A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
Phase: NA
Conditions: Chronic Pain
Sponsor: Abbott Medical Devices

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Study Name: SCS MRI PMCF 
Clinical Investigation Plan  
 
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Reference:  
SJM-CIP-10056: Ver. D [25 JUL 2019] 
 
SCS MRI PMCF 
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional 
SCS Systems 
Clinical Investigation Plan (CIP) 
 
Sponsor  
 
 
 
SJM International, Inc. (now Abbott) 
 
 
 
 
 
The Corporate Village 
 
 
 
 
 
Da Vincilaan 11- box F1 
 
 
 
 
 
1935 Zaventem  
Belgium 
Tel: +32 2 774 68 11 
Fax: +32 2 774 69 46 
 
 
 
 

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Clinical Investigation Plan  
 
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PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
CIP: SCS MRI PMCF 
 
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS 
Systems 
Version D [25 JUL 2019] 
Reference #: SJM-CIP-10056  
 
I have read and agree to adhere to the clinical investigational plan and all regulatory 
requirements applicable in conducting this clinical study. 
 
 
Principal Investigator 
 
Printed name: 
____________________________________ 
Signature: _______________________________________ 
Date: ____________________ 
 
 
 
 
 
 
 
 
 
 

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without the express written consent of Abbott 
 
Table of Contents 
 
Synopsis ........................................................................................................................................... 6 
 Study flow chart ............................................................................................................................... 8 
 Study contacts .................................................................................................................................. 9 
 
Background and Justification for Clinical Study ........................................................................... 10 
 
Risks and Benefits of the Clinical Study ........................................................................................ 10 
 Description of subject population .................................................................................................. 10 
 Anticipated clinical benefits .......................................................................................................... 11 
 Potential Adverse Effects ............................................................................................................... 11 
 Residual risks associated with the study device, as identified in the risk analysis report. ............. 11 
 Risks associated with participation in the clinical study ................................................................ 11 
 Risk-to-benefit rationale ................................................................................................................ 11 
 
Study Design .................................................................................................................................. 12 
 Purpose ........................................................................................................................................... 12 
 Study design and scope .................................................................................................................. 12 
 Number of subjects required to be included in the study ............................................................... 12 
 Estimated time needed to enroll this subject population ................................................................ 12 
 Objectives ...................................................................................................................................... 12 
4.5.1 
Primary objective .................................................................................................................... 12 
4.5.2 
Secondary objective ................................................................................................................ 12 
 Endpoints ....................................................................................................................................... 12 
4.6.1 
Primary endpoint ..................................................................................................................... 12 
4.6.2 
Secondary endpoint ................................................................................................................. 13 
 Inclusion and Exclusion Criteria .................................................................................................... 13 
4.7.1 
Inclusion criteria ..................................................................................................................... 13 
4.7.2 
Exclusion criteria .................................................................................................................... 13 
 Subject Population ......................................................................................................................... 13 
4.8.1 
Subject screening .................................................................................................................... 14 
4.8.2 
Point of enrollment.................................................................................................................. 14 
4.8.3 
Vulnerable population ............................................................................................................. 14 
 Informed Consent Process ............................................................................................................. 14 
4.9.1 
General process ....................................................................................................................... 14 
 
Study Device .................................................................................................................................. 15 
 Name of study devices ................................................................................................................... 15 
 Indication for Use .......................................................................................................................... 16 
 Description of the study devices .................................................................................................... 16 
 MRI Procedure Information Manual.............................................................................................. 17 
 Device handling & storage ............................................................................................................. 17 
 
Procedures ...................................................................................................................................... 18 
 Study flow chart ............................................................................................................................. 18 
 Procedures ...................................................................................................................................... 18 
 Enrollment visit .............................................................................................................................. 20 
 Baseline visit .................................................................................................................................. 21 
 MRI scan ........................................................................................................................................ 21 
6.5.1 
Pre-scan ................................................................................................................................... 21 

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6.5.2 
Post-scan ................................................................................................................................. 21 
 1-Month follow-up visit ................................................................................................................. 21 
 Unscheduled visit ........................................................................................................................... 21 
 Additional surgery ......................................................................................................................... 22 
 Health care economic data ............................................................................................................. 22 
 Description of activities performed by Sponsor Representatives .................................................. 22 
 Subject study completion ............................................................................................................... 22 
 Any known or foreseeable factors that may compromise the outcome ......................................... 22 
 Description of the methods that will be used to address potentially confounding factors ............. 23 
 Criteria and procedures for subject withdrawal or discontinuation ............................................... 23 
 
Compliance to CIP ......................................................................................................................... 24 
 Statements of compliance .............................................................................................................. 24 
 Adherence to the Clinical Investigation Plan ................................................................................. 24 
 Repeated and serious non-compliance ........................................................................................... 25 
 
Adverse Event, Adverse Device Effect .......................................................................................... 26 
 Definitions ..................................................................................................................................... 26 
8.1.1 
Medical device ........................................................................................................................ 26 
8.1.2 
Adverse Event (AE) ................................................................................................................ 26 
8.1.3 
Serious Adverse Event (SAE) ................................................................................................. 26 
8.1.4 
Adverse Device Effect (ADE) ................................................................................................ 26 
8.1.5 
Serious Adverse Device Effect (SADE) ................................................................................. 27 
8.1.6 
Device relationship ................................................................................................................. 27 
 Procedure for assessing, recording and reporting AEs, ADEs, SADEs:........................................ 27 
8.2.1 
Procedure for recording and reporting subject death .............................................................. 29 
 Device Deficiency (DD) ................................................................................................................ 29 
 
Data Management .......................................................................................................................... 30 
 Protection of personally identifiable information .......................................................................... 30 
 Data management plan ................................................................................................................... 31 
 Document and data control ............................................................................................................ 31 
9.3.1 
Traceability of documents and data ........................................................................................ 31 
9.3.2 
Recording data ........................................................................................................................ 31 
 Monitoring ..................................................................................................................................... 31 
 Regulatory Inspections ................................................................................................................... 31 
 Statistical Considerations ............................................................................................................... 32 
 Statistical design, hypotheses, method and analytical procedures ................................................. 32 
 Sample size .................................................................................................................................... 32 
 Pass/fail criteria to be applied to the results of the clinical study .................................................. 33 
 The provision for an interim analysis ............................................................................................ 33 
 Criteria for the termination of the clinical study on statistical grounds ......................................... 33 
 Procedures for reporting any deviation(s) from the original statistical plan .................................. 33 
 The specification of subgroups for analysis ................................................................................... 33 
 Procedures that take into account all the data ................................................................................ 33 
 The treatment of missing, unused or spurious data, including drop-outs and withdrawals ........... 33 
 
The exclusion of particular information for the testing of the hypothesis .............................. 33 
 
The minimum and maximum number of subjects to be included for each center .................. 33 

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 Document Retention ....................................................................................................................... 33 
 Amendments to Clinical Investigational Plan ................................................................................ 34 
 Investigation Suspension or Termination ....................................................................................... 34 
 Premature termination of the clinical study ................................................................................... 34 
15.1.1 Study conclusion ..................................................................................................................... 36 
 Publication Policy .......................................................................................................................... 36 
 Bibliography ................................................................................................................................... 36 
Appendix A: Abbreviations ..................................................................................................................... 38 
Appendix B: CIP Revision History .......................................................................................................... 39 
Appendix C: Declaration of Helsinki ....................................................................................................... 44 
Appendix D: Questionnaires .................................................................................................................... 45 
Appendix E: Device Manual .................................................................................................................... 46 
Appendix F: List of Clinical Investigation Sites and IRB/EC ................................................................. 47 
Appendix G: Sample Informed Consent .................................................................................................. 48 
Appendix H: Case Report Forms ............................................................................................................. 49 
 
 
 

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 SYNOPSIS  
 
Title: 
A Post-Market Study Evaluating the Prodigy MRI™ and Proclaim Elite™ 
MR Conditional SCS Systems 
Short Title: 
SCS MRI PMCF 
Purpose: 
The purpose of this study is to confirm the safety of the Prodigy MRI and 
Proclaim Elite MR conditional SCS systems.  
Objectives: 
The primary objective of this study is to confirm the safety of the Prodigy 
MRI and Proclaim Elite MR conditional SCS systems. 
 
The secondary objective of this study is to confirm that the MRI scan does 
not affect the functionality of the Prodigy MRI or Proclaim Elite MR 
conditional SCS system. 
Endpoints: 
The primary endpoint is the rate of MRI scan-related adverse events. 
 
The secondary endpoints are defined as: 
• 
Rate of successful MRI mode ‘turn on/off’ functionality  
• 
Rate of successful ‘turn on/off’ functionality for the stimulation  
• 
Rate of successful adjustments to the program 
• 
Rate of successful interrogations and uploads of the IPG parameters  
 
Design: 
The study will be performed as an international, multicenter, prospective, 
and single-arm design. The study will be conducted as a Post Market 
Clinical Follow Up (PMCF) study and the results will be submitted to the 
Notified Body: BSI Group (BSI). 
 
Enrollment: Subjects who have been implanted with a Prodigy MRI or 
Proclaim Elite SCS system and are either clinically indicated to receive an 
MRI scan, or will receive an MRI scan solely for the purposes of this 
study, will be approached to participate in this study prior to their MRI 
scan. If the subject matches all of the study eligibility criteria, they will be 
informed about the study to see if they are interested in participating. After 
the subject signs the informed consent, the enrollment is complete. 
 
Baseline: A baseline evaluation will be performed prior to the MRI scan. 
 
MRI scan: Once subject’s eligibility for an MRI scan has been confirmed, 
the MRI scan will be performed according to the SJM IFU for the 
implanted MR conditional SCS system. 
 
Immediate follow-up post-scan: An immediate post-MRI scan follow-up 
assessment will be performed to determine safety and device functionality.  
 
1-month follow-up: Subject will return to the clinic 1 month after the MRI 
scan for a safety check and device functionality check. 

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The study is complete when data from 46 unique subjects who have 
undergone an MR scan has been collected. 
Devices used: 
Prodigy MRI or Proclaim Elite MR conditional SCS systems may be used 
in this study. See section 5.0 for specific models. 
Study Population 
The subject population enrolled in this study will be comprised of male and 
female subjects. Subjects must meet the specific eligibility criteria to 
participate in the study. 
 
Approximately 49 subjects will be enrolled to collect data from 46 
subjects. Each subject will be scanned only one time for the purposes of 
this study. 
Inclusion/Exclusion 
Criteria  
Inclusion Criteria 
• 
Patient has been implanted with a Prodigy MRI or Proclaim Elite MR 
conditional SCS system 
• 
Patient will receive an MRI scan in compliance with the IFU for the 
implanted MR conditional SCS system  
• 
Patient is ≥ 18 years of age 
• 
Patient must be willing and able to comply with study requirements 
• 
Patient must indicate his/her understanding of the study and willingness 
to participate by signing an appropriate Informed Consent Form 
 
Exclusion Criteria 
• 
Patient has another implanted device (active or passive) that prohibits 
safe scanning 
• 
Patient has previously experienced an MRI scan-related adverse event 
• 
Patient is currently enrolled in another Abbott study that collects MRI 
safety data 
• 
Patient is incapacitated, is unable to read or write, or is pregnant or 
breastfeeding 
 
Data Collection 
Data will be collected at Enrollment, Baseline, pre-MRI scan, MRI scan, 
post-MRI scan, and 1-Month follow-up. 
• 
Inclusion/Exclusion Criteria 
• 
Demographics 
• 
Medical Condition indicated for an MRI scan 
• 
Implanted SCS system information 
• 
Subject eligibility for MRI scan 
• 
MRI scan parameters 
• 
Device functionality 
• 
Safety events 
 

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Study flow chart 
 
 
 
 
Enrollment
• Eligibility check
• Signing informed consent
Baseline
• Baseline data collection
MRI scan
• Pre-scan, scan and post-
scan data collection
1-month Follow-Up
• Patient visit for safety check and device 
functionality

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Study contacts 
  
SPONSOR 
 
Abbott 
The Corporate Village 
Da Vincilaan 11- box F1 
1935 Zaventem 
Belgium 
Tel: +32 2 774 68 11 
Fax: +32 2 774 69 46 
 
 
 

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express written consent of Abbott 
 
  BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
Spinal cord stimulation (SCS) involves the application of electrical stimulation to the large 
myelinated fibers of the dorsal column via electrical leads placed in the epidural space. SCS is 
minimally invasive, reversible1 and has been used successfully to help manage a variety of pain 
conditions including diabetic neuropathy,2 failed back surgery syndrome,3-6 complex regional pain 
syndrome,7,8 phantom limb pain,9 ischemic limb pain,10 as well as postherpetic neuralgia and acute 
herpes zoster pain.11  
A systematic review and meta-analysis of SCS in refractory neuropathic back and leg pain 
documented that SCS reduces pain, improves quality of life, reduces analgesic use, allows some 
patients to return to work, and may also result in significant cost savings over time with minimal 
significant adverse events.12 Because chronic pain patients continue to live normal lives using SCS, 
they may develop unrelated medical conditions that require medical imaging, such as an MRI, as part 
of their standard care. An examination of the Truven Health MarketScan Research Database estimates 
that 82% - 84% of patients eligible for SCS will require an MRI at some point within 5 years of 
implant.13 
MRI is a diagnostic method for viewing high quality two and three-dimensional images of the body. 
MRI systems generate three electromagnetic fields (i.e. a static magnetic field, a time-varying 
gradient magnetic field, and a radiofrequency field) that are used to produce the image. All three of 
these fields interact with implanted devices, creating hazards for the device, the subject, or both. Due 
to these risks, currently marketed implantable generators (IPGs), leads, or accessories may be 
contraindicated for use in an MRI environment.  
Abbott (formerly St. Jude Medical) has developed MR conditional neurostimulation systems designed 
to mitigate such interactions. These systems provide the option for conditionally safe scanning of 
subjects when the scan is performed according to approved guidelines. MRI compatible devices 
improve patient care by reducing limitations that would otherwise prevent patients from taking 
advantage of this commonly used diagnostic tool.  
The devices used in this study have received CE mark and are being implanted in subjects. CE mark 
was granted based on preclinical device testing. This study will be conducted as a post-market clinical 
follow up (PMCF) study to collect additional scientific data to support the CE label for Prodigy 
MRI™ and Proclaim Elite™ systems. Patients with an existing Prodigy MRI or Proclaim Elite MR 
conditional system who either undergo an MRI scan as standard of care, or agree to an MRI scan for 
study purposes, will be interviewed before the scan, after the scan, and 30 days later to determine 
device functioning and record any related adverse events. The rate of MRI scan-related adverse events 
will be used to evaluate the safety of these MR conditional SCS systems when used in compliance 
with the approved requirements. 
  RISKS AND BENEFITS OF THE CLINICAL STUDY 
 
Description of subject population 
The subject population enrolled in this study will be comprised of male and female subjects who 
have a previously implanted Prodigy MRI or Proclaim Elite MR conditional SCS system. Subjects 
must meet the specific eligibility criteria and provide informed consent to participate in the study.  

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Anticipated clinical benefits 
The primary benefit of the MR conditional SCS systems is that they provide subjects with the option 
to receive a MRI scan when clinically necessary, while defining the conditions for use that 
maximize subject safety.  
If subjects agree to take part in this study, there may or may not be direct medical benefits to 
individual subjects. The scientific use of the data collected in this study is to support the CE label 
of the Prodigy MRI and Proclaim Elite MR conditional SCS systems by confirming they are 
conditionally safe for MRI scans. 
 
Potential Adverse Effects 
The Prodigy MRI and Proclaim Elite MR conditional SCS systems have been designed to minimize 
the potential adverse effects that may cause subject harm. The following potential adverse effects 
may occur in the MRI environment: 
• 
Lead electrode heating resulting in tissue damage or serious subject injury 
• 
IPG heating resulting in tissue damage in the implant pocket or subject discomfort or both 
• 
Induced currents on leads resulting in overstimulation or shocking sensations 
• 
Damage to the IPG or leads causing the system to fail to deliver stimulation or causing the 
system to deliver overstimulation 
• 
Damage to the functionality or mechanical integrity of the IPG resulting in the inability to 
communicate with the IPG 
• 
Movement or vibration of the IPG or leads 
 
Residual risks associated with the study device, as identified in the risk analysis report. 
The clinical risks associated with neurostimulation systems for SCS applications are well known. 
Many of the clinical risks may develop as a consequence of not following the manufacturer 
recommended guidelines at the time of performing the MRI scans. 
Any potential residual risks are considered to be outweighed by the benefits, and the overall residual 
risk was determined to be acceptable. Clinical evidence demonstrates acceptable safety and 
performance of the study device.  
 
Risks associated with participation in the clinical study 
The risks involved with this study are comparable to those associated with the implant of any other 
commercially available MR conditional SCS system. 
 
Risk-to-benefit rationale 
Since no design changes exist between the Prodigy MRI and Proclaim Elite MR conditional SCS 
systems and the predicate SCS systems, except for implementation of the MRI Mode, the non-MR 
performance of these products is already well established.  
 
In addition, the clinical evidence demonstrates that the safety and performance of the study device, 
when used under the conditions and for the purposes intended, as specified by the manufacturer, 
are in compliance with the Requirements of the AIMD Directive 90/385/EEC, including the 
Essential Requirements. 
 

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Subjects receiving an MRI as standard of care will receive that benefit irrespective of their 
participation in this study. The MRI scan may not provide additional benefit for subjects who 
receive a scan without an underlying medical need. 
 
Any undesirable side effects, under normal conditions of use, are considered acceptable risks when 
weighed against the performance of the device and benefits to the subject. 
   STUDY DESIGN 
 
Purpose 
The purpose of this study is to confirm the safety of the Prodigy MRI and Proclaim Elite MR 
conditional SCS systems. 
 
Study design and scope 
The study will be performed as an international, multicenter, prospective, and single-arm design. 
The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results 
will be submitted to the Notified Body: BSI Group (BSI). 
 
The study will be conducted in approximately 20 centers in Europe and up to 10 centers in the US. 
 
Number of subjects required to be included in the study 
Approximately forty-nine (49) subjects will be enrolled in the study. Data from only 1 scan per 
subject will be collected in the study. 
 
Estimated time needed to enroll this subject population 
The expected enrollment rate for patients requiring MRIs with an eligible MR conditional device 
is no more than 10 subjects per year. It is unknown how many patients will be interested in receiving 
an MRI scan for study purposes without an underlying medical need. Therefore, the number of 
enrollments per year for this group cannot be predicted with precision. However, we estimate that 
this number will not be less than the 10 subjects per year that are estimated to require an MRI for 
medical purposes. Therefore, we estimate that enrollment may continue for up to 6 years.  
 
Objectives 
4.5.1 
Primary objective 
The primary objective of this study is to confirm the safety of the Prodigy MRI and Proclaim Elite 
MR conditional SCS systems. 
4.5.2 
Secondary objective 
The secondary objective is to confirm that the MRI scan does not affect the functionality of the 
Prodigy MRI or Proclaim Elite MR conditional SCS system. 
 
 
 
Endpoints 
4.6.1 
Primary endpoint 
The primary endpoint is the rate of MRI scan-related adverse events. 
 

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4.6.2 
Secondary endpoint 
The secondary endpoints are defined as: 
• 
Rate of successful MRI mode ‘turn on/off’ functionality  
• 
Rate of successful ‘turn on/off’ functionality for the stimulation  
• 
Rate of successful adjustments to the program 
• 
Rate of successful interrogations and uploads of the IPG parameters 
 
Inclusion and Exclusion Criteria 
A subject, who meets all inclusion criteria and none of the exclusion criteria, is eligible to 
participate in this study.  
 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost 
to follow-up) will be accounted for and documented, assigning an identification code linked to their 
names, alternative identification, or contact information. 
 
This log will be kept up to date throughout the clinical study by the Principal Investigator or his/her 
authorized designee. To ensure subject privacy and confidentiality of data, this log must be 
maintained throughout the clinical study at the clinical site. 
4.7.1 
Inclusion criteria 
To participate in this clinical study, the subject must meet all the following inclusion criteria: 
• 
Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system 
• 
Patient will receive an MRI scan in compliance with the IFU for the implanted MR conditional 
SCS system 
• 
Patient is ≥ 18 years of age 
• 
Patient must be willing and able to comply with study requirements 
• 
Patient must indicate his/her understanding of the study and willingness to participate by 
signing an appropriate Informed Consent Form 
4.7.2 
Exclusion criteria 
Subjects are not eligible for clinical study participation if they meet any of the following exclusion 
criteria: 
• 
Patient has another implanted device (active or passive) that prohibits safe scanning 
• 
Patient has previously experienced an MRI scan-related adverse event 
• 
Patient is currently enrolled in another Abbott study that collects MRI safety data 
• 
Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding 
 
Subject Population 
The subject population enrolled in this study will be comprised of male and female subjects from 
the chronic pain population who have a previously implanted Prodigy MRI or Proclaim Elite MR 
conditional SCS system. 
 
Subjects will either receive an MRI scan as part of standard of care or will receive an MRI scan 
without an underlying medical necessity solely for the purposes of this study.  
 

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Subjects must meet the specific eligibility criteria and provide informed consent to participate in 
the study. 
4.8.1 
Subject screening 
All subjects presenting at the investigational site can be screened by a member of the 
investigational team previously trained on the CIP and delegated to do so.  
 
Subjects who do not meet the inclusion/exclusion criteria will not be eligible to participate in this 
study. Subjects meeting the inclusion criteria and none of the exclusion criteria will be fully 
informed about the study and asked to participate in the study.  
 
In case the subject agrees, a duly signed and dated Informed Consent form will be obtained. Once 
enrolled, the subject is expected to comply with the scheduled visits and required activities 
according to the protocol. 
4.8.2 
Point of enrollment 
A subject is enrolled in this study only when he/she has provided a written signed and dated 
Informed Consent form. 
4.8.3 
Vulnerable population 
Not applicable. 
 
Informed Consent Process 
4.9.1 
General process 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s IRB/EC. This process will include a 
verbal discussion with the subject on all aspects of the clinical investigation that are relevant to the 
subject’s decision to participate, such as details of clinical investigation procedures, anticipated 
benefits, and potential risks of clinical investigation participation. Subjects must be informed about 
their right to withdraw from the clinical investigation at any time and for any reason without sanction, 
penalty or loss of benefits to which the subject is otherwise entitled. Withdrawal from the clinical 
investigation will not jeopardize their future medical care or relationship with the investigator.  
During the discussion, the Principal Investigator or his/her authorized designee will avoid any 
improper influence on the subject and will respect subject’s legal rights. Financial incentives will not 
be given to the subject. Subjects may be compensated for time and travel directly related to the 
participation in the clinical investigation. The subject shall be provided with the Informed Consent 
form written in a language that is understandable to the subject and has been approved by the center’s 
IRB/EC. The subject shall have adequate time to review, ask questions, and consider participation. 
The Principal Investigator or his/her authorized designee will make efforts to ensure that the subject 
understands the information provided. If the subject agrees to participate, the Informed Consent form 
must be signed and dated by the subject and thereafter by the person obtaining the consent prior to 
any clinical investigation-specific procedures. The signed original will be filed in the subject’s 
hospital or research charts, and a copy will be provided to the subject. 
 

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Failure to obtain informed consent from a subject prior to clinical investigation enrollment should be 
reported to Sponsor within 5 working days and to the reviewing center’s IRB/EC according to the 
IRB’s/ EC’s reporting requirements. 
If, during the clinical investigation, new information becomes available that can significantly affect 
a subject's future health and medical care, the Principal Investigator or his/her authorized designee (if 
applicable) will provide this information to the subject. If relevant, the subject will be asked to 
confirm their continuing informed consent in writing. 
4.9.1.1 Special Circumstances for Informed Consent 
Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or 
individuals without legal authority are excluded from the study population. Individuals under 
the age of 18 or age of legal consent are excluded from the study population. Individuals unable 
to read or write are excluded from the study population. Pregnant or breastfeeding women are 
excluded from the study population. 
In addition, an authorization for use and disclosure of the subject’s protected health 
information, in accordance with the Health Insurance Portability and Accountability Act 
(HIPAA), must be obtained from the subject or their legally acceptable representative.  
 STUDY DEVICE  
 
Name of study devices 
Any market-released, Prodigy MRI or Proclaim Elite MR conditional SCS system may be used in 
this study along with its relevant accessories. Table 1 includes a list of all devices included in this 
study.  
 
Table 1. Study Devices 
Device name 
Model/Type 
Serial/Lot 
Controlled 
Manufacturer 
Region/ 
Country 
Investigational or 
Market Released 
Proclaim Elite 
Implantable 
Pulse Generator 
3660 & 3662 
Serialized 
St. Jude Medical 
Global 
Market Released 
Prodigy MRI 
Implantable 
Pulse Generator 
3772 
Serialized 
St. Jude Medical 
Global 
Market Released 
Octrode™ Lead 
3186 
Serialized/Lot St. Jude Medical 
Global 
Market Released 
Penta™ Lead  
3228 
Serialized/Lot St. Jude Medical 
Global 
Market Released 
Butterfly Anchor 1105 
Lot 
St. Jude Medical 
Global 
Market Released 

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Device name 
Model/Type 
Serial/Lot 
Controlled 
Manufacturer 
Region/ 
Country 
Investigational or 
Market Released 
Long Anchor 
1106 
Lot 
St. Jude Medical 
Global 
Market Released 
Swift-Lock™ 
Anchor 
1192 
Lot 
St. Jude Medical 
Global 
Market Released 
Cinch™ Anchor 
1194 
Lot 
St. Jude Medical 
Global 
Market Released 
Prodigy 
Charging System 3730 
Serialized 
St. Jude Medical 
Global 
Market Released 
Prodigy Patient 
Programmer 
3856 
Serialized 
St. Jude Medical 
Global 
Market Released 
Rapid 
Programmer™ 
System 
3835 
Serialized 
St. Jude Medical 
Global 
Market Released 
Clinician 
Programmer 
3872 
Serialized 
St. Jude Medical 
Global 
Market Released 
Patient 
Controller 
3883 
Serialized 
St. Jude Medical 
Global 
Market Released 
Note: Changes to the lead manufacturing process means that some existing leads may have been lot controlled while 
others were serialized. 
 
Indication for Use 
The Prodigy MRI and Proclaim Elite SCS systems are indicated as an aid in the management of 
chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated 
with the following: failed back surgery syndrome and intractable low back and leg pain. 
 
Description of the study devices 
Please refer to the country- and device-specific IFU for additional information regarding the devices 
used in this clinical investigation. 
The Proclaim Elite system is MR conditional for scans of the head, extremities (upper except 
shoulder, lower except hip), or any other body part. The Prodigy MRI system is only MR 
conditional for scans of the head and extremities (upper except shoulder, lower except hip). Scan 
requirements for each system (Proclaim Elite and Prodigy MRI)/lead (Octrode and Penta) 
combination are provided in the MRI Procedure Information Manual. 
Clinically relevant MRI safety criteria identified by St. Jude Medical (now Abbott) are unchanged 
between the Prodigy MRI and Proclaim Elite systems. Additional Proof of Safety testing has 
demonstrated that the Proclaim Elite device satisfies these same criteria when used with a body RF 

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transmit coil under the specified scan conditions. Therefore, data gathered on Proclaim Elite and 
Prodigy MRI will be evaluated as a single group. 
 
MRI Procedure Information Manual 
To ensure the MR Conditional requirements are met, the healthcare providers involved in MRI 
scanning of the Prodigy MRI and Proclaim SCS systems will need to take multiple actions. To 
ensure subject and device safety during the MRI procedure, a recommended procedural workflow 
has been developed in the MRI Procedure Information manual. To collect impedance check data in 
this study, this clinical investigation plan adds the requirement of having a Clinician Programmer 
(for Proclaim devices) or a Rapid Programmer (for Prodigy devices) present at every MRI scan. 
 
The MRI Procedure Information manual allows for the determination of whether conditions have 
been satisfied by the SCS system and the MR environment to qualify for an MRI scan. This labeling 
allows radiologists and MR technologists to identify MR conditional components and assess 
whether their MRI equipment can safely scan a subject implanted with an Abbott (formerly St. Jude 
Medical) MR conditional SCS system. Guidance is also provided to the physician and subject on 
how to prepare for an MRI scan. 
 
Additionally, a Subject Identification (ID) Card is provided to all subjects as labeling that allows 
for identification of their implanted neurostimulation system in support of determining if the subject 
has an MR conditional system.  
 
Additional resources (including the MRI Procedure Information manual) for ensuring that the MRI 
scan complies with the MRI conditional labeling can be obtained from the Sponsor or found on the 
following websites: 
• 
https://www.sjm.com/en/professionals/resources-and-reimbursement/technical-
resources/mri-ready-resources 
• 
https://manuals.sjm.com/ 
 
Device handling & storage 
The Sponsor requires all products to be stored according to the appropriate labeling and IFU as per 
standard practice at each center. 

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 PROCEDURES 
 
Study flow chart 
 
 
Procedures 
The clinical study will be conducted in accordance with the CIP. All parties participating in the 
conduct of the clinical study will be qualified by education, training, or experience to perform their 
tasks and this training will be documented appropriately. 
 
The clinical study will not commence until Abbott receives written approval from the IRB/EC and 
relevant regulatory authorities and all required documents have been collected from the site(s). 
 
Table 2: List of all study specific activities/procedures 
Visit 
 
 
 
 
 
 
 
 
 
 
Study Activity 
Enrollment  
(in clinic, prior to MRI scan) 
Baseline 
(in clinic,  
prior to MRI scan)  
MRI scan 
(in clinic, pre-, during, and 
post-scan  
  
1 Month follow up 
(in clinic,  
1 months ± 10 days since MRI 
scan)  
Unscheduled 
Additional surgery 
Informed Consent Process 
X 
 
 
 
 
 
Enrollment
• Eligibility check
• Signing informed consent
Baseline
• Baseline data collection
MRI scan
• Pre-scan, scan and post-scan data collection 
1-month follow-up (±10 days)
• Patient visit for safety check and device 
functionality check

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Visit 
 
 
 
 
 
 
 
 
 
 
Study Activity 
Enrollment  
(in clinic, prior to MRI scan) 
Baseline 
(in clinic,  
prior to MRI scan)  
MRI scan 
(in clinic, pre-, during, and 
post-scan  
  
1 Month follow up 
(in clinic,  
1 months ± 10 days since MRI 
scan)  
Unscheduled 
Additional surgery 
Inclusion/Exclusion 
Criteria Check 
X 
 
 
 
 
 
Demographics Collection 
 
X 
 
 
 
 
Collection of Medical 
Condition indicated for 
MRI scan  
 
X 
 
 
 
 
Subject eligibility for MRI 
scan Check 
 
 
X (pre-
scan) 
 
 
 
Lead and IPG data 
Collection 
 
X 
 
 
 
X 
Programming 
Functionality 
 
 
X (pre- and 
post-scan) 
X 
X 
 
Device Functionality 
Check 
 
 
X (pre-and 
post-scan) 
 
 
 
MRI Scan 
 
 
X 
 
 
 
MRI Scan Parameters 
Collection 
 
 
X 
 
 
 
Determine Reason for the 
Visit and Action Taken 
 
 
 
 
X 
X 
Adverse Events Check 
 
(X) 
(X) 
(X) 
(X) 
(X) 
Protocol Deviation 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
  
(X) if applicable 
 
Informed Consent Procedure and Inclusion/Exclusion Criteria:  
Subject’s eligibility criteria and Informed Consent Procedure is performed at the Enrollment visit.  
 
Demographics:  
Subject’s year of birth, weight, height, and sex will be collected at the Baseline visit.  
 
Medical Condition indicated for MRI Scan: 
Subject’s medical condition requiring a MRI scan will be collected at the Baseline visit.  
 
Subject’s eligibility for MRI scan: 
Subject’s eligibility for MRI scan will be checked BEFORE the scan will be done. 
 
Lead, Extension, Anchor and IPG Data:  
At Baseline, and in case of additional surgery, information of the implanted leads and IPG (model 
number, serial/lot number, and positions), presence and type of any anchors used, as well as the 
presence of lead extensions, will be collected.  
 
Programming Functionality:  

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Information regarding the ability to re-program will be collected at pre- and post-scan, during the 
1-month follow up visit and at unscheduled visits. 
 
Device Functionality:  
Data regarding the device functionality, including impedance check, will be collected pre-and post-
scan.  
 
MRI Scan: 
MRI scan will be conducted in compliance with the SJM Instructions for Use (IFU) for the 
implanted MR conditional SCS system and the MRI Procedure Information manual. 
 
MRI Scan Parameters: 
MRI scan parameters will be documented post-scan. 
 
Reason for the Visit and Action taken: 
Information regarding the reason for the visit, as well the action taken, will be collected in case of 
unscheduled visit or additional surgery. 
 
Adverse Events Check: Serious adverse events (SAEs) and/or MRI scan-related adverse events 
will be checked at all visits except enrollment.  
 
Enrollment visit  
(In clinic, prior to performing MRI scan) 
 
The following activities are performed after the subject has been screened and must occur before 
any procedure/visit. 
• 
The principal or delegated Investigator is responsible for screening all potential subjects to 
determine subject eligibility for the study 
• 
If a subject meets all inclusion criteria and does not meet any of the exclusion criteria, he/she is 
eligible for the study 
• 
The subject is enrolled in the study when the subject signed the EC approved consent form 
Enrollment information (name of the study, date of consent and inclusion/exclusion information) 
will be recorded in the hospital records the Enrollment form will be completed, preferably within 5 
days after enrollment.  
  
As soon as the subject signs the Informed Consent Form, AEs need to be reported according to the 
guidelines mentioned in this CIP.  
 
In case the subject was consented to participate in the study, but does not meet inclusion/exclusion 
criteria, and did not receive a MRI scan, the subject should be withdrawn and a Withdrawal form 
must be completed. The subject will resume his/her regular standard of care with his/her physician. 
 
In case the subject was consented to participate in the study and did receive a MRI scan, but does 
not meet inclusion/exclusion criteria, it will be considered a protocol violation. A protocol deviation 
form needs to be completed and the Sponsor must be informed. The EC and Competent Authority 

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(CA), if applicable, should be notified appropriately about any deviations with regards to the 
violation of inclusion/exclusion criteria.  
 
Baseline visit  
(In clinic, prior to performing MRI scan)  
The baseline visit may be conducted on the same day as -but prior to- the MRI scan.  
 
The following information will be collected at the baseline visit: 
• 
Demographics  
• 
Medical condition indicated for an MRI scan 
• 
Lead and IPG data 
• 
AE and/or protocol deviation (if applicable) 
 
MRI scan 
(In clinic) 
There is no minimum required time gap between implantation of the neurostimulator and the MRI 
scan. This will be determined by the physician’s standard of care. 
6.5.1 
Pre-scan 
• 
Subject eligibility for MRI scan 
• 
Device functionality, including impedance check 
• 
Programming functionality 
• 
AE and/or protocol deviation (if applicable) 
 
MRI scan will be performed. Ensure to follow the instructions as mentioned in the MRI Procedure 
manual. 
6.5.2 
Post-scan 
• 
MRI scan information 
• 
DICOM image files (deidentified) if available 
• 
Device functionality 
• 
Programming functionality  
• 
AE and/or protocol deviation (if applicable) 
 
1-Month follow-up visit 
(In clinic, 1 month ± 10 days since MRI scan) 
 
The following information will be collected at the 1-month follow-up visit: 
• 
Programming functionality 
• 
AE and/or protocol deviation (if applicable) 
 
Unscheduled visit  
Subjects may be asked or need to return to the clinic to assess various program parameters and 
stimulation coverage or undergo additional surgery. If this occurs, the following information will 
be recorded:  
• 
Reason for visit 

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• 
Action taken 
• 
Programming functionality (if applicable) 
• 
AE and/or protocol deviation (if applicable) 
• 
Additional surgery information (if applicable) 
 
Additional surgery 
Subjects may be asked to return to the clinic for an additional surgery to revise, replace, reposition, 
or explant the leads or IPG. If this occurs, the following information will be recorded:  
• 
Reason for surgery 
• 
Action performed 
• 
Lead and IPG data (if applicable) 
• 
AE and/or protocol deviation (if applicable) 
 
Health care economic data   
Not applicable. 
 Description of activities performed by Sponsor Representatives 
Trained sponsor personnel may perform certain activities to ensure compliance to the 
investigational plan and may provide technical expertise. 
Sponsor personnel may: 
• 
Provide technical support to the Investigators during MRI scan, additional surgery, and 
programming 
Sponsor personnel will not: 
• 
Perform the informed consent process 
• 
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 
a health care practitioner 
• 
Independently collect clinical investigational data 
 Subject study completion 
When the subject’s participation in the clinical study has been completed (at 1-Month Follow-Up), 
the subject will return to the medical care as per physician’s recommendation. 
 Any known or foreseeable factors that may compromise the outcome  
All foreseeable factors that may compromise the outcome of the clinical study or the 
interpretation of the results have been accounted for by clinical study design and well-defined 
subject selection criteria. 
 
Subject recruitment and retention will be mastered throughout the study and include (but are not 
limited to) the following activities: evaluation of the site and Investigators, training of site 
personnel, developing site support materials, providing subject visit calendars.  
 

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A Clinical Events Committee (CEC) will be formed as best practice to ensure that the primary 
outcome is as free from bias as possible. The CEC will review and adjudicate reportable adverse 
events as defined in the CEC charter for seriousness, device-relatedness, and MRI-relatedness. 
 Description of the methods that will be used to address potentially confounding factors 
Stratified analysis will be used to diagnose the potential confounding factors, and multiple 
regression will be used to adjust the outcome of the primary endpoint in case confounding factors 
are identified. The factors of interest can be, but are not limited to:  
• 
Subject baseline characteristics 
• 
Use of other medical devices 
 Criteria and procedures for subject withdrawal or discontinuation 
Each subject should remain in the study until completion of the required follow up period; however, 
a subject’s participation in the study may be discontinued at any time. Should this occur, the reason 
for discontinuation must be documented in the withdrawal form. 
 
Subjects must be informed about their right to withdraw from the study at any time, and for any 
reason, without sanction, penalty, or loss of benefits to which the subject is otherwise entitled and 
that withdrawal from the study will not jeopardize their future medical care or relationship with the 
Investigator. Subjects will be asked to specify the reason for the termination but have the right not 
to answer. 
 
The Investigator may decide to withdraw a subject from the study at any time with reasonable 
rationale. The subject’s future care will not be influenced by a decision, voluntary or otherwise, to 
withdraw from the study. All reasonable efforts should be made to retain the subject in the clinical 
study until completion of the study. 
 
Reasons for subject’s withdrawal include, but are not limited to: 
• 
Subject refuses to continue participating in the study 
• 
Subject does not meet the inclusion/exclusion criteria and does not require additional follow-
up for safety reasons. 
• 
Subject is deceased (cause must be documented) 
• 
Subject’s non-compliance 
• 
Subject’s participation is terminated by the PI or Investigator, although the subject consented, 
since participation is no longer medically appropriate 
• 
Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow up visits but has 
not explicitly requested to be withdrawn from the clinical study this does not apply to missed 
visits). Site personnel should make all reasonable efforts to locate and communicate with the 
subject to achieve subject compliance to the scheduled follow up visits: 
o A subject will be considered ‘Lost to Follow Up’ after a minimum of 2 phone calls of a 
physician or delegate at the investigational site to the subject or contact. These 2 phone calls 
need to be documented in the subject’s hospital records. 
o If these attempts are unsuccessful, a letter should be sent to the subject’s last known address 
or general practitioner (GP) and a copy of this letter should be maintained in the subject’s 
hospital records. 
 

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If a subject withdraws from the clinical study, the site will record the subject’s reasons for 
withdrawal on a Withdrawal CRF. 
 
No additional follow–up will be required or data recorded from subjects once withdrawn from the 
clinical investigation. 
 COMPLIANCE TO CIP 
 
Statements of compliance 
The study will be performed in accordance with the most current versions of the World Medical 
Association (WMA) Declaration of Helsinki, and any regional and/or national regulations as 
appropriate. 
 
The current version of the harmonized ISO14155 shall be used as a guideline. 
 
 
The Investigator will not start enrolling subjects or requesting informed consent from any subject 
prior to obtaining IRB/EC approval and Competent Authority approval, if applicable, and 
authorization from the sponsor in writing for the study. 
 
 
 
In case additional requirements are imposed by the IRB/EC or Competent Authority, those 
requirements will be followed, if appropriate. If any action is taken by an IRB/EC, and regulatory 
requirements with respect to the study, that information will be forwarded to Abbott. 
 
As sponsor, Abbott has taken up general liability insurance in accordance with the requirements of 
the applicable local laws. 
 
If required, additional subject coverage or a study specific insurance will be provided by the 
Sponsor as well. 
 
Adherence to the Clinical Investigation Plan 
A deviation is defined as an event where the clinical Investigator, site personnel, sponsor or sponsor 
representative did not conduct the clinical study according to the Clinical Investigational Plan, 
IRB/EC requirements, or the Investigator Agreement. The Investigator is not allowed to deviate 
from the CIP, except as specified under emergency circumstances.  
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety 
and well-being of subjects, since the non-compliance exposes subjects to unreasonable risks. For 
example, failure to adhere to the inclusion/exclusion criteria: these criteria are specifically defined 
by the Sponsor to exclude subjects for whom the device is not beneficial and use involves 
unreasonable risks. This may be considered failure to protect the rights, safety, and well-being of 
the enrolled subject. Similarly, failure to perform safety assessments intended to detect adverse 
events may be considered failure to protect the rights, safety and well-being of the enrolled subject. 
Investigators should seek minimization of such risks by adhering to the CIP. 
 
Simultaneously, in the event that adhering to the CIP might expose the subject to unreasonable 
risks, the Investigator is also required to protect the rights, safety, and well-being of the subject by 

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intentionally deviating from the requirements of the CIP so that subjects are not exposed to 
unreasonable risks.  
 
It is the responsibility of the Investigator to provide adequate medical care to a subject enrolled in 
an investigation. 
 
Regulations require that the PI maintain accurate, complete, and current records, including 
documents showing the date of, and reason for, every deviation from the Clinical Investigational 
Plan. Relevant information for each deviation will be documented on a Deviation Case Report 
Form. The site will submit the CRF to Abbott. 
 
Regulations require Investigators obtain approval from Abbott and the IRB/EC (as required) before 
initiating changes in or deviations from the protocol, except when necessary to protect the life or 
physical well-being of a subject in an emergency.  
 
Prior approval must be requested when the PI anticipates, contemplates, or makes a conscious 
decision to depart from the CIP, except when unforeseen circumstances are beyond the 
Investigator’s control (e.g. a subject who fails to attend a scheduled follow-up visit, a subject is too 
ill to perform a CIP-required test, etc.). All deviations, including those beyond the Investigator’s 
control, must be reported on a CRF. 
 
To obtain approval, the Principal Investigator may call or email and discuss the potential deviation 
with Abbott or designee prior to initiating any changes.  
 
All deviations must be reported to appropriate regulatory authorities in specified timelines (if 
appropriate). 
 
The Investigator is required to adhere to local regulatory requirements for reporting deviations to 
IRB/EC. 
 
Repeated and serious non-compliance 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by 
the Sponsor, a Clinical Research Associate or clinical representative will attempt to secure 
compliance by one or more of the following actions: 
• 
Visiting the Investigator 
• 
Contacting the Investigator by telephone 
• 
Contacting the Investigator in writing 
• 
Retraining of the Investigator 
 
If an Investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or 
any other conditions of the clinical study, the Sponsor will either secure compliance or, at its sole 
discretion, terminate the Investigator’s participation in the clinical investigation. 

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 ADVERSE EVENT, ADVERSE DEVICE EFFECT 
 
Definitions 
8.1.1 
Medical device 
Any instrument, apparatus, machine, appliance, implant, software, material, or other similar or 
related article:  
• 
Intended by the manufacturer to be used, alone or in combination, for human beings for one or 
more of the specific purpose(s) of 
o Diagnosis, prevention, monitoring, treatments or alleviation of disease 
o Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury 
o Investigation, replacement, modification, or support of the anatomy or of a physiological 
process 
o Supporting or sustaining life 
o Control of conception 
o Disinfection of medical devices 
• Which does not achieve its primary intended action in or on the human body by 
pharmacological, immunological, or metabolic means, but which may be assisted in its 
intended function by such means. 
8.1.2 
Adverse Event (AE) 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether or not related to the medical device under study. 
 
Note 1: This definition includes events related to the medical device under study. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices 
under investigation. 
8.1.3 
Serious Adverse Event (SAE) 
An adverse event that led to: 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o A life-threatening illness or injury OR 
o A permanent impairment to a body structure or a body function OR 
o An in-subject or prolonged hospitalization OR 
o A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body OR 
• 
Fetal distress, fetal death, or a congenital abnormality or birth defect 
• 
Malignant tumor 
 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is 
not considered a serious adverse event. 
8.1.4 
Adverse Device Effect (ADE) 
An adverse event related to the use of a study device. 

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This definition includes adverse events resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or operation, or any malfunction of the study device. 
 
This definition includes any event resulting from the use error or from intentional misuse of the 
study device. 
8.1.5 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event. 
8.1.5.1 Unanticipated Serious Adverse Device Effect (USADE)  
A serious adverse device effect which, by its nature, incidence, severity, or outcome has not 
been identified in the current version of the risk analysis report. 
8.1.6 
Device relationship 
Determination of whether there is a reasonable possibility that a study device caused or contributed 
to an AE will be determined by the Investigator and recorded on the appropriate CRF. 
Determination should be based on assessment of temporal relationships, evidence of alternative 
etiology, medical/biologic plausibility, and patient condition (pre-existing condition). 
 
Procedure for assessing, recording and reporting AEs, ADEs, SADEs:  
Safety surveillance within this study and the safety reporting, both performed by the Investigator, 
starts as soon as the subject is enrolled in this study (date of signature of the informed consent). The 
safety surveillance and the safety reporting will continue until the last study visit has been 
performed, the subject is deceased, the subject/Investigator concludes his participation in the study 
or the subject/Investigator withdraws the subject from the study. 
 
Records related to the subject’s subsequent medical course must be maintained and submitted (as 
applicable) to the Sponsor until the event has subsided or, in case of permanent impairment, until 
the event stabilizes and the overall clinical outcome has been ascertained. Adverse events will be 
monitored until they are adequately resolved. The status of the subject’s condition should be 
documented at each visit.  
 
Adverse event data will be collected throughout the clinical study and will be reported to the 
Sponsor on a dedicated case report form.  
 
Reportable events to sponsor are considered:  
1. All Serious Adverse Events 
2. All procedure- (e.g., MRI scan) or device-related Adverse Events (whether or not the event is 
considered serious). 
 
SAE Reporting 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than outlined 
below.  
 
Clinical Site 
Reporting timelines 

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All Sites 
SAEs must be reported to the Sponsor no later than 3 calendar days from the day 
the site personnel became aware of the event or as per the investigative site’s local 
requirements, if the requirement is more stringent than those outlined. 
 
The date the site staff became aware the event met the criteria of an SAE must be recorded in the 
source document.  The Investigator will further report the SAE to the local IRB/EC according to 
the institution’s IRB/EC reporting requirements. 
 
The Sponsor will ensure that all events are reported to the relevant authorities as per regulations.  
 
Foreseeable Adverse Effects 
In addition to the adverse events commonly associated with surgery, the following adverse effects 
are associated with implanting or using the neurostimulation for SCS. 
 
List of foreseeable adverse effects: 
• 
Unpleasant sensations or motor disturbances, including involuntary movement, caused by 
stimulation at high outputs (if either occurs, turn off the IPG immediately) 
• 
Undesirable changes in stimulation, which may be related to cellular changes in tissue around 
the electrodes, changes in electrode position, loose electrical connections, or lead failure 
• 
Stimulation in unwanted places 
• 
Lead migration, causing changes in stimulation or reduced pain relief 
• 
Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from 
placement of a lead in the epidural space  
• 
Cerebrospinal fluid (CSF) leakage 
• 
Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant 
• 
Persistent pain at the electrode or IPG site 
• 
Seroma (mass or swelling) at the IPG site 
• 
Allergic or rejection response to implant materials 
• 
Implant (IPG) migration or skin erosion around the implant 
• 
Battery failure or battery leakage 
Changes in stimulation parameters may occur due to the failure of, or changes in, components over 
time, which results in: 
• 
Understimulation 
• 
Return of underlying symptoms 
• 
Overstimulation 
• 
Premature battery depletion 
• 
The need to explant the device 
The following potential adverse effects may occur in the MRI environment: 
• 
Lead electrode heating resulting in tissue damage or serious subject injury 
• 
IPG heating resulting in tissue damage in the implant pocket, or subject discomfort, or both 
• 
Induced currents on leads resulting in overstimulation or shocking sensations 
• 
Damage to the IPG or leads causing the system to fail deliver stimulation or causing the system 
to deliver overstimulation 
• 
Damage to the functionality or mechanical integrity of the IPG resulting in the inability to 
communicate with the IPG 

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• 
Movement or vibration of the IPG or leads 
 
In addition, subjects may experience unavoidable events related to the MRI scan. An unavoidable 
event is an event related to the MRI scan that may occur for a projected duration in any subject. 
Unavoidable events are expected to occur with any MRI scan and are not reportable unless the 
condition worsens or continues beyond the timeframe listed below. Unavoidable events do not need 
to be reported on an Adverse Event form if they are resolved within the time frame specified. 
 
Table 3. List of unavoidable MRI-related events 
Event 
Timeframe 
Claustrophobia 
During MRI scan 
Mild diaphoresis 
During and < 1-hour post MRI scan 
Sensation of bodily warmth 
During and < 1-hour post MRI scan 
Sensation of warmth at device pocket 
not arising to the level of discomfort 
During and < 1-hour post MRI scan 
Hearing Impairment 
< 24 hours post MRI scan 
Body Stiffness related to immobility 
< 48 hours post MRI scan 
 
8.2.1 
Procedure for recording and reporting subject death 
All subject deaths that occur during this study must be reported to Abbott within 3 calendar days 
of the site being notified (refer to Section 8.2).  Notification of a death should include a detailed 
statement of the pertinent events and be signed by the investigator in addition to the completion 
of the appropriate forms (Death form and Withdrawal form) and submitted to Abbott using the 
paper CRFs in this study. It is the Investigator’s responsibility to notify the IRB/EC per the 
IRB/EC policy. 
 
Device Deficiency (DD)  
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use 
errors, and inadequate labeling. 
 
Device deficiencies are not collected in this study. While some device functionality information 
will be collected as secondary endpoints (Section 4.6.2), the device deficiency reporting 
instructions below should be followed for all device deficiencies identified during this study.  
 
If the device deficiency does not involve an AE, the Investigator must notify the Abbott Post Market 
Surveillance 
Department 
by 
submitting 
the 
complaint 
information 
via 
email 
to 
CCoordinators@sjm.com or by phone +1 972.309.8000 as soon as possible after becoming aware 
of the complaint. 

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express written consent of Abbott 
 
 DATA MANAGEMENT 
Overall, the Sponsor will be responsible for the data handling. 
 
The sponsor and/or its affiliates will be responsible for compiling and submitting all required reports to 
governmental agencies. 
 
Data will be analyzed by the Sponsor and may be transferred to the Sponsor’s locations outside of Europe 
and/or any other worldwide regulatory authority in support of a market-approval application. 
  
The Principal Investigator or institution will provide direct access to source data during and after the 
clinical study for monitoring, audits, IRB/EC review, and regulatory authority inspections. As required, 
the Principal Investigator or institution will obtain permission for direct access to source documents from 
the subject, hospital administration, and national regulatory authorities before starting the clinical study. 
 
Protection of personally identifiable information 
The Sponsor respects and protects personally identifiable information collected or maintained for 
this clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal Information 
is accessible only to and processed only on a ‘need to know’ basis, including periodic review of 
access rights, and revocation of access when an individual’s employment is terminated or the 
individual transitions to a role that does not require access to Personal Information, and appropriate 
restrictions on physical access to premises, facilities, equipment, and records containing Personal 
Information. 
 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management systems 
only pseudonymous Personal Information (key-coded) necessary to conduct the Clinical 
Investigation, such as the patient’s medical condition, treatment, dates of treatment, etc. The 
Sponsor discloses as part of the clinical investigation informed consent process that some Sponsor 
representatives still may see Personal Information at the participating sites for technical support of 
the participating physicians on the device implant or procedures, monitoring and quality control 
purposes. Confidentiality of Personal Information will be observed by all parties involved at all 
times throughout the clinical investigation. The privacy of each subject and confidentiality of 
his/her information will be preserved in reports and when publishing any data. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, 
theft, destruction, loss or alteration. Clinical Investigation data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable 
Law and industry best practices. 
 

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Data management plan 
A detailed Data Management Plan will be established to ensure consistency of the data. This 
document will include procedures used for data review, database cleaning, and issuing and 
resolving data queries. If appropriate, the DMP may be updated throughout the study duration. All 
revisions will be tracked and document controlled. 
 
 
CRF data will be captured in a validated electronic database management Oracle Clinical system 
hosted by Abbott.  
 
Only authorized site personnel will be permitted to enter the data on paper CRFs provided by 
Abbott.  
 
Document and data control 
9.3.1 
Traceability of documents and data 
The Investigator shall ensure accuracy, completeness, legibility, and timeliness of the data  
reported to the sponsor on the CRFs and in all required reports. Where copies of the original source 
document as well as printouts of original electronic source documents are retained, these shall be 
signed and dated by a member of the investigation site team with a statement that it is a true 
reproduction of the original source document. 
9.3.2 
Recording data 
Source documents shall be created and maintained by the investigation site team throughout the 
clinical study. The data reported on the CRFs shall be derived from, and be consistent with, these 
source documents, and any discrepancies shall be explained in writing. 
 
The CRFs shall be validated by the Principal Investigator or designee. In case of modifications 
after the validation, the CRFs should be re-approved by the Investigator or designee. 
 MONITORING  
It is the responsibility of Abbott, as the sponsor of the study, to ensure the study is conducted, recorded, 
and reported according to the approved protocol, subsequent amendment(s), applicable regulations, and 
guidance documents. Monitoring will be conducted according to the Abbott Clinical Monitoring standard 
operating procedure. 
 
Prior to beginning the study, Abbott will contact the Investigator or designee to discuss the study and data 
requirements. An Abbott monitor will periodically review the subject records and associated source 
documents.  
 
The Investigator shall make subject and study records available to the clinical monitor for monitoring.   
 REGULATORY INSPECTIONS 
The Investigator and/or delegate should contact Abbott immediately upon notification of a governmental 
agency inspection at the site. A clinical monitor or designee will assist the Investigator and/or delegate in 
preparing for the audit. 
 

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An Investigator who has authority to grant access will permit authorized governmental agency employees, 
at reasonable times and in reasonable manner, to enter and inspect any establishment where devices are 
held (including any establishment where devices are used or where records or results are kept). 
 
An Investigator, or any person acting on behalf of such a person with respect to the study, will permit 
authorized governmental agency employees, at reasonable times and in reasonable manner, to inspect and 
copy all records relating to the study. 
 
An Investigator will permit authorized governmental agency employees to inspect and copy records that 
identify subjects, upon notice that governmental agency has reason to suspect that adequate informed 
consent was not obtained, or that reports required to be submitted by the investigator, to the Sponsor or 
IRB/EC have not been submitted or are incomplete, inaccurate, false, or misleading. 
 
STATISTICAL CONSIDERATIONS 
 Statistical design, hypotheses, method and analytical procedures 
This is a prospective, multicenter, and single arm study. 
• 
Analysis for primary endpoint 
The primary endpoint is the event rate of MRI scan-related adverse events. The hypothesis is 
formally expressed as:  
H0: MRI scan-related adverse event rate ≥ 10% 
H1: MRI scan-related adverse event rate < 10% 
MRI-scan related adverse event rate will be summarized as the proportion of subjects who have of 
MRI-scan related events. The primary endpoint will be tested at the 5% significance level. The null 
hypothesis will be rejected if the 95% UCB for MRI scan-related adverse event rate is less than 
0.10. Confidence intervals will be calculated based on the Clopper-Pearson exact method for 
binomial proportion. 
The performance goal of 10% is based on performance goals used by historical MRI safety 
studies.14-17 
• 
Analysis for secondary endpoint 
The success of each of secondary endpoint will be summarized as the number of success and its 
percentage, together with its 95% confidence interval estimated using Clopper-Pearson exact 
method for binomial distribution. 
 Sample size 
The sample size estimation is based on the study design, the purpose of the study, and the primary 
endpoint, namely the MRI scan-related adverse event rate. 
The performance goal for MRI scan-related adverse event rate is 10%. Assuming using MRI 
conditional SCS systems, the MRI scan-related adverse event rate would achieve 1%. A sample 
size of 46 scans will be able to provide 80% power at one-sided significant level of 5% for this 
endpoint. Data from only 1 scan per subject will be collected in the study, so a total of 46 subjects 
will be enrolled and scanned. Assuming the dropout rate between the enrollment and the MRI scan-
visit is about 5%, the total expected sample size is 49 (46/0.95). The sample size was calculated 
using SAS version 9.3. 

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 Pass/fail criteria to be applied to the results of the clinical study 
Not applicable 
 The provision for an interim analysis 
Not applicable 
 Criteria for the termination of the clinical study on statistical grounds 
Not applicable 
 Procedures for reporting any deviation(s) from the original statistical plan 
Any deviations from the statistical analysis plan will be documented. 
 The specification of subgroups for analysis 
Not applicable 
 Procedures that take into account all the data 
All subjects who have signed an Informed Consent will be considered enrolled in the clinical 
investigation (refer to Section 4.8.2). However, it is anticipated that there will be subjects who are 
enrolled in the study but will not be included in the primary endpoint analysis, such as: 
• 
Subjects who are enrolled but do not meet baseline inclusion or meet exclusion criteria before 
the MRI scan; these are considered as screen failures  
• 
Subjects who are enrolled but do not receive a MRI scan 
 The treatment of missing, unused or spurious data, including drop-outs and withdrawals 
No imputation technique will be used, unless specified in the guidelines of the questionnaire data. 
 The exclusion of particular information for the testing of the hypothesis 
Not applicable 
 The minimum and maximum number of subjects to be included for each center 
This study is expected to enroll 49 subjects who are previously implanted with a Proclaim Elite or 
Prodigy MRI neurostimulator at up to 30 centers. From a statistical perspective, there is no 
expectation for heterogeneity across centers, therefore the minimum number of subjects required 
from enrolling centers is 1 and the maximum number of subjects is 49. 
 
DOCUMENT RETENTION 
The Principal Investigator (PI) will maintain all clinical study documents from prior, during, and (as 
specified) after the clinical study on file at the site for a minimum of 15 years after the termination of this 
study, longer as per local laws, or when it is no longer needed to support a marketing application, 
whichever is later.  
The PI must contact the sponsor prior to destroying or archiving off-site any records and reports pertaining 
to this study to ensure that they no longer need to be retained on-site. 
All original subject files must be stored for the longest possible time permitted by the regulations at the 
hospital, research institute, or practice in question. If archiving can no longer be maintained at the site, the 
Investigator will notify the sponsor.  

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All data and documents will be made available on request of the relevant authorities in case of an audit. 
The sponsor will archive and retain all essential clinical study documents from prior, during and (as 
specified) after the clinical study as per requirements.  
 AMENDMENTS TO CLINICAL INVESTIGATIONAL PLAN 
Study related documents such as, the Investigator Brochure (IB), Report of Prior Investigations (RPI), 
CIP, CRFs, Informed Consent form and other subject information, or other clinical study documents will 
be amended as needed throughout the clinical study, and a justification statement will be included with 
each amended section of a document. Proposed amendments to the CIP will be agreed upon between the 
Sponsor and the coordinating Investigator (if applicable).  
The amendments to the CIP and the subject’s Informed Consent will be notified to, or approved by, the 
IRB/EC and regulatory authorities, if required. The version number and date of amendments will be 
documented. 
The amendment will identify the changes made, the reason for the changes, and if it is mandatory or 
optional to implement the amendment. 
Any amendment affecting the subject requires that the subject be informed of the changes and a new 
consent be signed and dated by the Investigator at the subject’s next follow up. 
Changes to, or formal clarifications of, the CIP will be documented in writing and provided to the 
Investigators. This information will be incorporated when an amendment occurs. 
 
INVESTIGATION SUSPENSION OR TERMINATION 
 Premature termination of the clinical study  
The Sponsor reserves the right to stop the study at any stage with appropriate written notice to the 
Investigator.  
 
Possible reasons for early termination of the study by the sponsor, either at local, national or 
international level, may include, but are not limited to: 
 
• 
The device / therapy fails to perform as intended 
• 
Occurrence of USADE which cannot be prevented in future cases 
• 
Sponsor’s decision  
• 
Request from regulatory bodies 
• 
Request of Ethics Committee(s)  
• 
Concern for subject safety and welfare 
• 
Failure to secure subject Informed Consent prior to any investigational activity 
• 
Failure to report unanticipated adverse device effects within 72 hours to Abbott and the EC 
• 
Repeated non-compliance with this CIP or the Clinical Trial Agreement 
• 
Inability to successfully implement this CIP 
• 
Violation of the Declaration of Helsinki 2008 (refer to Appendix C) 
• 
Violation of applicable national or local laws and regulations 
• 
Falsification of data, or any other breach of ethics or scientific principles 
 
The study will be terminated according to applicable regulations. 

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The Investigator may also discontinue participation in the clinical study with appropriate written 
notice to the Sponsor. 
 
Should either of these events occur, the Investigator will return all documents to the sponsor, 
provide a written statement as to why the premature termination has taken place, and notify the 
IRB/EC and/or the Competent Authority (if applicable). Follow-up for all enrolled subjects will be 
as per routine care. 
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical study at the investigational sites for which they are responsible.  
 
If suspicion of an unacceptable risk to subjects arises during the clinical study, or when so instructed 
by the IRB/EC or regulatory authority, Abbott may suspend the clinical study as appropriate while 
the risk is assessed. Abbott will terminate the clinical study if an unacceptable risk is confirmed.  
 
Abbott will consider terminating or suspending the participation of a particular investigational site 
or Investigator in the clinical study if monitoring or auditing identifies serious or repeated 
deviations on the part of an Investigator.  
 
If suspension or premature termination occurs, the terminating party will justify its decision in 
writing and promptly inform the other parties with whom they are in direct communication. The 
Principal Investigator and Abbott will keep each other informed of any communication received 
from IRB/EC or regulatory authority.  
 
If for any reason Abbott suspends or prematurely terminates the study at an individual 
investigational site, Abbott will inform the responsible regulatory authority, as appropriate, and 
ensure that the IRB/EC are notified, either by the Principal Investigator or by Abbott. If the 
suspension or premature termination was in the interest of safety, Abbott will inform all other 
Principal Investigators.  
 
If suspension or premature termination occurs, Abbott will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following up the 
subjects enrolled in the clinical study, and the Principal Investigator or authorized designee will 
promptly inform the enrolled subjects at his/her investigational site, if appropriate.   
When Abbott concludes an analysis of the reasons for the suspension, implements the necessary 
corrective actions, and decides to lift the temporary suspension, Abbott will inform the Principal 
Investigators, IRB/EC, or regulatory authority, where appropriate, of the rationale, providing them 
with the relevant data supporting this decision.  
 
Concurrence will be obtained before the clinical study resumes from the IRB/EC or regulatory 
authority where appropriate.  
 
If subjects have been informed of the suspension, the Principal Investigator or authorized designee 
will inform them of the reasons for resumption. 

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15.1.1 
Study conclusion 
The study will be concluded when: 
• 
All sites are closed AND 
• 
The final report generated by Abbott has been provided to sites or Abbott has provided formal 
documentation of study closure. 
 
PUBLICATION POLICY 
The results of the clinical study will be submitted, whether positive or negative for publication.  
 
A ‘Publication Agreement’ will be signed between the Principal Investigator and the Sponsor either as a 
separate Publication Agreement or within the Clinical Trial Agreement. 
 
For more information on publication guidelines, please refer to the International Committee of Medical 
Journal Editors (ICMJE) on www.icmje.org. 
 
This study will be posted on ClinicalTrials.gov and results will be posted on ClinicalTrials.gov as required.  
 
BIBLIOGRAPHY 
 
1. 
Deer TR, Mekhail N, Provenzano D, et al. The appropriate use of neurostimulation: avoidance and 
treatment of complications of neurostimulation therapies for the treatment of chronic pain. 
Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014;17:571-597. 
2. 
de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal 
cord stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes 
Complications. 2009;23:40-45. 
3. 
Duyvendak W. Spinal cord stimulation with a dual quadripolar surgical lead placed in general 
anesthesia is effective in treating intractable low back and leg pain. Neuromodulation. 
2007;10(2):113-119. 
4. 
Kumar A, Felderhof C, Eljamel MS. Spinal cord stimulation for the treatment of refractory 
unilateral limb pain syndromes. Stereotact Funct Neurosurg. 2003;81:70-74. 
5. 
Leveque JC, Villavicencio AT, Bulsara KR, Rubin L, Gorecki JP. Spinal cord stimulation for 
failed back surgery syndrome. Neuromodulation. 2001;4(1):1-9. 
6. 
North RB, Kidd DH, Olin J, et al. Spinal cord stimulation for axial low back pain: a prospective, 
controlled trial comparing dual with single percutaneous electrodes. Spine (Phila Pa 1976). 
2005;30(12):1412-1418. 
7. 
Forouzanfar T, Kemler MA, Weber WE, Kessels AG, van Kleef M. Spinal cord stimulation in 
complex regional pain syndrome: cervical and lumbar devices are comparably effective. Br J 
Anaesth. 2004;92(3):348-353. 
8. 
Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Effect of spinal 
cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of 
patients in a randomized controlled trial. J Neurosurg. 2008;108:292-298. 
9. 
Katayama Y, Yamamoto T, Kobayashi K, Kasai M, Oshima H, Fukaya C. Motor cortex 
stimulation for phantom limb pain: comprehensive therapy with spinal cord and thalamic 
stimulation. Stereotact Funct Neurosurg. 2001;77:159-162. 

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This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott 
 
10. 
Amann W, Berg P, Gersbach P, Gamain J, Raphael JH, Ubbink DT. Spinal cord stimulation in the 
treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral 
Vascular Disease Outcome Study (SCS-EPOS). Eur J Vasc Endovasc Surg. 2003;26(3):280-286. 
11. 
Harke H, Gretenkort P, Ladleif HU, Koester P, Rahman S. Spinal cord stimulation in postherpetic 
neuralgia and in acute herpes zoster pain. Anesth Analg. 2002;94:694-700. 
12. 
Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic 
back and leg pain/failed back surgery syndrome: results of a systematic review and meta-analysis. 
J Pain Symptom Manage. 2006;31:S13-19. 
13. 
Desai MJ, Hargens LM, Breitenfeldt MD, et al. The rate of magnetic resonance imaging in patients 
with spinal cord stimulation. Spine (Phila Pa 1976). 2015;40(9):E531-537. 
14. 
Awad K, Griffin J, Crawford TC, et al. Clinical safety of the Iforia implantable cardioverter-
defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance 
imaging scanning conditions. Heart Rhythm. 2015;12(10):2155-2161. 
15. 
Sutton R, Kanal E, Wilkoff BL, et al. Safety of magnetic resonance imaging of patients with a new 
Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008;9:68. 
16. 
Gold MR, Sommer T, Schwitter J, et al. Full-Body MRI in Patients With an Implantable 
Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. 
2015;65(24):2581-2588. 
17. 
Ching CK, Chakraborty RN, Kler TS, et al. Clinical safety and performance of a MRI conditional 
pacing system in patients undergoing cardiac MRI. Pacing Clin Electrophysiol. 2017;40(12):1389-
1395. 
 
 

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APPENDIX A: ABBREVIATIONS 
 
 
 
 
 
Abbreviation 
Term 
ADE 
AE 
ASADE 
CA 
CIP 
CRF 
DD 
DMP 
EC 
GP 
IB 
ICMJE 
IFU 
IRB 
ISB 
ISO 
MP 
NA 
PI 
PMCF 
RDC 
SADE 
SAE 
SJM 
US 
USADE 
WMA 
Adverse Device Effect 
Adverse Event 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Investigational Plan 
Case Report Form 
Device Deficiency  
Data Management Plan 
Ethics Committee 
General Practitioner 
Investigator Brochure  
International Committee of Medical Journal Editors 
Instructions for Use 
Institutional Review Board  
Investigator Site Binder 
International Organization for Standardization 
Monitoring Plan 
Not Applicable 
Principal Investigator 
Post Market Clinical Follow Up 
Remote Data Capture  
Serious Adverse Device Effect 
Serious Adverse Event 
St. Jude Medical 
United States 
Unanticipated Serious Adverse Device Effect 
World Medical Association 
 

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APPENDIX B: CIP REVISION HISTORY 
 
Revision History 
Amendment 
Number 
Version Date 
Rationale 
Details 
Not 
Applicable. 
Internal 
Document. 
1.0 
26 MAY2015 
This version of the CIP 
was submitted to TÜV. 
NA 
Not 
Applicable. 
Internal 
Document. 
1.1 
13 AUG2015 
Additional internal 
comments: 
  
-Battery recharging data added as 
an option at unscheduled and 
additional surgery visits. 
-MRI Scan Form was removed as 
this is not applicable. 
-Clinical Coordinating 
Investigator signatory has been 
removed since there will not be a 
CCI assigned to the study. 
Not 
Applicable. 
Internal 
Document. 
2.0 
14 SEP 2015 
-Additional internal 
comments on spelling. 
-Data will be collected 
via paper CRF 
-Sample Size was 
recalculated 
Spelling corrections have been 
made. 
References to eCRF and EDC 
have been removed. 
Sample size has been updated. 
Not 
Applicable 
Internal 
Document 
3.0 
15 JAN2015 
Additional internal 
comments on study 
activities and data 
points. 
Study activities and data points 
have been revised to align with 
the objectives and endpoints of 
the study.  
Not 
applicable 
4.0 
18 FEB2016  
The word 
‘interventional’ was 
replaced by 
‘observational’. 
 
 
 
Section 9.0 Data 
Management has been 
updated.  
The procedures and tests applied 
in this study would have been 
applied as standard of care for 
subjects that are clinically 
indicated to undergo a MRI scan 
and being followed up.  
  
Reference to the EU-US Swiss 
Safe Harbor framework has been 
removed since it is no longer 
valid. Most current verbiage was 
added.  
1 
D 
27 FEB 2019 
Enrollment criteria now 
allow subjects to 
receive an MRI scan 
solely for research 
purposes to increase 
enrollment rate.  
Requirement that MRI be 
conducted as standard of care has 
been removed. Population now 
allows MRI scans as standard of 
care or for the sole purpose of this 
study. 

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This study will support 
MRI labeling for 
Proclaim as well as 
Prodigy devices.  
 
 
 
 
 
Unification of CIP 
across study regions. 
 
 
Abbott/St. Jude 
Medical integration has 
modified some clinical 
study-related 
templates/practices. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Estimated time to enroll patients 
has been updated from 10 to 6 
years. 
 
Proclaim Elite devices have been 
added to the list of devices 
included in this study and the 
study title has been updated. 
 
The inclusion criteria have been 
updated to clarify which devices 
are eligible. 
 
Additional relevant clarifications 
have been made throughout the 
document 
 
Addition of “malignant tumor” as 
a possible SAE. 
 
References to St. Jude Medical 
have been changed to Abbott 
where appropriate. 
 
Table of devices has been 
expanded with additional details. 
 
Clarified Abbott post-market 
surveillance policy regarding 
device deficiencies. 
 
A clinical events committee has 
been added to reduce bias. 
 
Section 8.2.1 clarifies how the 
relationship between adverse 
events and medical devices 
should be decided. 
 
Section 5.0 has been split into 
multiple sub-sections. 
 
Guidance for SAE reporting has 
been updated. 
 

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Data collection has 
been revised. 
 
 
 
 
 
Clarification. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notified Body has been 
updated. 
Deidentified DICOM image files 
have been added to data collection 
at the MRI scan visit. The image 
tags will serve a source for scan 
details that are otherwise difficult 
to capture.  
 
Background and rationale was 
expanded with appropriate 
citations.  
 
References to neurostimulation 
systems have been replaced with 
SCS or device names where 
appropriate to clarify the scope of 
this study. 
 
Added a list of unavoidable MRI 
events that are not reportable 
unless condition worsens or 
duration exceeds expected 
timeframe. 
 
Highlighted MRI-related adverse 
events in the list of reportable 
events. 
 
Added citations for 10% safety 
performance goal. 
 
Section 9.1 has been added to 
expand the description of personal 
information protection. 
 
Various typos and grammatical 
errors have been corrected. 
 
Version identifier has been 
changed to “D” for consistency 
with document control processes. 
 
References to TUV have been 
replaced by BSI after project 
transfer completed in December 
2018. 
 

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2 
D 
25 JUL 2019 
US sites are now 
allowed in the study to 
increase enrollment and 
to increase Abbott’s 
ability to evaluate 
Proclaim devices (more 
commonly used at US 
sites). 
 
 
 
Enrollment rate was 
adjusted following the 
addition of US sites. 
The estimated time 
needed to enroll this 
subject population 
remains the same in 
current update (6 years) 
because enrollment in 
previous protocol 
update (March 2019) 
did not reflect the 
situation in the field. 
 
Reporting subject death 
to applicable committee 
according to 
geographic location. 
 
 
 
Update of informed 
consent language 
according to the latest 
Abbott standard and in 
view of adding US sites 
to the study. 
 
 
Device functionality 
check further specified. 
Wording added that 
supplements MRI 
Procedure Information 
Manual to allow 
Section 4.2 now clarifies that the 
study will be conducted in up to 
10 sites in the US, in addition to 
the approximately 20 sites in 
Europe.  
 
Similarly, Section 12.11 is 
updated to indicate that subjects 
will be enrolled at up to 30 
centers. 
 
Section 4.4 was updated to 
indicate that, with the addition of 
US sites, Abbott expects 
enrollment rate for patients 
requiring MRIs with an eligible 
MR conditional device to be no 
more than 10 subjects per year.  
 
 
 
 
 
 
 
In case of death, the investigator 
will need to notify the IRB (for 
US sites) or EC (for EU sites) per 
IRB/EC policy. EC has been 
added to this version of the 
protocol (Section 8.2.1). 
 
Informed consent section (Section 
4.9.1) has been updated.  
 
Special Circumstances for 
Informed Consent (Section 
4.9.1.1) has been updated with US 
HIPAA compliant statement. 
 
Section 6.2 and Section 6.5.1 has 
been updated to specify that data 
collection regarding device 
functionality includes impedance 
check, performed before the MRI 
scan. This can only be done when 

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impedance check at 
every MRI scan. 
the Clinician Programmer (for 
Proclaim devices) or Rapid 
Programmer (for Prodigy devices) 
is present. This requirement at 
every MRI scan has been added to 
the section describing the MRI 
Procedure Information Manual 
(Section 5.4). 

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Appendix C: Declaration of Helsinki 
The most current version of the document will be followed. 
 
 

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express written consent of Abbott 
 
Appendix D: Questionnaires  
The questionnaire used in this study will be kept under a separate cover and is available upon request.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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express written consent of Abbott 
 
Appendix E: Device Manual  
The manuals for the devices used in this study will be kept under a separate cover and are available upon 
request. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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express written consent of Abbott 
 
Appendix F: List of Clinical Investigation Sites and IRB/EC 
A list of Clinical Investigational sites and IRB/EC will be kept under a separate cover and is available 
upon request.  
 
 

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express written consent of Abbott 
 
Appendix G: Sample Informed Consent 
The sample informed consent will be kept under a separate cover and is available upon request.  
 
 
 

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 Appendix H: Case Report Forms 
The case report forms will be kept under a separate cover and are available upon request.