD Clinical Investigation conducted under IDE G090013.  The 
initial human studies of the S-ICD System include two acute and two long-term studies 
conducted in New Zealand and Europe.8  These studies provided the rationale for the S-
ICD System Clinical Investigation, which was a 330 subject, single-arm, prospective, 
non-randomized, multicenter clinical study in the United States, New Zealand, the 
Netherlands and the United Kingdom.  The co-primary endpoints for safety and efficacy 
were met in the S-ICD System Clinical Investigation: 
 The 180-day system related complication-free rate of 99% [LBCI95=97.3%] 
passed the pre-specified primary safety endpoint criteria of 79% 
 The acute VF conversion rate of 96.5% [LBCI95=93.8%] passed the pre-specified 
primary effectiveness endpoint criteria of 88%.   
4. DEVICE DESCRIPTION 
The S-ICD System is an implantable defibrillator that treats ventricular tachyarrhythmias 
using a subcutaneous pulse generator and a subcutaneous electrode rather than a 
transvenous lead.  The S-ICD System received CE mark in 2009, PMA Approval in 2012 
(anticipated) and is approved for distribution in the countries in which the study will be 
conducted.  Current and future models of each device will be included in the study. 
The S-ICD System consists of four devices: 
 SQ-RX subcutaneous implantable defibrillator pulse generator; Model 1010 and 
future models. 
 Q-TRAK subcutaneous electrode; Model 3010 and future models 
 Q-GUIDE electrode insertion tool (EIT); Model 4010 and future models 
 Q-TECH programmer; model 2020 and future models. 
 
8 Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363(1):36-44. 

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The S-ICD System is designed to work with the following accessories: 
 Programmer telemetry wand; 
 Magnet; 
 Suture sleeve, included in the electrode package; 
 Torque wrench, included in the pulse generator package; 
 SD memory card. 
 The S-ICD system also requires the use of a surface ECG based “screening tool” which 
is used to determine the adequacy of sensing. 
5. OBJECTIVES 
The primary objective of the S-ICD Post Approval Study is to document long-term safety 
and effectiveness outcomes associated with the implantation of the SQ-RX pulse 
generator and Q-TRAK electrode in commercial clinical subjects.  Additional objectives 
include characterization of long term safety and effectiveness in subjects of varied body 
habitus and in traditionally underrepresented subject populations, such as women and 
African Americans.  
6. ENDPOINTS 
6.1 Primary Safety Endpoint 
The primary safety endpoint of the study is defined as the Type I Complication Free Rate 
at 60 months (1800 days).  Type I complications are adverse events caused by a 
component (i.e. pulse generator, electrode, EIT or programmer) of the S-ICD System that 
results in permanent loss of device function,9 invasive intervention or death. 
6.2 Secondary Safety Endpoint 
The secondary safety endpoint of the study is defined as the Electrode-Related 
Complication Free Rate at 60 months. A complication is an adverse event that results in 
permanent loss of device function,10 invasive intervention or death. Electrode relatedness 
is defined in section 10.2.1.  
 
9 Permanent loss of device function refers to: 1) the permanent loss of shock therapy and/or post shock pacing; 
 2) permanent loss of appropriate sensing in all available sensing configurations (oversensing that results in 
persistent inappropriate shocks or undersensing that could lead to undetected arrhythmias).  Loss of device 
function includes programming the PG permanently off or temporarily off in advance of an explant/revision. 
 
10 Permanent loss of device function refers to: 1) the permanent loss of shock therapy and/or post shock pacing; 
 2) permanent loss of appropriate sensing in all available sensing configurations (oversensing that results in 

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6.3 Individual Estimates for Secondary Safety Endpoint Related Events  
In addition to the composite rate of electrode related complications, individual rates of 
each adverse event category contributing to the primary safety endpoint will be examined 
including two-sided 95% exact confidence intervals. 
6.4 Primary Effectiveness Endpoint 
The primary effectiveness endpoint of the study is defined as the Overall Shock 
Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 
months.  Overall shock effectiveness refers to conversion of an episode following any of 
the 5 shocks (maximum) that may be delivered during a single episode.  Discrete episodes 
of VT/VF are those that are temporally independent (<3 within a 24 hour period), unlike 
storm episodes, which occur in clusters (≥3 episodes within a 24 hour period).  Episodes 
that spontaneously terminate will be excluded from this endpoint since the effectiveness 
of the shock cannot be evaluated in such circumstances. 
6.5 Secondary Effectiveness Endpoint 
The secondary effectiveness endpoint of the study is defined as First Shock Effectiveness 
in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 
months.  Induced episodes following the initial implant procedure after enrollment (i.e., 
acute) will be counted towards the endpoint using the first shock delivered in the final 
position and final polarity.  Because VT/VF induction test shocks are expected to be 
delivered at an energy below 80 J (e.g., 65 J), poolability with spontaneous episode 
shocks (all delivered at 80 J, non-programmable) will be assessed for the primary 
analysis.  If the two data sets differ, separate analyses will be presented for first shock 
efficacy of induced episodes and first shock efficacy of spontaneous episodes. 
 
persistent inappropriate shocks or undersensing that could lead to undetected arrhythmias).  Loss of device 
function includes programming the PG permanently off or temporarily off in advance of an explant/revision. 

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6.6 Additional Pre-Specified Safety Analyses 
Additional pre-specified safety analyses include: 
 Freedom from complications requiring surgical revisions of the pulse generator or 
electrode, including pocket revisions, surgical repositioning or removal of the 
device in response to product performance issues (the 95.0% one-sided lower 
confidence interval should exceed 75.0%.) 
 Individual rates of each adverse event category contributing to the primary and 
secondary safety endpoints will be examined including two-sided 95% exact 
confidence intervals  
 All cause mortality 
 Premature battery depletions and other device malfunctions 
 Electrical performance data recorded by the device (e.g., electrode impedance 
status, total number of treated and untreated episodes since implant and since the 
last follow-up session, total number of shocks delivered since implant and since 
the last follow-up session, stored ECGs for all treated and untreated episodes, 
changes to programmed parameters) 
 Mechanical electrode failures 
 Explants and causes (e.g., infection, need for pacing therapy, inappropriate 
shocks) 
 TV-ICD implantation following S-ICD explant 
 Surgical revisions in response to suboptimal placement or system movement 
 Chronic pain/discomfort requiring surgical intervention 
 Removal of S-ICD System in response to implant testing 
 Syncope associated with VT/VF episodes 
 Inappropriate shock incidence 
 SVT with high ventricular rate 
 Discrimination errors for AF/SVT in the conditional shock zone 
 Oversensing 

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7. DESIGN 
The S-ICD Post Approval Study is a multi-site, non-randomized registry that will 
retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE 
G090013) and prospectively enroll subjects eligible for de novo implantation with the S-
ICD System. Subjects will be followed annually according to standard of care through 60 
months post implant or study exit.  This study will follow 21 CFR 814.82(a)(2) Post-
Approval Requirements. 
7.1 Scale and Duration 
The study will be conducted by approximately 100 (up to 150) US sites.  At least 1,616 
subjects will be enrolled. Sites may continue to enroll subjects until notified of enrollment 
completion.  Sites may not enroll more than 15% of the enrollment target (242 subjects) 
without written permission from the sponsor.  The duration of the study, from first 
enrollment to study closure, is expected to be approximately 78 months. 
 Study initiation will begin approximately 3 months post PMA approval 
 The number of sites with IRB approvals per month is estimated to be 
approximately 10 per month. 
 Estimated first enrollment is 4 months post PMA approval. 
 The number of enrollments per month is estimated at 80-100, once all sites are 
approved to enroll. 
 The estimated date to complete enrollment is 18 months after the first enrollment. 
 The estimated date to complete follow-up is 60 months after enrollment is 
complete. 
 The final study report will be submitted no later than 3 months after the last 
participant completes follow-up. 

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7.2 Visit Schedule 
Subjects will be followed according to the standard of care at the implanting/following 
institution.  Data will be collected from each subject at enrollment, implant, pre-
discharge, annual follow-up visits and from additional follow up visits associated with a 
Type I-II clinical event, device episode, suspected device malfunction or device 
programming change.  Data will be collected through at least 60 months (1800 days) post 
implant or through study exit.

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Figure 1. Subject Flow 
 

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Table 2: Summary of Information Required Each Visit 
 
Failed ECG 
Screen 
Passed Screening ECG 
Screening 
log 
Screening 
log 
Enrollment 
Visit 
Implant 
Pre-
Discharge 
Annual 
Follow-up 
Visit 
Additional 
Follow-up 
Visit 
System 
Revision 
Additional 
implant 
Study 
Completion 
“Screening ECG” Consent 
Date 
X 
X 
 
 
 
 
 
 
 
 
Screening ECG 
X 
X 
 
 
 
 
 
 
 
 
“S-ICD PAS” Consent Date 
 
X 
 
 
 
 
 
 
 
 
Baseline Characteristics 
 
 
X 
 
 
 
 
 
 
 
Cardiovascular Medications 
 
 
X 
 
 
 
 
 
 
 
Implant Details 
 
 
 
X 
 
 
 
 
X 
 
S-ICD System Parameters 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Conversion Testing (w/ 
external ECG strips11) 
 
 
 
Y 
Y 
Y 
 Y 
Y 
Y 
Y 
Adverse events 
 
 
 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Spontaneous Episodes 
 
 
 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Chest X-Ray 
 
 
 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
X: Data Collected. 
Y: Must assess whether the event occurred; additional data entered only if the event occurred. 
 
11 External ECGs are only required for sustained inductions that are shocked by the S-ICD System or external defibrillator. 

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7.2.1 Screening Log and Consent 
All subjects who undergo a screening ECG to determine eligibility for implantation with 
the S-ICD System will sign a ‘Screening ECG” Informed Consent Form (ICF) and be 
entered into the screening log.  All screening ECGs (in all leads and postures evaluated) 
are to be uploaded as attachments to the screening log.  Both passed and failed Screening 
ECGs are to be collected in the screening log. The Screening ECG ICF applies only to the 
screening ECG and does not enroll the subject in the study.  For subjects who fail the 
screening ECG, no further data are to be collected.  For subjects who pass the screening 
ECG, study participation must be systematically offered to all subjects in order to avoid 
bias in subject selection.  Subjects who choose to participate must sign the “S-ICD PAS” 
ICF.  A subject who signs the “S-ICD PAS” ICF and does not proceed to the implant 
procedure will not count toward the enrollment ceiling. 
Table 3: Screening Log Data 
Data Collection 
Retention of Original Source 
Documentation 
“Screening ECG” for all subjects screened12 
 
“S-ICD PAS Consent” Form if subject to undergo an implant 
procedure 
Investigational Center 
 
Pre-operative screening ECG 
Investigational Center; upload copy to 
BSC 
 
7.2.2 Enrollment 
Participants in the S-ICD Clinical Investigation (G090013), including subjects enrolled 
under an approved compassionate use application, are considered enrolled after providing 
written informed consent.  All other subjects are considered enrolled after providing 
written informed consent and undergoing an implant procedure for the S-ICD System.  
For the purpose of this protocol, any subject receiving anesthesia for an S-ICD System 
implant will be considered to have undergone an implant procedure.  Subjects who do not 
receive anesthesia in preparation for an S-ICD System implant procedure will not be 
considered to be enrolled in the study.   
 
12 The Screening ECG consent form may be used to collect screening ECGs from any subject who is screened.  
This includes subjects who pass the ECG screening criteria, but do not sign the S-ICD PAS consent. 

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7.2.3 Enrollment Data 
Subject demographics, medical history and indications will be collected for all enrolled 
subjects.  Table 4 lists the data collected at the enrollment visit. 
Table 4: Enrollment Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
Demographics Physical and Medical History 
 
Cardiovascular Medications 
Investigational Center 
 
7.2.4 Implant Procedure 
Implant, testing, and programming the S-ICD System should be performed using the 
standard of care methods established by the investigational center. Refer to the S-ICD 
System User’s Manual for detailed instructions regarding the implantation and use of the 
S-ICD System.   
7.2.5 Conversion Testing 
As part of the S-ICD System implant procedure, conversion testing should be performed 
according to the standard practices of the investigator.  Conversion testing may also be 
performed at other times during the course of the study at the discretion of the 
investigator.  Only sustained ventricular arrhythmias that result in a shock, either from the 
S-ICD System or from an external defibrillator, require documentation by capturing and 
annotating an ECG strip. 
7.2.6 Implant Data 
S-ICD System procedural data such as peri-operative medication management, use of 
medical imaging, product information, VT/VF conversion testing, programming 
parameters and adverse events are collected at implant.  The initial implant and any 
additional implant procedures have the same data requirements, as described in this 
section. Table 5 lists the data collected at the implant visit. 

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Table 5: Implant Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
Peri-operative medication worksheet (anticoagulation; 
antiplatelets; antibiotics; type of anesthesia) 
 
Implanted product and accessories utilized for S-ICD System 
(model/serial/lot/batch/etc.) 
 
Medical notes/worksheets documenting use of medical imaging 
(e.g., fluoroscopy) 
 
Adverse events, if applicable 
Investigational Center 
 
 
Q-TECH Programmer Printouts: 
- Final Summary Report 
- Captured S-ECG in each sensing vector 
- Device episodes, if applicable 
 
Shocked induced VT/VF episodes (external ECG strips),13 if 
performed 
 
Post implant chest x-ray(s) if applicable14 
 
Investigational Center; upload copy 
to Cameron Health/BSC  
 
SD Card Data 
Cameron Health/BSC (e.g. via 
CAMELION)
 
 
13 Any time induction testing is performed in the study, external ECG strips are only required for sustained 
ventricular arrhythmias that result in a shock, either from the S-ICD System or from an external defibrillator. 
14 An X-ray is not required per protocol; upload only if a chest x-ray of the S-ICD System  was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse event, or suspected product issue. 

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7.2.7 Pre-Discharge: Initial Device Set-Up and Programming 
All device programming is at the discretion of the investigator.  Investigators are 
encouraged to use two zones when appropriate, based on results from the S-ICD Clinical 
Investigation showing that dual zone programming significantly reduces adverse events 
for inappropriate shocks. In that study, dual zone programming was associated with a 
70% relative reduction in the incidence of inappropriate shocks due to SVT and a 56% 
relative reduction in the incidence of inappropriate shocks due to oversensing, when 
compared to single zone programming. 
 
7.2.8 Pre-Discharge Data 
Captured ECGs in each sensing vector may be obtained any time prior to pre-discharge.  
Additionally, programming parameters and any VT/VF conversion testing, adverse events 
or x-rays are collected at pre-discharge.  Table 6 summarizes the data required at the pre-
discharge visit.  
Table 6: Pre-Discharge Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
 
Adverse events, if applicable 
Investigational Center 
 
 
Q-TECH Programmer Printouts: 
- Initial and Final Summary Reports 
- Captured S-ECG in each sensing vector, if sensing vector 
changed 
- Device episodes, if applicable 
 
Shocked induced VT/VF episodes (external ECG strips),15 if 
performed 
 
Chest x-ray(s) if applicable16 
 
Investigational Center; upload copy 
to Cameron Health/BSC  
 
SD Card Data 
Cameron Health/BSC (e.g. via 
CAMELION)
 
 
 
15 Any time induction testing is performed in the study, external ECG strips are only required for sustained 
ventricular arrhythmias that result in a shock, either from the S-ICD System or from an external defibrillator. 
16 An X-ray is not required per protocol; upload only if a chest x-ray of the S-ICD System  was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse event, or suspected product issue. 

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7.2.9 Annual Follow-up Visit 
After implant, scheduled follow-up visits are to be performed annually (±60 days) from 
the implant date in order to capture: 
 Spontaneous episodes that have not been previously reported; 
 Adverse events that have not been previously reported; 
 Programming changes that have not been previously reported; 
 Product experience reports that have not been previously reported. 
 
For participants in the S-ICD Clinical Investigation (IDE G090013), annual follow-up 
visit windows are calculated from the original S-ICD System implant date (day 0) and 
take into account the last follow-up visit conducted in the S-ICD Clinical Investigation 
(e.g., if the last follow-up conducted in the S-ICD Clinical Investigation (IDE G090013) 
was the 540 day follow-up visit, then the first S-ICD PAS annual follow-up visit should 
occur at 720 days post implant). 
Aside from the annual follow-up visit, other scheduled and unscheduled visits throughout 
the year (e.g., standard of care device checks) should not be submitted unless they are 
associated with a Type I-II clinical event, device episode, suspected device malfunction 
or device programming change17, in which case they should be submitted as additional 
follow-up visits as described in Section 7.2.10, below. 
The final annual follow-up visit must occur more than 1800 days after the initial implant 
procedure.  The first standard of care visit within the annual follow-up visit window that 
occurs after the 1800 day mark should be submitted as an annual follow-up visit; if that is 
not possible, then the next standard of care visit may be submitted as an additional 
follow-up visit to allow for timely study completion.  Table 7 lists all the data required at 
annual follow-up visits. 
 
17 A programming change refers to any difference between Initial Device Settings and Current Device Settings 
under the Programmable Parameters section of an S-ICD Summary Report. 

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Table 7: Annual Follow-Up Visit Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
 
Adverse events, if applicable 
Investigational Center 
 
 
Q-TECH Programmer Printouts: 
- Initial and Final Summary Reports 
- Captured S-ECG in each sensing vector 
- Device episodes, if applicable 
 
Shocked induced VT/VF episodes (external ECG strips),18 if 
performed 
 
Chest x-ray(s) if applicable19 
 
Investigational Center; upload copy 
to Cameron Health/BSC  
 
SD Card Data 
Cameron Health/BSC (e.g. via 
CAMELION)
 
7.2.10 Additional Follow-up Visits 
Physician office visits, emergency room visits, out-patient hospital visits, and 
hospitalizations related to the S-ICD System (associated with a Type I-II adverse event, 
treated episode, suspected device malfunction or device programming changes20) should 
be recorded as an additional follow-up visit.  A subject status check may also be 
performed by telephone and recorded as an additional follow-up visit under special 
circumstances defined by the sponsor or in order for the subject to complete the study 
after 1800 days post implant; otherwise, additional follow-up visits should not be reported 
unless they are associated with a Type I-II adverse event, treated episode, suspected 
device malfunction or device programming changes.    Table 8  lists all the data required 
from additional follow-up visits. 
 
18 Induction testing is not required per protocol; upload only if performed.  Any time induction testing is performed 
in the study, external ECG strips are only required for sustained ventricular arrhythmias that result in a shock, 
either from the S-ICD System or from an external defibrillator. 
19 An X-ray is not required per protocol; upload only if a chest x-ray of the S-ICD System  was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse event, or suspected product issue. 
20 A programming change refers to any difference between Initial Device Settings and Current Device Settings 
under the Programmable Parameters section of an S-ICD Summary Report. 

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Table 8. Additional Follow-Up Visit Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
 
Adverse events, if applicable 
Investigational Center 
 
 
Q-TECH Programmer Printouts: 
- Initial and Final Summary Reports 
- Captured S-ECG in each sensing vector, if sensing vector 
changed 
- Device episodes, if applicable 
 
Shocked induced VT/VF episodes (external ECG strips),21 if 
performed 
 
Chest x-ray(s) if applicable22 
 
Investigational Center; upload copy 
to Cameron Health/BSC  
 
SD Card Data (if new spontaneous episodes were recorded) 
Cameron Health/BSC (e.g. via 
CAMELION)
 
 
21 Induction testing is not required per protocol; upload only if performed.  Any time induction testing is performed 
in the study, external ECG strips are only required for sustained ventricular arrhythmias that result in a shock, 
either from the S-ICD System or from an external defibrillator. 
22 An X-ray is not required per protocol; upload only if a chest x-ray of the S-ICD System  was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse event, or suspected product issue. 

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7.3 Revisions, Replacements and Explants 
In the event that the electrode or PG is surgically revised after the initial implant 
procedure, the system revision form is used to record changes to the system. If either the 
PG or electrode is removed from service, a device status form must be completed for the 
out-of-service device(s).  If the system is revised without replacing any system 
components, a system revision form is completed. If the PG or electrode is replaced, the 
new device(s) will be recorded on an additional implant form.  Table 9 lists all the data 
required for system revisions. 
 
Table 9. System Revision Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
 
Adverse events, if applicable 
 
Newly implanted product and accessories utilized for S-ICD 
System (model/serial/lot/batch/etc.), if applicable 
Investigational Center 
 
Q-TECH Programmer Printouts: 
- Initial and Final Summary Reports 
- Captured S-ECG in each sensing vector, if sensing vector 
changed 
- Device episodes, if applicable  
 
Shocked induced VT/VF episodes (external ECG strips),23 if 
performed 
 
Chest x-ray(s) if applicable24 
 
Investigational Center; upload copy 
to Cameron Health/BSC  
 
SD Card Data (if new spontaneous episodes were recorded) 
Cameron Health/BSC (e.g. via 
CAMELION)
 
 
23 Induction testing is not required per protocol; upload only if performed.  Any time induction testing is performed 
in the study, external ECG strips are only required for sustained ventricular arrhythmias that result in a shock, 
either from the S-ICD System or from an external defibrillator. 
24 An X-ray is not required per protocol; upload only if a chest x-ray of the S-ICD System was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse event, or suspected product issue. 

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7.4 Study Completion 
Subjects may be withdrawn from the study for a variety of reasons including: 
 Subject withdraws consent for any reason; 
 Subject is lost to follow-up despite best efforts to locate the subject; 
 The S-ICD System is permanently explanted; 
 The subject has been followed >60 months from the original implant date. 
Subjects who undergo a permanent explant or who commence, but do not complete, an 
implant procedure should be contacted, either in person or by telephone, at least 30 days 
after the permanent explant or implant attempt in order to record any adverse events 
before being withdrawn from the study.  The study completion form documents 
withdrawal of any subject from the study. 
There are no additional follow-up requirements once a subject has been withdrawn from 
the study.  Table 10 lists all the data that are required for study completion. 
Table 10. Study Completion Data Collection 
Data Collection 
Retention of Original Source 
Documentation 
 
Adverse events, if applicable 
Investigational Center 
 
 
Q-TECH Programmer Printouts: 
- Initial and Final Summary Reports 
- Captured S-ECG in each sensing vector, if sensing vector 
changed 
- Device episodes, if applicable  
 
Shocked induced VT/VF episodes (external ECG strips),25 if 
performed 
 
Death letter, if applicable 
 
Chest x-ray(s) if applicable26 
 
Investigational Center; upload copy 
to Cameron Health/BSC  
 
SD Card Data (if new spontaneous episodes were recorded) 
Cameron Health/BSC (e.g. via 
CAMELION)
 
25 Induction testing is not required per protocol; upload only if performed.  Any time induction testing is performed 
in the study, external ECG strips are only required for sustained ventricular arrhythmias that result in a shock, 
either from the S-ICD System or from an external defibrillator. 
26 An X-ray is not required per protocol; upload only if a chest x-ray of the S-ICD System was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse event, or suspected product issue. 

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7.5 Adverse events and Spontaneous Episode Classification 
Complications and treated spontaneous episodes will be preliminarily classified by 
investigational sites and reviewed for final adjudication by a Clinical Events Committee 
(CEC). 
8. SUBJECT SELECTION 
Subjects with a remaining life expectancy of at least 360 days who are eligible for 
implantation with an S-ICD System, OR who were previously implanted with an S-ICD 
System in the S-ICD System Clinical Investigation (IDE G090013) study, are eligible for 
participation.  Approximately 1,616 subjects will be enrolled at a maximum of 150 
investigational sites. 
8.1 Subject Population 
Any subject who meets the inclusion criteria, does not meet the exclusion criterion, and 
provides informed consent will be enrolled in the study upon undergoing an implant 
procedure for the S-ICD System.  Subjects who do not undergo an implant procedure will 
not count toward the enrollment ceiling. 
8.2 Devices Under Surveillance 
The following information is a brief summary of the S-ICD System and its principle of 
operation.  Refer to the S-ICD System User’s Manuals for additional information. 
8.2.1 SQ-RX Pulse Generator 
The SQ-RX pulse generator comprises an inner structure of discrete electrical 
components, interconnected low power and high power hybrid assemblies, batteries, and 
high energy capacitors.  The inner assembly is enclosed in a hermetically sealed can with 
a pre-moulded polyurethane header for electrode connection.  The header contains a 
single port for connection of the Q-TRAK subcutaneous electrode to accommodate 
sensing, pacing, and defibrillation.  The SQ-RX pulse generator weighs approximately 
145 grams with a volume of about 69 cc.  The SQ-RX pulse generator is designed to 
provide defibrillation therapy using a constant tilt biphasic waveform.  The SQ-RX pulse 
generator is capable of delivering high energy defibrillation shocks as well as bradycardia 
demand mode cardiac pacing for a period up to thirty seconds following defibrillation 
therapy.  Future generations of the SQ-RX pulse generator may be included in the study. 

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8.2.2 Q-TRAK Subcutaneous Electrode 
The Q-TRAK subcutaneous electrode comprises one high voltage defibrillation coil for 
the purpose of providing defibrillation energy.  It is constructed using multifilars of 
metallic wire formed into a coil.  The Q-TRAK subcutaneous electrode is also equipped 
with a proximal and distal sense electrode, which enables the S-ICD System to evaluate 
multiple sensing vectors in order to identify the best sensing vector to use for each 
subject.  The sense electrodes are constructed using metallic tubing mechanically affixed 
to the body of the electrode.  These sense electrodes are electrically insulated from the 
shock electrode by a multi-lumen polymeric tube. 
Electrical connectivity to the SQ-RX pulse generator is provided using multiple strands of 
insulated metallic cable inserted into the same multi-lumen polymeric tube.  This tube 
comprises the body of the Q-TRAK subcutaneous electrode and is subcutaneously 
implanted from the device pocket along the rib margin to the sternum.  The proximal 
termination of the Q-TRAK subcutaneous electrode comprises a multi-pole connector to 
plug into the header of the SQ-RX pulse generator.  This connector is designed to be 
compatible with the SQ-RX pulse generator only. Future generations of the Q-TRAK 
subcutaneous electrode may be included in the study. 
8.2.3 Q-GUIDE Electrode Insertion Tool 
The Q-GUIDE EIT is a single use, disposable subcutaneous tunneling tool which is used 
to facilitate predictable placement of the Q-TRAK subcutaneous electrode.  There is one 
model of the Q-GUIDE EIT, which has a shaft length of 26.7 cm. The Q-GUIDE EIT is 
designed to create an appropriately sized subcutaneous sinus for the Q-TRAK 
subcutaneous electrode such that the electrode will fit securely and not loosely in the 
subcutaneous sinus.  The tip of the Q-GUIDE EIT and the tip of the Q-TRAK 
subcutaneous electrode are equipped with suture holes which enable the two devices to be 
temporarily sutured together during the implant procedure.  Once the two devices are 
sutured together, the Q-GUIDE EIT can be used to pull the Q-TRAK subcutaneous 
electrode through a subcutaneous sinus.  Future generations of the Q-GUIDE EIT may be 
included in the study. 

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8.2.4 Q-TECH Programmer Description 
The Q-TECH programmer is a completely self-contained, non-sterile, non-implantable, 
lightweight, easily portable computer that does not allow general purpose computing.  It 
implements a graphical user interface (GUI) design which gathers user input via touch 
screen and/or keyboard.  It has a 600 x 800 pixel resolution display (high quality SVGA 
size) and is 9.25 x 7.24 x 1.38 inches when closed, weighing 2.55 pounds.  The unit 
operates off of a rechargeable lithium ion battery pack or AC power via its wall power 
source.   
Communication between the SQ-RX pulse generator and the Q-TECH programmer is 
accomplished through an RF telemetry wand.  The RF telemetry wand includes a 
connector designed to be inserted into or removed from a custom PCMCIA radio card. 
The radio card itself is designed to be irremovable from the Q-TECH programmer.  The 
radio link operates in the Medical Implant Communication Service band specified in EN 
301 839-1:2002 and complies with applicable FCC regulations.  The Q-TECH 
programmer is capable of recognizing multiple SQ-RX pulse generators, but active 
communication is permitted with only one SQ-RX pulse generator at a time.  
Communication between the Q-TECH programmer and a printer is based on a standard 
Bluetooth piconet. 
The Q-TECH programmer application consists of multiple screens from which online 
(active communication with the SQ-RX pulse generator) and offline modes may be 
commanded.  Q-TECH programmer functionality includes: 
 Scan for devices, resulting in a display of pick list of SQ-RX devices 
 Establishment and termination of communication link 
 Display of a real-time S-ECG  
 Selection of programmable parameters  
 Review of subject event history 
 
  Future generations of the Q-TECH programmer may be included in the study. 

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8.3 Study Inclusion/Exclusion Criteria 
8.3.1 Inclusion Criteria 
Subjects must meet the following criteria to be eligible for inclusion in the study: 
 Eligible for implantation with an S-ICD System, OR previously implanted with an 
S-ICD System in the S-ICD System Clinical Investigation (IDE G090013) 
 Willing and able to provide written informed consent or have informed consent as 
provided by a legal representative 
8.3.2 Exclusion Criterion 
Subjects who meet the following criterion must be excluded from the study: 
 Remaining life expectancy of less than 360 days 
8.3.3 Enrollment Completion 
Investigational sites will be notified to cease enrolling subjects for this study when the 
enrollment target is reached or at the sponsor’s discretion in consultation with FDA. This 
notification is expected to happen when at least 1,616 subjects have been enrolled. 
8.4 Investigator/Site Selection Criteria 
The sponsor will consider many factors to ensure selection of sites and investigators that 
are qualified through their training and experience to properly conduct the study. Diverse 
sites will be selected with respect to geography and clinical setting (e.g., university, 
private practice, etc.). The current BSC process for evaluating and selecting clinical sites 
will be utilized.  The evaluation and selection criteria include but are not limited to the 
following: 
 Participation in the S-ICD Clinical Investigation (G090013) 
 Sites that have the personnel with knowledge to run a clinical study and enroll 
subjects according to FDA and good clinical practice guidelines. It is 
recommended that sites have a dedicated Research Coordinator and exceptions 
will be evaluated on a case-by-case basis  
 Sites that have a Principal Investigator (physician) who has a commitment to 
conducting research and is in good standing with the FDA 

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  Sites that have the necessary knowledge and experience to implant CRM products 
and also have the potential subject volume to meet enrollment expectations  
 Site personnel that have a commitment to protocol compliance along with 
gathering and submitting timely and accurate data using an electronic data entry 
system  
 Sites that will support on-site clinical data monitoring during the study   

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8.5 Justification for the Study Design 
The S-ICD Post Approval Study is designed to assess long term safety and effectiveness 
outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK 
subcutaneous electrode in a commercial clinical setting.  As such, it is designed as a 
standard of care registry that will compare observed measures of safety and effectiveness 
at 5 years to performance goals that were derived from the same endpoints observed at 
shorter time periods (e.g., 1 year) in the S-ICD Clinical Investigation (IDE G090013).  
The S-ICD Post Approval Study will also provide an active reporting mechanism for 
close monitoring of device performance during the initial US commercialization, 
permitting characterization of low-frequency adverse events. 
9. 
SUBJECT ACCOUNTABILITY 
9.1 Point of Enrollment 
A participant in the S-ICD Clinical Investigation (IDE G090013) who is implanted with 
the S-ICD System is considered enrolled upon signing the informed consent form (ICF).  
Subjects who did not participate in the S-ICD Clinical Investigation (IDE G090013) will 
be considered enrolled after both signing an informed consent and undergoing an implant 
procedure.   A subject who signs an informed consent, but does not undergo an implant 
procedure does not count toward the enrollment ceiling and has no follow-up 
requirements. 
9.2 
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. 

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10. 
STATISTICAL CONSIDERATIONS 
 
The S-ICD Post Approval Study is designed to examine the long-term safety and 
effectiveness of the S-ICD System.  The study design includes two co-primary endpoints 
maintaining a family-wise significance level of 0.05 by defining a hierarchical testing 
procedure.  The safety endpoint will be tested first.  If the test is successful  then the 
effectiveness endpoint will be tested at the same significance level.  Primary endpoints 
will be tested prior to testing the secondary endpoints.  Individual rates of each adverse 
event contributing to the primary safety endpoint will be examined including two-sided 
95% exact confidence intervals.  Other pre-specified observational analyses are defined to 
further investigate the long-term safety and effectiveness of the S-ICD System.   
Subjects from the IDE study who provide informed consent for this study will be 
followed through 60 months post implant.  All subjects enrolled in the S-ICD System 
Clinical Investigation (IDE G090013) who underwent an implant attempt will contribute 
to the analyses of the safety and effectiveness endpoints and additional analyses.  Data 
from IDE subjects who do not provide consent for the study or subjects who previously 
exited the IDE will be censored at the time of IDE study exit in the endpoint analyses, but 
will not count toward the target enrollment sample size.  All non-IDE subjects who 
undergo an implant procedure for the S-ICD System will be included in the endpoint 
analyses and will count toward the enrollment ceiling.  All analyses may be done 
separately on IDE study subjects vs de novo implants.  The statistical analyses related to 
this study will be executed by the sponsor and/or business partners working on behalf of 
the sponsor. 

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10.1 Primary Safety Endpoint 
The primary safety endpoint of the study is defined as the Type I Complication Free Rate 
at 60 months (1800 days).  Type I complications are adverse events caused by a 
component (i.e. pulse generator, electrode, EIT or programmer) of the S-ICD System that 
results in permanent loss of device function,27 invasive intervention or death. 
10.1.1 Primary Safety Endpoint Performance Goal 
As of May 2012, safety data for the S-ICD System had been collected from 321 subjects 
implanted during the S-ICD System Clinical Investigation Study (IDE G090013) with 
mean implant duration of 13.5 ± 5.4 months and cumulative implant duration of 4331 
months.  The Type I Complication Free Rate at 12 months was 97% using Kaplan-Meier 
methods.  Assuming annual incidence of Type I complication of 3% in year 2 and 2% in 
years 3-5, the estimated Type I Complication Free Rate at 60 months would be 88.0%.  
Given an acceptable 3% uncertainty for the statistical estimate, the primary safety 
endpoint performance goal is 85.0%. 
10.1.2 Primary Safety Endpoint Hypothesis 
The primary safety endpoint null and alternative hypotheses are as follows: 
Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the 
performance goal of 85.0%. 
Ho: p1 ≤ 85.0% 
Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance 
goal of 85.0%. 
Ha: p1 > 85.0% 
 
27 Permanent loss of device function refers to: 1) the permanent loss of shock therapy and/or post shock pacing; 
 2) permanent loss of appropriate sensing in all available sensing configurations (oversensing that results in 
persistent inappropriate shocks or undersensing that could lead to undetected arrhythmias).  Loss of device 
function includes programming the PG permanently off or temporarily off in advance of an explant/revision. 

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The null hypothesis will be rejected if the lower one-sided 95% confidence bound28 of the 
Kaplan-Meier estimate, using the Peto method for standard error, exceeds the 
performance goal of 85.0%. 
10.2 Secondary Safety Endpoint 
The secondary safety endpoint of the study is defined as the Electrode-Related 
Complication Free Rate at 60 months. A complication is an adverse event that results in 
permanent loss of device function, invasive intervention or death. Electrode relatedness is 
defined in section 10.2.1.  
10.2.1 Secondary Safety Endpoint Related Adverse events 
The following complications occurring ≤ 30 days after initial implant will be included in 
the secondary safety endpoint analysis if determined to be attributable to structural 
electrode failure OR occurring > 30 days after implant regardless of cause: 
 Electrode movement (>5 cm) 
 Electrode impedance out of range 
 Electrode conductor fracture 
 Electrode deformation and/or breakage 
 Electrode insulation failure 
 
The following complications occurring > 30 days after initial implant will be included in 
the secondary safety endpoint analysis if determined to be attributable to a structural 
electrode failure: 
 Incomplete/improper electrode-header connection 
 In-subject damage to electrode (e.g., accidental cut to electrode body during 
pocket revision, PG replacement, etc.) 
 Electrode revisions to optimize therapy 
 Electrode movement  
 Infection 
 Oversensing 
 Undersensing
 
28 Using the Peto estimate for the standard error. 

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10.2.2 Secondary Safety Endpoint Performance Goal 
As of May 2012, safety data for the S-ICD System had been collected from 321 subjects 
implanted during the S-ICD Clinical Investigation Study (IDE G090013) with mean 
implant duration of 13.5 ± 5.4 months and cumulative implant duration of 4331 months.  
The Electrode-Related Complication Free Rate at 12 months was 98.7% using Kaplan-
Meier methods.  Assuming an additional 4.2% electrode related complication rate for the 
next 48 months, the estimated Electrode Related Complication Free Rate at 60 months 
would be 94.5%.  Given an acceptable 2% uncertainty for a statistical estimate, the 
primary safety endpoint performance goal is 92.5%. 
10.2.3 Secondary Safety Endpoint Hypothesis 
The primary safety endpoint null and alternative hypotheses are as follows: 
Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the 
performance goal of 92.5%. 
Ho: p1 ≤ 92.5% 
Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the 
performance goal of 92.5%. 
Ha: p1 > 92.5% 
The null hypothesis will be rejected if the lower one-sided 95% confidence bound29 of the 
Kaplan-Meier estimate using the Peto method for standard error exceeds the performance 
goal of 92.5%. 
10.2.4 Individual Estimates for Secondary Safety Endpoint Related 
Events  
In addition to the composite estimate of electrode related complications, individual rates 
of each adverse event category contributing to the primary safety endpoint will be 
examined including two-sided 95% exact confidence intervals. 
 
29 Using the Peto estimate for the standard error. 

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10.3 Primary Effectiveness Endpoint 
The primary effectiveness endpoint of the study is defined as the Overall Shock 
Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 
months.  Overall shock effectiveness refers to conversion of an episode following on any 
of the 5 shocks (maximum) that may be delivered during a single episode.  Discrete 
episodes of VT/VF are those that are temporally independent (<3 within a 24 hour 
period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour 
period).  Episodes that spontaneously terminate will be excluded from this endpoint since 
the effectiveness of the shock cannot be evaluated in such circumstances. 
10.3.1 Primary Effectiveness Endpoint Performance Goal 
As of May 2012, safety data for the S-ICD System had been collected from 321 subjects 
implanted during the S-ICD Clinical Investigation Study (IDE G090013) and a total of 45 
discrete spontaneous episodes of VT/VF were collected.  Two (2) discrete spontaneous 
episodes of VT/VF spontaneously converted before delivery of all 5 shocks, leaving 43 
evaluable spontaneous episodes.  All 43 (100%) were converted by a shock delivered by 
the S-ICD System.  Given the lack of precision because of the limited number episodes 
associated with this estimate, a 6% delta will be allowed for statistical uncertainty.  
Therefore, the primary effectiveness performance goal is 100%-6%= 94.0%. 
10.3.2 Primary Effectiveness Endpoint Hypothesis 
The primary effectiveness endpoint null and alternative hypotheses are as follows: 
Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF 
through 60 months (p1) does not exceed the performance goal of 94.0%. 
Ho: p1 ≤ 94.0% 
Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF 
through 60 months (p1) does exceed the performance goal of 94.0%. 
Ha: p1 >94.0% 
The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound 
of the estimate exceeds the performance goal of 94.0%.  

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10.4 Secondary Effectiveness Endpoint 
The secondary effectiveness endpoint of the study is defined as First Shock Effectiveness 
in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 
months.  Induced episodes following the initial implant procedure after enrollment (i.e., 
acute) will be counted towards the endpoint using the first shock delivered in the final 
position and final polarity.  Because VT/VF induction test shocks are expected to be 
delivered at an energy below 80 J (e.g., 65 J), poolability with spontaneous episode 
shocks (all delivered at 80 J, non-programmable) will be assessed for the primary 
analysis.  If the two data sets differ, separate analyses will be presented for first shock 
efficacy of induced episodes and first shock efficacy of spontaneous episodes. 
10.4.1 Secondary Effectiveness Endpoint Performance Goal 
As of May 2012, safety data for the S-ICD System had been collected from 321 subjects 
implanted during the S-ICD Clinical Investigation Study (IDE G090013) a total of 45 
discrete spontaneous episodes of VT/VF were collected.  Forty (40) out of the 45 
spontaneous discrete episodes of VT/VF were converted by the first shock delivered by 
the S-ICD System (89%, LCB95%=78.0%).  Given the lack of precision associated with 
this estimate, a 5% delta will be allowed for statistical uncertainty.  Therefore, the 
secondary effectiveness performance goal is 89%-5%= 84.0%. 
10.4.2 Secondary Effectiveness Endpoint Hypothesis 
The secondary effectiveness endpoint null and alternative hypotheses are as follows: 
Ho: The First Shock Effectiveness in Converting Induced (Acute) and Spontaneous 
Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance 
goal of 84.0%. 
Ho: p1 ≤ 84.0% 
Ha: The First Shock Effectiveness in Converting Induced (Acute) and Spontaneous 
Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 
84.0%. 
Ha: p1 >84.0% 
The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of 
the estimate exceeds the performance goal of 84.0%.  

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10.5 Additional Pre-Specified Effectiveness Analyses 
Other effectiveness objectives that will be collected and analyzed are as follows: 
 Implant test analysis (induced episode VT/VF conversion, VT/VF detection 
sensitivity and time to therapy) 
 Spontaneous episodes of VT/VF 
o Incidence 
o Rhythm and rate 
o Time to therapy (treated episodes only) 
o Conversion rate for spontaneous VT/VF storms 
10.6 Sample Size Determination 
The MINITAB software, version 14.0 was used to calculate the sample size in this study. 
The analysis cohort is sized to provide at least 80% power for all primary and secondary 
endpoints analyses using a one-sided 5% significance level.  Additionally, the sample size 
is selected to ensure the two-sided upper 95% confidence bound of an assumed event rate 
of 0.4% is within 1% for the each adverse event category contributing to the primary 
safety endpoint adverse events. 
Based on these objectives, the minimum analysis cohort required is 1,025 subjects.  This 
sample size would provide adequate statistical power for all primary and secondary 
endpoint sequential analyses. 
10.6.1 Target Sample Size 
The one-year attrition rate in the IDE study was 8.7% (28/321).  The attrition rate for the 
post-approval study is expected to be similar, therefore the assumed annual attrition rate 
is 8.7%.  Considering attrition, the required target sample size to obtain 1,025 subject in 
the analysis cohort is 1,616 subjects who undergo an implant procedure. 

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10.7 Data Analysis 
10.7.1 Safety Endpoint Analyses 
The primary safety endpoint will be evaluated as the proportion of subjects free from 
Type I Complication at 60 months based on the Kaplan-Meier method including the one-
sided lower 95% confidence interval.30  
The secondary safety endpoint will be evaluated as the proportion of subjects free from 
Electrode Related Complication at 60 months based on the Kaplan-Meier method 
including the one-sided lower 95% confidence interval.30 
The Kaplan-Meier analysis will take into account the time from implant until the 
occurrence of the complication and data from any subjects who are complication-free will 
be right censored at the last known follow-up including subjects who exited the study. 
10.7.2 Individual Adverse events Analyses 
Individual rates of each adverse event category contributing to the primary and secondary 
safety endpoints will be examined using the binomial estimate including the two-sided 
95% exact confidence intervals. 
10.7.3 Additional Pre-Specified Safety Analyses 
The appropriate statistical methods will be utilized to evaluate the additional pre-specified 
analyses listed in section 6.6 including: 
 Kaplan-Meier method for time to event analyses 
 Binomial estimates and exact confidence intervals for rates 
 Descriptive statistics such as mean, standard deviation, median, interquartile 
range, minimum and maximum for continuous data and frequency and percentage 
for discrete data. 
10.7.4 Effectiveness Endpoint Analyses 
The primary effectiveness endpoint of overall shock effectiveness for spontaneous 
discrete episodes of VT/VF will be examined using the binomial estimate including the 
one-sided 95% lower exact confidence bound. 
 
30 Peto method for standard error estimate 

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The secondary endpoint of first shock effectiveness for acute and spontaneous discrete 
episodes of VT/VF will be examined using the binomial estimate including the one-sided 
95% lower exact confidence bound.  If the difference in first shock effectiveness rate for 
the acute and spontaneous episodes is statistically significant at a 0.05 significant level 
using a chi-square test then separate analyses will be presented for first shock efficacy of 
induced and spontaneous episodes. 
10.7.5 Additional Pre-Specified Effectiveness Analyses 
Descriptive statistics such as mean, standard deviation, median, and ranges for continuous 
data and frequency and percentage for discrete data will be utilized to analyze the 
additional pre-specified effectiveness data listed in section 10.5. 
10.7.6 Baseline and Procedural Experience Analyses 
Demographics and baseline clinical variables, including but not limited to relevant 
descriptors from the medical history, risk factors, co-morbidities, NYHA functional class 
for heart failure and medications will be summarized for the cohort of subjects enrolled in 
this study.  Continuous variables will be summarized as means, standard deviations, 
medians and ranges.  Categorical variables will be summarized as frequencies or 
percentages.  A summary of the eligibility status of enrolled subjects will be performed.  
Also outcomes related to the S-ICD System procedure such as, but not limited to, type of 
anaesthesia, implant duration, use of fluoroscopy or X-ray for system positioning, length 
of hospital stay and use of dual zone programming and rate cut-offs will be summarized. 
10.7.7 Poolability Analysis 
Poolability analysis for both primary safety and effectiveness endpoint will be analyzed.  
The effect of type of investigational site (academic/community vs. private hospital) and 
the implanting size of investigational sites (high vs. low implants) will be analyzed for 
poolability. The log-rank test is a commonly used non-parametric test for categorical 
predictor variables that compares the shapes of the Kaplan-Meier curves and tests 
whether or not the survival between groups are proportional (curves are approximately 
parallel). The log-rank test will be utilized to determine any relevant difference in 
Kaplan-Meier curves with the primary safety endpoint. A chi-square test will be used to 
analyze the difference in overall shock effectiveness rate for the primary effectiveness 
endpoint.  

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10.7.8 Sensitivity Analysis 
Every effort will be utilized to minimize missing data.  The denominator for each variable 
and all analyses will be presented in each report.  The number of subjects withdrawing 
from the study will be presented with the corresponding time of discontinuation.  Time-
to-event drop-outs will be censored, consistent with the Kaplan-Meier approach.  A 
sensitivity analysis for the primary safety endpoint will be performed to analyze the 
possible impact of the missing data.  The primary safety endpoint rate for subjects 
remaining in the study will be applied to subjects lost to attrition.  Primary safety 
endpoint related events will be randomly assigned to subjects lost to attrition to avoid bias 
in early vs. late drop outs.  The revised primary safety endpoint rate will then be 
compared with the objective performance goal. 
10.7.9 Subgroup Analysis 
Subgroup analyses of safety and effectiveness endpoints will be performed for key 
baseline/demographic characteristics according to the matrix shown in Table 11.  
Continuous variables will be dichotomized for analysis.  For time to event outcomes, the 
log-rank test will be utilized to compare the shapes of the Kaplan-Meier curves and tests 
whether or not the survival between groups are from the same distribution. A chi-square 
test or Fisher Exact test as appropriate will be used to analyze the differences on non-time 
dependent outcomes. 

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Table 11: Variable matrix summarizing subgroup analyses 
 
Subgroup 
Variables 
Outcomes 
1o and 2o 
Effectiveness 
Endpoints 
1o and 2o 
Safety 
Endpoints 
System 
Revisions and 
Removals 
Inappropriate Shocks 
Infection Discomfort
All 
Causes
Sensing
SVT 
Age 
X 
X 
X 
X 
X 
X 
X 
X 
Race 
X 
X 
X 
 
 
 
 
 
Gender 
X 
X 
X 
X 
X 
X 
X 
X 
BMI 
X 
X 
X 
X 
X 
X 
X 
X 
NYHA Class 
X 
X 
X 
X 
X 
X 
X 
X 
Indication 
X 
X 
X 
X 
X 
X 
X 
X 
EF 
X 
X 
X 
X 
X 
X 
 
 
MI 
X 
X 
X 
X 
X 
X 
 
 
Height 
X 
X 
X 
X 
X 
X 
 
X 
Shock Zones 
 
 
 
X 
X 
X 
 
 
Diabetes 
 
X 
X 
 
 
 
X 
X 
Creatinine 
X 
X 
X 
X 
X 
X 
X 
 
Prior TV 
Device 
X 
X 
X 
 
 
 
X 
X 
Antiplatelet/ 
Anticoagulation
 
X 
X 
 
 
 
X 
 
10.8 Reports 
At a minimum, an annual report to the FDA will be provided by the sponsor summarizing 
the following: enrollment and implant status, device usage including out of service 
devices, protocol deviations, baseline characteristics, procedural data, reported adverse 
events, unanticipated adverse device effects, deaths, number of spontaneous episodes of 
VT/VF and corresponding conversion results. 
10.9 Additional Pre-specified Analyses 
Descriptive statistics will be used to further characterize the performance of the S-ICD 
System. Additional pre-specified analyses will include, but are not limited to, the 

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additional safety analyses listed in section 6.6, additional effectiveness analyses listed in 
section 10.5 and the following: 
 Clinical Indications for implant 
 Demographics and baseline characteristics of the implant population 
 Whether subject was a candidate for a TV-ICD and reason for S-ICD System 
implantation  
 Type of anesthesia/analgesia 
 Management of antiplatelet and anticoagulation medications during implant 
 Use of medical imaging during implant 
 Programmed settings 
 Use of dual zone programming and rate cutoffs 
10.10 Other Statistical Considerations 
Confidence intervals and statistical tests will be performed at a two-sided 5% significance 
level unless specified otherwise.  All p-values will be rounded to three decimal places.  If 
opportunities should arise, data mining and modelling analyses of the study may be 
utilized for publication and/or medical conference presentation purposes as long as the 
integrity and objectives of the study are not compromised.   
11. 
ADVERSE EVENTS 
11.1 Adverse event Reporting 
All adverse events related to the S-ICD System must be reported to the sponsor.  An 
adverse event should not be reported if it was considered a pre-existing medical condition 
or a non-cardiovascular related event clearly unrelated to the S-ICD System or procedure.  
In addition, events in which there is no untoward clinical occurrence in the subject should 
not be reported.   
Investigators must report clinical events to the sponsor as described in Table 12. 
Table 12: Investigator Reporting Timelines for Deaths and Clinical Events 
Event Type 
Reporting Time 
Death and all 
SA(D)Es
As soon as possible, but no later than 2 working days after 
becoming aware
Reportable Adverse 
Device Effect
As soon as possible, but no later than 10 working days after 
becoming aware
Device Deficiencies 
As soon as possible, but no later than 1 working day after 
becoming aware
 

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Examples of events that do not require reporting include: 
 Follow-up or exacerbation/worsening of pre-existing conditions including: 
diabetes, cancer, allergies, osteoporosis, arthritis, heart failure, etc. 
 New medical conditions unrelated to the S-ICD System including: diabetes, 
cancer, allergies, osteoporosis, arthritis, etc. 
 Physical trauma or injury unrelated to the S-ICD System including: 
musculoskeletal injuries, joint aches and pains, tendonitis, bursitis or burns from 
external causes. 
 Rotation of the pulse generator in which the subject experiences no discomfort or 
other untoward clinical occurrence. 
 Device explant or replacement in the absence of any untoward medical 
occurrence, including normal battery depletions 
 Adverse events or sequelae related to a different procedure or separate medical 
device, such as a concomitant pacemaker or abandoned/extracted lead 
 Normal battery depletion 
 Inability to implant the device (e.g., due to high DFTs) 
If it is unclear whether or not an event should be reported, investigators should 
conservatively report the event.   
11.2 Adverse event Definitions 
Adverse event – Any untoward medical occurrence in a subject.  This definition does not 
imply that there is a relationship between the event and the system under investigation. 
Adverse Device Effect - Any untoward or unintended response to a medical device. This 
definition includes any event resulting from insufficiencies or inadequacies in the 
instructions for use or deployment of the device. It also includes any event that is a result 
of user error. 
Serious Adverse Event – An adverse event that: 
 Led to a death; 

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 Led to a serious deterioration in the health of the subject that: 
o resulted in a life-threatening illness or injury, 
o resulted in a permanent impairment of a body structure or a body 
function, 
o required in-subject hospitalization or prolongation of existing 
hospitalization, 
o resulted in medical or surgical intervention to prevent permanent 
impairment to body structure or a body function; 
 Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Serious Adverse Device Effect- An adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event or that might have led to any of 
these consequences if suitable action had not been taken or intervention had not been 
made or if circumstances had been less opportune. 
Observation – An adverse event that does not result in invasive intervention.  Examples 
of such non-invasive intervention include, system reprogramming, antibiotic treatment of 
pocket infection, or change in medications. 
Complication – An adverse event that results in permanent loss of device function,31 
invasive intervention or death.  
11.3 Classification of Adverse events 
All adverse events will be categorized as observations or complications based on the 
intervention required to resolve the adverse event.  A complication is an adverse event 
that results in permanent loss of device function, invasive intervention or death. 
All adverse events will also be classified by type based on the cause of the adverse event.  
The following definitions for adverse event types will be used: 
 Type I: Caused by a component of the S-ICD System, including the pulse 
generator, electrode, electrode insertion tool or programmer 
 
31 Permanent loss of device function refers to: 1) the permanent loss of shock therapy and/or post shock pacing; 
 2) permanent loss of appropriate sensing in all available sensing configurations (oversensing that results in 
persistent inappropriate shocks or undersensing that could lead to undetected arrhythmias).  Loss of device 
function includes programming the PG permanently off or temporarily off in advance of an explant/revision. 

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 Type II: Other adverse events not specifically caused by a component of the S-
ICD System, but would not have occurred in the absence of the implanted S-ICD 
System 
 Type III: Caused by a change in the subject’s condition 
 Type IV: Pre-existing medical condition or occurred while the subject was not 
enrolled  
Adverse events will typically be labelled and categorized according to the clinical 
presentation, including device malfunctions. 
In the event of a subject death, the S-ICD System should be interrogated, removed from 
the subject, and returned to BSC for analysis.  The data related to the death should be 
recorded in the database in a timely fashion.  A detailed death letter should also be 
provided to the sponsor. 
In the event that the SQ-RX pulse generator or Q-TRAK subcutaneous electrode cannot 
be removed, the SQ-RX pulse generator should be interrogated prior to interment.  Note 
that failure to remove the S-ICD System from a deceased subject prior to cremation may 
cause the battery to explode when the device is exposed to extreme temperatures. 
All subject deaths will be reported by the sponsor to the appropriate regulatory agencies. 
11.4 Device Deficiencies 
A device deficiency is defined as an inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, misuse or use 
error and inadequate labelling. 
12. 
ELECTRONIC CASE REPORT FORM DATA COLLECTION 
All study data will be entered into electronic case report forms (CRFs) that are located on 
the study’s electronic data capture system (EDC). Data can be recorded on a worksheet 
and then entered electronically. Alternatively, CRF data can be directly entered 
electronically. Either worksheets or information from subjects’ medical charts serve as 
source documentation for electronically entered data.  Site personnel are required to 
conduct an active subject chart review (e.g., implant, pre-discharge and any subsequent 
follow-up) to ensure the capture of possible acute adverse events during and between 
visits. Upon thorough review of subject chart, center personnel are asked whether adverse 

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events are identified by answering a designated questionnaire on the corresponding case 
report form and to verify whether any of the reportable adverse events as described in 
section 11 have occurred. 
12.1 Enrollment Form 
An Enrollment Form is completed when a subject has completed their Enrollment visit 
and all required data collection is complete as outlined in section 7.2.3.  
12.2 Implant Form 
An Implant Form is completed when a subject has completed their Implant visit and all 
required data collection is complete as outlined in section 7.2.6. 
12.3 Pre-Discharge Form 
A Pre-Discharge Form is completed when pre-discharge data collection is complete as 
outlined in section 7.2.8. 
12.4 Annual Follow-up Visit Form 
An Annual Follow-up Visit Form is completed when a subject has completed their annual 
visit and all required data collection is complete as outlined in section 7.2.9.  
12.5 Additional Follow-up Visit Form 
An Additional Follow-up Form is completed when a subject completes an additional visit 
that meets the definition of an additional follow-up visit and all required data collection is 
complete as outlined in section 7.2.10  
12.6 Revision, Replacement and Explant Forms 
In the event that the electrode or PG are surgically revised after the initial implant 
procedure, the appropriate revision forms are used to record changes to the system and all 
data required as outlined in section 7.3.  
12.7 Study Completion Form 
A Study Completion Form is completed when a subject has exited the study for any 
reason and all required data collection is complete as outlined in section 7.4.  

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12.8 Protocol Deviations 
This is a standard of care registry.  Deviations will only be issued for the following 
events: 
 Inappropriate or unavailable informed consent 
 Inclusion/exclusion criteria violations 
 Failure to obtain required data 
 
13. 
SUBJECT INFORMED CONSENT 
Subject participation in this clinical study is voluntary.  Informed Consent is required 
from all subjects or their legally authorized representative. Informed consent is required 
from all subjects or their legal representative, prior to participation in this study.  The 
sponsor will provide a template informed consent document in local language.  For sites 
where IRB approval is required, the informed consent should also be approved. In the 
event no IRB approval is required, the final version of the informed consent will be 
agreed between the sponsor and the investigational center.  Significant changes to the 
consent document provided by the sponsor may need to be reviewed and approved by the 
sponsor before a subject provides written informed consent. Boston Scientific will 
provide study-specific template of the Screening ECG ICF and S-ICD PAS ICF to 
investigators participating in this study. The ICF templates may be modified to meet the 
requirements of the investigative center’s IRB/EC.  Any modification requires approval 
from BSC prior to use of the form.  The ICFs must be in a language understandable to the 
subject and if needed, BSC will assist the center in obtaining a written consent translation. 
Translated ICFs must also have IRB/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 Investigator is responsible for ensuring that Informed Consent is obtained prior to 
data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, 
and local Ethics Committee and/or Regulatory authority body, as applicable. The ICF 
must be approved by the center’s IRB/EC, or central IRB, if applicable. 

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A Screening/Enrollment Log will be maintained to document select information about 
candidates who fail to meet the entry criteria.  For subjects with a failed ECG screening 
test, the ECG may be collected only if a separate “Screening ECG” ICF is signed by the 
subject.  This Screening ECG ICF allows collection of the screening ECG only and does 
not enroll the subject in the study.  A separate “S-ICD PAS” ICF will be used to enroll 
subjects in the study. 
The process of obtaining Informed Consent shall: 
 be conducted by the Principal Investigator or designee authorized to conduct the 
process,  
 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 ICFs shall always be signed and personally dated by the subject or legal 
representative and by the investigator or an authorized designee responsible for 
conducting the informed consent process. 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 ICFs will be retained by the center 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 (e.g., FDA requirement is within 5 working days of 
learning of such an event). Any violations of the informed consent process must be 

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reported as deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), 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 IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Boston Scientific approval is required if changes to the revised ICF are 
requested by the center’s IRB/EC. The IRB/EC will determine the subject population to 
be re-consented. 
  
14. 
INSTITUTIONAL REVIEW BOARD 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB is registered or that registration has been 
submitted to the appropriate agency, as applicable according to national/regulatory 
requirements.   
A copy of the written IRB of the protocol 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 IRB approval and renewals will be obtained throughout the duration of the study 
as required by IRB requirements. Copies of the Investigator’s reports and the IRB 
continuance of approval must be provided to the sponsor.  
15. 
CONFIDENTIALITY AND RISK ANALYSIS 
15.1 Subject Confidentiality 
Subject data will be treated as confidential information by the sponsor.  The sponsor will 
limit access to confidential information to those individuals requiring access.  Regulatory 
agencies maintain the right to review records pertinent to this clinical study.  Unless 

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required by law, the sponsor will report de-identified data in an effort to secure subject 
confidentiality. 
15.2 Health Insurance Portability and Accountability Act (HIPAA) 
The HIPAA requirements affect clinical trials in three key areas as described below: 
Accounting of Disclosures:  Data collected during the conduction of pre-screening 
activities for this study are subject to the HIPAA accounting of disclosures’ regulations. It 
is the responsibility of the investigative center to tell all subjects whose records were 
screened for eligibility in the study that their records were used in this manner if he or she 
requests an accounting of when his or her data were disclosed.   
Consent:  All subjects participating in the study will be made aware that their 
participation in the study will involve disclosure of certain protected health information to 
BSC and for what purpose. The ICF will contain a listing of the type of information that 
will be disclosed during the course of the clinical study.  
Withdrawal of Consent:  HIPAA specifically allows companies such as BSC that are 
subject to the jurisdiction of the FDA access to protected health information for activities 
related to the quality, safety or effectiveness of devices. This means that BSC can use 
data from this study even if the individual withdraws his or her authorization. 

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15.3 Analysis of Risks 
A complete list of anticipated cautions, warnings and potential adverse events is included 
in the User Manual.   
Potential adverse events related to implantation of the S-ICD System may include, but are 
not limited to, the following: 
• Acceleration/induction of atrial or 
ventricular arrhythmia  
• Adverse reaction to induction testing 
• Allergic/adverse reaction to system or 
medication 
• Bleeding 
• Conductor fracture 
• Cyst formation 
• Death 
• Delayed therapy delivery 
• Discomfort or prolonged healing of 
incision 
• Electrode deformation and/or breakage 
• Electrode insulation failure 
• Erosion/extrusion 
• Failure to deliver therapy 
• Fever 
• Hematoma 
• Hemothorax 
• Improper electrode connection to the 
device 
 Inability to communicate with the 
device  
 Inability to defibrillate or pace 
 Inappropriate post-shock pacing 
 Inappropriate shock delivery 
 Infection 
 Keloid formation 
 Migration or dislodgement 
 Muscle stimulation 
 Nerve damage 
 Pneumothorax 
 Post-shock/post-pace discomfort 
 Premature battery depletion 
 Random component failures 
 Stroke 
 Subcutaneous emphysema 
 Surgical revision or replacement of 
the system 
 Syncope 
 Tissue redness, irritation, numbness 
or necrosis
 
If any adverse events occur, invasive corrective action and/or S-ICD System modification 
or removal may be required. 
Subjects who receive an S-ICD System may develop psychological disorders that include, 
but are not limited to, the following: 
• Depression 
• Fear of shocks 
• Phantom shocks 
 

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15.4 Risk Minimization 
Risks associated with the S-ICD System can be minimized by following the detailed 
instructions in the User’s Manual. 
15.5 Potential Benefits 
This clinical evaluation is intended to evaluate long term clinical outcome associated with 
the S-ICD System.  The S-ICD System does not require any component of the system to 
be placed in the vasculature or the heart, and therefore, eliminates risks and complications 
associated with transvenous lead placement. 
16. 
COMPLIANCE 
16.1 Statement of Compliance 
This study will be conducted in accordance with the relevant parts of the ICH Guidelines 
for Good Clinical Practices and ethical principles that have their origins in the 
Declaration of Helsinki, and pertinent laws and regulations. The study shall not begin 
until the required approval/favorable opinion from the IRB.  Any additional requirements 
imposed by the IRB or regulatory authority shall be followed, if appropriate. 
16.2 Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the monitor verifies that 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. The Investigator/institution 
guarantees direct access to original source documents by BSC personnel, their designees, 
and appropriate regulatory authorities. 
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.  Monitoring activities may 
include: 
 Review of Informed Consent documentation; 
 Review/maintenance of medical records and source documents; 

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 Verification of subject eligibility requirements as stated in the clinical protocol; 
 Review of case report forms and data clarifications/queries; 
 Review of IRB or EC requirements, reports and correspondence; 
 Review of study records and correspondence; 
 Verification that personnel with trial related responsibilities have been trained 
prior to conducting study activities. 
 Evaluation of facilities; 
 
Should BSC determine that an investigator is not complying with the signed investigator 
agreement, this protocol, other applicable FDA regulations, or any conditions of approval 
imposed by the reviewing IRB or FDA, BSC shall promptly either secure compliance or, at 
its sole discretion, terminate the investigator's participation in the investigation. 
16.3  Complaint Reporting and Return of S-ICD Systems 
In the event that any product needs to be returned due, for example to explant or 
perceived malfunction, or to report a complaint or product experience, the contact 
information for Cameron Health/BSC Customer Service is as follows: 
US Customer Service 
Telephone:
1-949-498-5630 
Free:
1 800 227 3422 
1 800 CARDIAC 
Fax:
1-949-498-5932 
Email:
customerservice@cameronhealth.com 
 

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16.4 Securing Compliance 
The sponsor is responsible for ensuring investigator compliance with the clinical protocol, 
the investigator agreement and applicable regulatory requirements.  The sponsor will 
attempt to secure compliance by discussing the non-compliance and the corrective action 
with investigators in person, on the telephone, or in writing.  The sponsor reserves the 
right to terminate investigators’ participation for continued non-compliance. 
16.5 Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by 
BSC for subjects in the study will be obtained. 
17. 
RESPONSIBILITIES 
17.1 Sponsor Responsibilities and Contact Information 
The sponsor is responsible for selecting qualified investigators and providing them with 
the information they need to conduct the investigation properly, ensuring appropriate 
monitoring of the investigation, ensuring that IRB review and approval are obtained as 
required and ensuring that any reviewing IRB or Regulatory Agency is promptly 
informed of significant new information about an investigation. 
Questions regarding this study should be directed to the local sponsor representative or 
designee. 
17.2 Role of Sponsor Field Clinical Engineers 
BSC personnel can provide technical assistance to the investigator and other health care 
personnel as needed during enrollment, implant, conversion testing, and follow-up visits. 
Assistance may include training, assistance with data entry, addressing questions, or 
providing clarification concerning the operation of the S-ICD System, procedures or 
testing described in this protocol, or the case report forms. 
At the request of the investigator and while under their supervision, BSC personnel may 
operate equipment during enrollment, implant, conversion testing or follow-up visits and 
interact with the subject to accomplish the requested activities.  

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BSC personnel will not: 
 
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 or other health care personnel 
17.3 Investigator Responsibilities 
Investigators are responsible for the following: 
 
Ensuring that the study is conducted according to any signed agreements, the 
Protocol and applicable regulations for protecting the rights, safety, and 
welfare of subjects under the investigator's care 
 
Ensuring that the study is conducted with the express approval of the 
Institution’s IRB or providing appropriate documentation that such approval is 
not required 
 
Ensuring that conducting the study will not give rise to conflicts of interest 
 
Informing the sponsor in writing of the reason(s) for any withdrawal of any 
IRB approval  
 
Ceasing the enrollment of subjects immediately in the event of the withdrawal 
of any IRB approval  
 
Ensuring that no subjects will be enrolled, without prior, written Approval to 
Enroll from the Sponsor  
 
Agreeing to use their best efforts to satisfactorily complete the planned work 
and to comply at all times with accepted good clinical practice. 
 
Informing the sponsor of any conditions under which prior research was 
terminated  
 
Ensuring that informed consent is obtained appropriately and that the 
conditions of informed consent are complied with 
 
Ensuring the appropriate completion of all case report forms with the 
understanding that certain records and reports may be submitted to regulatory 
agencies by the Sponsor to support regulatory submissions  
 
Maintaining all records as described in the Protocol 
 
Supporting a monitor/auditor (as applicable) in their activities  

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 
Informing the Sponsor of all adverse events and adverse device effects in a 
timely manner and informing the IRB of any serious adverse device effects as 
applicable 
17.4 Selection of Investigators 
Investigators will be Board Certified Electrophysiologists and Cardiologists with 
transvenous ICD implant experience who have expressed willingness to adhere to the 
investigational plan and provide all required data on a timely basis. 
17.5 Enrollment Commencement Requirements 
Investigators will be required to submit the following documents to the Sponsor prior to 
the first subject enrollment: 
 Current curriculum vitae of investigator and co-investigators; 
 Signed Clinical Trial Agreement or equivalent 
 Signed Financial Agreement (separate or incorporated with a clinical trial 
agreement)  
 Documentation that the study has obtained appropriate IRB approval or 
that such approval is not required 
 Approved Subject Informed Consent Form (ICF) 
 Financial Disclosure; and 
 IRB roster, Multiple Project Assurance (MPA) number or Federal Wide 
Assurance (FWA) 
 
The principal investigator at each investigational center is responsible for the proper conduct 
of the trial at the center.  Some responsibilities may be assigned to co-investigators or other 
appropriately trained personnel, at the clinical center; however, the principal investigator 
remains responsible for the proper conduct of the clinical investigation.

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18. 
RECORDS AND REPORTING  
Case Report Forms should be submitted within 10 business days after the corresponding 
visit.  However, adverse events and deaths should be reported according to the timelines 
shown in Table 12. Investigators are responsible for notifying the sponsor of any changes 
to previously reported data. 
Original source documentation must be maintained at the investigational center to 
substantiate data entered on case report forms.  Source data must be made available by the 
investigator to facilitate monitoring, as described in section 16.1.  Specific source 
document requirements are included throughout section 7.2. 
Interim progress reports will be generated every 6 months for the first two years of the 
study and annually thereafter from the negotiated start date for the study.  Reports will 
include sections outlined in the relevant FDA guidance documents pertaining to post 
approval studies. 
18.1 Investigator Records 
Investigators are required to maintain complete and accurate records pertaining to the 
study.  Relevant records include: 
 
IRB approvals, renewals, and withdrawals; 
 
Records of systems used in the study, including traceability to the subject that 
received the system; 
 
Records of any systems returned to the sponsor; 
 
Signed informed consent form(s) for each enrolled subject; 
 
Completed case report forms; 
 
Records of all adverse events and supporting documentation; 
 
Records pertaining to the death of any subject participating in the study; 
 
Copies of the current approved version of the protocol. 
Records should be maintained for at least 3 years following the completion or termination 
of the investigation or the time dictated by national guidelines if longer. 

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18.2 Amendments to the Protocol 
In the event an amendment to the protocol is required, the sponsor will inform all 
Principal Investigators in writing including an explanation of any reason for change. 
Subjects may not be enrolled according to the requirements of any amendment until 
appropriate approval is obtained including the IRB approval as required. 
19. 
COMMITTEES 
19.1 Clinical Events Committee 
A Clinical Events Committee (CEC) is an independent group of individuals with pertinent 
expertise that reviews and adjudicates important endpoints and relevant adverse events 
reported by study investigators. 
Committee membership will include experts with the necessary therapeutic area and subject 
matter expertise to adjudicate adverse events. CEC responsibilities, qualifications, 
membership, and committee procedures will be outlined in a CEC charter. 
20. 
SUSPENSION OR TERMINATION 
20.1 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 IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 

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20.2 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
 The occurrence of unanticipated adverse device effects that present a significant 
or unreasonable risk to subjects enrolled in the study. 
 An enrollment rate far below expectation that prejudices the conclusion of the 
study.  
 A decision on the part of Boston Scientific to suspend or discontinue development 
of the device. 
20.3 Termination of Study Participation by the Investigator or 
Withdrawal of IRB/ EC Approval 
Any investigator, or IRB/ EC may discontinue participation in the study or withdrawal 
approval of the study, respectively, with suitable written notice to Boston Scientific. 
Investigators, associated IRBs/ECs, and regulatory authorities, as applicable, will be notified 
in writing in the event of these occurrences. 
20.4 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 centers by Boston Scientific. 
The IRB/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 IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/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 an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible. In the event there are no opportunities to transfer 
investigator responsibility; detailed information on how enrolled subjects will be managed 
thereafter will be provided by Boston Scientific. 
The investigator must return all documents and investigational product to Boston Scientific, 
unless this action would jeopardize the rights, safety, or welfare of the subjects. 

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20.5 Criteria for Suspending/Terminating a Study Center 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
center at any time after the study initiation visit if no subjects have been enrolled  for a period 
beyond 12 months after center initiation, or if the center has multiple or severe protocol 
violations/noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of investigator 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 IRB/EC and regulatory authorities, as 
applicable, should be notified. All subjects enrolled in the study at the center will continue to 
be followed according to the standard of care. The Principal Investigator at the center must 
make provision for these follow-up visits unless BSC notifies the investigational center 
otherwise. 
21. 
PUBLICATIONS POLICY 
In accordance with the Corporate Policy on the Conduct of Human Subject Research, 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. In accordance with the Corporate Policy 
for the Conduct of Human Subject Research, 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.  

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Appendix A 
Acronyms and Definitions 
bpm
beats per minute
CEC
Clinical Events Committee
CFR
Code of Federal Regulations
Adverse event 
Any untoward medical occurrence in a subject 
CRF
Case Report Form
Complication 
A complication is an adverse event that results in permanent loss of 
device function, invasive intervention or death.
ECG
Electrocardiogram
EIT
Electrode Insertion Tool
FCC
Federal Communications Commission
ERI
Elective Replacement Indicator
FCE
Field Clinical Engineer
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
GLP
Good Laboratory Practice
ICD
Implantable Defibrillator
ICF
Informed Consent Form
IRB
Institutional Review Board
J
Joules
LVEF
Left Ventricular Ejection Fraction
ms
Millisecond
N/A
Not Applicable
NNT
Number Needed to Treat
NR
Not Required
Normal Battery 
Depletion 
A pulse generator that is not associated with a complaint and has 
reached its elective replacement indicator(s) with implant time that 
meets or exceeds the nominal (50th percentile) predicted longevity 
at default (labelled) programmable settings OR with implant time 
exceeding 75% of the expected longevity using the longevity 
calculation tool available at time of product introduction, calculated 
using the device’s actual use conditions and programmable settings
NSR
Normal Sinus Rhythm
NYHA
New York Heart Association
Observation 
Observations are adverse events that do not result in invasive 
interventions.  Examples are reprogramming or medication change.
OUS
Outside the United States
PCMCIA
Personal Computer Memory Card International Association
PCr
Serum (Plasma) Creatinine Level
Permanent Loss of 
Device Function 
Refers to: 1) the permanent loss of shock therapy and/or post shock 
pacing; 2) permanent loss of appropriate sensing in all available 
sensing configurations (oversensing that results in persistent 
inappropriate shocks or undersensing that could lead to undetected 
arrhythmias). Loss of device function includes programming the PG 

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permanently off or temporarily off in advance of an 
explant/revision.
PMA
Premarket Approval
ppm
pulses per minute
RF
Radio Frequency
SAS
Statistical Analysis System
Spontaneous Episode
Any arrhythmia that is stored by the SQ-RX pulse generator
SVT
Supraventricular Tachycardia
Time to Therapy 
Time to therapy is defined as the interval starting 2000ms after the 
last induction artifact (the time of the post induction refractory) and 
ending at the onset of the shock deflection on the ECG recording.  
S-ICD System 
The Cameron Health/BSC subcutaneous defibrillator, including the 
SQ-RX Pulse Generator, the Q-TRAK Subcutaneous Electrode, the 
Q-TECH Programmer, and the Q-GUIDE Electrode Insertion Tool 
(EIT)
TV-ICD
Transvenous ICD
US
United States 
VF
Ventricular Fibrillation
VT
Ventricular Tachycardia 
VT/VF Storm
3 or more treated VT/VF episodes occurring within 24 hours
 

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Appendix B 
Definition of Time to Therapy 
Investigational centers are not required to measure time to therapy.  Time to therapy will be 
calculated by the sponsor or a third party designated by the sponsor.   
 
 
 
Time to Therapy 
 
 
Time to therapy is defined as the interval starting 2000ms after the last induction artifact (the 
time of the post induction refractory) and ending at the onset of the shock deflection on the 
ECG recording.  Refer to diagram above. 
 
 
 
 
Redetection Time to Therapy 
 
 
 
After the first shock has been delivered during the automatic shock sequence, the redetection 
time to therapy is defined as the interval starting 2000ms after the first shock artifact (the 
time of the post shock refractory) and ending at the onset of the subsequent shock deflection 
on the ECG recording.  Refer to diagram above. 

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Appendix C 
Source Document Annotation Guidelines 
Source Document 
Annotation 
Subject Informed Consent Form 
- 
“S-ICD PAS Consent” Form if subject to be enrolled in 
the study 
- 
“Screening ECG” Consent if subject not to be enrolled in 
the study
N/A 
 
Pre-operative screening ECG 
 Subject ID (passed ECG) or 
Screened Pt # (failed ECG) 
 ECG Lead (e.g., I, II, or III) 
 Position (e.g., supine, standing) 
 Pass or fail (each ECG)
Demographics, physical and medical history 
N/A 
Cardiovascular medication worksheet 
N/A 
Peri-operative medication worksheet  
N/A 
 
Implanted product and accessories utilized for S-ICD System 
(model/serial/lot/batch/etc.): medical notes or worksheet or 
labeling 
N/A 
Medical notes/worksheets documenting use of medical imaging 
(e.g., fluoroscopy) 
N/A 
VT/VF inductions (external ECG strips) 
 
 
 Subject ID 
 Date 
 Page numbers (if >1 page) 
 Induction Test Shock # 
 Shock source (S-ICD or External) 
 Shock Energy (J) 
 Conversion (Y/N)
Device Reports 
- 
Summary Reports 
 Redact subject name or replace 
with Subject ID 
 Study Visit
Device Reports 
- 
Captured ECG Report 
 Redact subject name or replace 
with Subject ID 
 Study Visit 
 Posture
Device Reports 
- 
Episodes (treated and untreated) 
 Redact subject name and replace 
with Subject ID 
 Study Visit 
 Rhythm  / rate
Chest X-ray(s): an X-ray is not required per protocol; upload only 
if a Chest X-Ray of the S-ICD System  was taken to assess the 
position of the S-ICD System, an S-ICD System-related adverse 
event, or product issue 
 Subject ID. 
 Redact all identifying information 
 Date of X-ray 
SD Card 
N/A 
Identifying information must be redacted from source documentation that is uploaded in the 
electronic case report form.  Failure to annotate Device Reports uploaded from SD cards will 
not result in a deviation.

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Appendix D 
Study Cohort Definitions 
 

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Appendix E 
Screening ECG 
 

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Appendix F 
Screening ECG 

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Appendix G 
Screening ECG 

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90976624 Ver. AB 
Page 73 of 76 
Appendix H 
Screening ECG 

Study Reference Number C1850  
 
 
 
 
 
 
Confidential 
Boston Scientific CRM 
S-ICD PAS Protocol 
90976624 Ver. AB 
Page 74 of 76 
Appendix I 
Screening ECG 

Study Reference Number C1850  
 
 
 
 
 
 
Confidential 
Boston Scientific CRM 
S-ICD PAS Protocol 
90976624 Ver. AB 
Page 75 of 76 
Appendix J 
Screening ECG 

Study Reference Number C1850  
 
 
 
 
 
 
Confidential 
Boston Scientific CRM 
S-ICD PAS Protocol 
90976624 Ver. AB 
Page 76 of 76 
Appendix K 
Screening ECG