Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads
Phase: NA
Conditions: Chronic Pain
Sponsor: Boston Scientific Corporation

THESE DOCUMENTS ARE THE PROPERTY OF BOSTON SCIENTIFIC CORPORATION AND SHALL NOT BE REPRODUCED, 
DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN 
CONSENT OF BOSTON SCIENTIFIC CORPORATION. 
Boston Scientific 
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CoverEdge Algorithm 
Study to Characterize the Effects of Programming Features of the Boston Scientific 
Precision SpectraTM Spinal Cord Stimulator System Using the CoverEdgeTM Surgical 
Leads 
CLINICAL PROTOCOL 
A4057 
Sponsored By 
Boston Scientific Corporation 
Neuromodulation 
25155 Rye Canyon Loop 
Valencia, CA 91355 
United States of America 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 

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Contact Information 
Role 
Contact  
Clinical Contact 
Kristen Lechleiter, M.S. 
Principal Clinical Research Scientist 
Boston Scientific Corporation 
Neuromodulation 
25155 Rye Canyon Loop 
Valencia, CA 91355 
United States of America  
Kristen.lechleiter@bsci.com 
1-602-300-8267 
Coordinating 
Principal 
Investigators 
Not applicable 
 
Original Release: 11 MAY 2015 
Current Version: 11 MAY 2015

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2. Protocol Synopsis 
Study to Characterize the Effects of Programming Features of the Boston Scientific 
Precision SpectraTM Spinal Cord Stimulator System Using the CoverEdgeTM Surgical 
Leads 
Primary 
Objective 
To characterize the effects of programming features of the Boston 
Scientific Precision Spectra™ Spinal Cord Stimulator System using the 
CoverEdgeTM surgical lead. 
Test Device 
All commercially approved Boston Scientific CoverEdge surgical leads 
compatible with Precision Spectra neurostimulation system.  
Study Design 
Prospective, on-label, multi-center, non-randomized, exploratory, single-
arm 
Planned 
Number of 
Subjects 
Up to 15 enrolled subjects, to yield approximately 10 subjects completing 
the Programming Visit 
Planned 
Number of 
Centers / 
Countries 
Up to 3 sites in the US 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
 

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Study to Characterize the Effects of Programming Features of the Boston Scientific 
Precision SpectraTM Spinal Cord Stimulator System Using the CoverEdgeTM Surgical 
Leads 
 
Follow-up 
Schedule 
Study assessments will be required, as appropriate, at the following time 
points: 
• Screening Visit (minimum 25 days post-Implantable Pulse Generator 
activation) 
• Programming Visit (up to 90 days post Screening Visit) – Day 0 
Study Duration 
Overall study duration is anticipated to take approximately 4 months from 
first patient enrolled to end of study close out activities. 
Key Inclusion 
Criteria 
IC1. 
Subject implanted, on-label, with a commercially approved 
Boston Scientific Spectra neurostimulation system and at least 
one CoverEdge or CoverEdge X surgical lead, per local directions 
for use (DFU). 
IC2. 
Subject signed a valid, IRB-approved informed consent form. 
IC3. 
Subject is 18 years of age or older when written informed consent 
is obtained. 
Key Exclusion 
Criteria 
EC1. Subject meets any contraindication in BSC neurostimulation 
system local DFU. 
EC2. Subject is currently diagnosed with cognitive impairment, or 
exhibits any characteristic, that would limit study candidate’s 
ability to assess pain relief or complete study assessments. 
 
 
 

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3. Table of Contents 
1. 
TITLE PAGE  ........................................................................................................................ 1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 3 
3. 
TABLE OF CONTENTS .......................................................................................................... 5 
3.1. Table of Figures ........................................................................................................ 8 
3.2. Table of Tables ......................................................................................................... 8 
4. 
INTRODUCTION ................................................................................................................... 9 
4.1. Chronic Pain ............................................................................................................. 9 
4.2. Spinal Cord Stimulation .......................................................................................... 9 
5. 
DEVICE DESCRIPTION ....................................................................................................... 11 
5.1. System Elements ..................................................................................................... 11 
6. 
OBJECTIVES ...................................................................................................................... 11 
6.1. Primary Objective .................................................................................................. 11 
 
 
8. 
DESIGN .............................................................................................................................. 11 
8.1. Scale and Duration ................................................................................................. 11 
8.2. Treatment Assignment .......................................................................................... 12 
8.2.1. 
Treatment ................................................................................................... 12 
8.3. Justification for the Study Design ......................................................................... 12 
9. 
SUBJECT SELECTION ......................................................................................................... 13 
9.1. Study Population and Eligibility ........................................................................... 13 
9.2. Inclusion Criteria ................................................................................................... 13 
9.3. Exclusion Criteria .................................................................................................. 13 
10. SUBJECT ACCOUNTABILITY .............................................................................................. 13 
10.1. Point of Enrollment ................................................................................................ 13 
10.2. Withdrawal ............................................................................................................. 14 
10.3. Subject Status and Classification .......................................................................... 14 

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10.4. Enrollment Controls .............................................................................................. 14 
11. STUDY METHODS .............................................................................................................. 15 
11.1. Data Collection ....................................................................................................... 15 
11.2. Screening ................................................................................................................. 15 
11.3. Informed Consent .................................................................................................. 15 
11.4. Programming Visit – Day 0 ................................................................................... 16 
Fluoroscopy ...................................................................................................................... 16 
11.5. Unscheduled visit .................................................................................................... 16 
11.6. Study Completion ................................................................................................... 17 
11.7. Source Documents .................................................................................................. 17 
12. STATISTICAL CONSIDERATIONS ....................................................................................... 17 
13. DATA MANAGEMENT ........................................................................................................ 17 
13.1. Data Collection, Processing, and Review ............................................................. 17 
13.2. Data Retention ........................................................................................................ 18 
13.3. Study Assessments .................................................................................................. 18 
13.3.1. Pain Drawing ............................................................................................. 18 
13.3.2. Pain Intensity ............................................................................................. 18 
13.3.3. Paresthesia Drawing .................................................................................. 18 
13.3.4. Fluoroscopy ............................................................................................... 19 
14. AMENDMENTS ................................................................................................................... 19 
15. DEVIATIONS ...................................................................................................................... 19 
16. DEVICE/EQUIPMENT ACCOUNTABILITY .......................................................................... 19 
17. COMPLIANCE ..................................................................................................................... 20 
17.1. Statement of Compliance ....................................................................................... 20 
17.2. Investigator Responsibilities ................................................................................. 20 
17.2.1. Delegation of Responsibility ..................................................................... 22 
17.3. Institutional Review Board/ Ethics Committee ................................................... 22 
17.4. Sponsor Responsibilities ........................................................................................ 22 
17.4.1. Role of Boston Scientific Representatives ................................................ 23 
17.5. Insurance ................................................................................................................. 23 

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18. MONITORING ..................................................................................................................... 23 
19. POTENTIAL RISKS AND BENEFITS .................................................................................... 24 
19.1. Risks Associated with Use of SCS device-programming as described in the 
protocol ................................................................................................................... 24 
19.1.1. Anticipated Adverse Device Effects Associated with SCS Device-
stimulation Programming .......................................................................... 24 
19.1.2. Anticipated Adverse Events ...................................................................... 25 
19.2. Risks associated with Typical Use of SCS ............................................................ 25 
19.3. Risks Associated with the Study Device(s) ........................................................... 26 
19.4. Risks associated with Stopping the Therapy ....................................................... 26 
19.5. Possible Interactions with Concomitant Medical Treatments ........................... 27 
19.5.1. Magnetic Resonance Imaging (MRI): ....................................................... 27 
19.5.2. Diathermy: ................................................................................................. 27 
19.5.3. Implanted Stimulation Devices: ................................................................ 27 
19.5.4. Medical Devices/Therapies: ...................................................................... 27 
19.6. Risk Minimization Actions .................................................................................... 27 
19.7. Anticipated Benefits ............................................................................................... 28 
19.8. Risk to Benefit Rationale ....................................................................................... 28 
20. SAFETY REPORTING .......................................................................................................... 28 
20.1. Definitions and Classification ............................................................................... 28 
20.2. Investigator Reporting Requirements .................................................................. 29 
20.3. Boston Scientific Device Deficiencies .................................................................... 31 
20.4. Reporting to Regulatory Authorities / IRBs / ECs / Investigators .................... 31 
21. INFORMED CONSENT ......................................................................................................... 31 
22. SUSPENSION OR TERMINATION ......................................................................................... 33 
22.1 Premature Termination of the Study ................................................................... 33 
22.1.1 
Criteria for Premature Termination of the Study ....................................... 33 
22.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval .................................................................................................. 33 
22.3 Requirements for Documentation and Subject Follow-up ................................. 33 
22.4 Criteria for Suspending/Terminating a Study Center ........................................ 34 
23. PUBLICATION POLICY ....................................................................................................... 34 

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24. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................. 34 
24.1. Subject Reimbursement ........................................................................................ 34 
24.2. Compensation for Subject’s Health Injury ......................................................... 34 
25. BIBLIOGRAPHY .................................................................................................................. 35 
26. ABBREVIATIONS AND DEFINITIONS .................................................................................. 36 
 
 
3.1. 
Table of Figures 
Figure 8.1-1: Study Design ..................................................................................................... 12 
 
3.2. 
Table of Tables 
Table 9.2-1: Inclusion Criteria ................................................................................................ 13 
Table 9.3-1: Exclusion Criteria ............................................................................................... 13 
Table 11.1-1: Data Collection Schedule ................................................................................. 15 
Table 11.7-1: Source Documentation Requirements .............................................................. 17 
Table 20.1: Adverse Event Definitions ................................................................................... 28 
Table 20.2-1: Investigator Reporting Requirements ............................................................... 29 
Table 24.2-1: Abbreviations and Definitions.......................................................................... 37 
 

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4. Introduction 
4.1. 
Chronic Pain 
Chronic pain is a significant world-wide complaint and consumes considerable healthcare 
resources and heavily impacts quality of social and working life for many.  A 2001 European 
investigation showed that 30% of patients treated in primary care facilities were treated by a 
physician for a pain complaint, and 37% of those patients (11% of total) suffered from 
chronic pain (Hasselstrom, Liu-Palmgren, & Rasjo-Wraak, 2002).  More recently an 
epidemiological study conducted in Scotland found the prevalence of chronic pain to be 48%, 
8% of which is of neuropathic origin.  The authors concluded that chronic pain is more 
prevalent than what previous studies have suggested (Torrance, Smith, Bennett, & Lee, 
2006).  In a separate European study done in 2006, 19% of adults surveyed reported suffering 
from chronic pain (Breivik, Collett, Ventafridda, Cohen, & Gallacher, 2006).  
In the 2010 report of the health and status of the nation, Health, the U.S. Center for Disease 
Control and Prevention reports that over 28% of adults suffer from non-fleeting low-back 
pain.  In patients with low-back pain, approximately half of the patients reported limitation in 
at least one basic action from the following list:  movement difficulty, emotional difficulty, 
sensory difficulty, cognitive difficulty, self-care limitation, social limitation, or work 
limitation (National Center for Health Statistics, 2011). 
 
Chronic pain can lead to a number of co-morbidities, including reduced health-related quality 
of life, reduced ability to engage in activities of daily living, increased disability, increased 
emotional depression, and weight gain due to the adoption of a sedentary lifestyle. 
4.2. 
Spinal Cord Stimulation  
Spinal cord stimulation (SCS) is a treatment option for chronic pain that has generally been 
reserved for patients who have failed multiple, and sometimes all, conservative chronic pain 
therapies.  With SCS, an implanted pulse generator (IPG) delivers electrical current to a 
lead(s) implanted in the epidural space at spinal level(s) where access can be obtained neural 
structures that are implicated in the chronic pain circuits.   Electrically stimulating these 
nerves creates a comfortable tingling sensation, known as paresthesia, that can be directed to 
the painful location to mask the sensation of pain (Kumar et al., 2006).  
SCS is effective for neuropathic pain associated with a variety of conditions, including failed 
back surgery syndrome (FBSS), which is the most common condition associated with 
chronic pain (Carter et al., 2004, Taylor et al., 2004).  For best pain relief, the paresthesia 
must be programmed to overlap the regions of pain (North et al., 1990). To achieve overlap, 
the electrode contacts are programmed based on the patient’s feedback to various 
combinations of stimulation parameters such as polarities, pulse rate, amplitude, and pulse 
width.   
Two randomized controlled trials (RCTs) have been conducted on the use of SCS to treat 
patients with FBSS. Each study demonstrated the superiority of SCS compared with the 

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alternative therapy, reoperation in one case (North et al., 2005) and conventional medical 
management (CMM), including medication, nerve blocks, physical therapy, massage, etc., in 
the other (Kumar et al., 2007).  
In a single-center study, North et al. randomized 50 patients: 24 to SCS and 26 to 
reoperation. At an average follow-up of 2.9 years, the success rate (at least 50% pain relief 
and patient satisfaction) was reported to be significantly higher among patients randomized 
to SCS (9 of 24 patients) than among those randomized to reoperation (3 of 26 patients).  
Crossover was permitted if a patient’s randomized therapy did not provide adequate pain 
relief, and significantly more patients crossed from reoperation to SCS (14 of 26) than from 
SCS to reoperation (5 of 24). Six of the reoperation crossovers achieved success with SCS, 
bringing the success rate to 15 of 38 who received SCS as a final treatment.  None of the 
patients who failed SCS achieved success with reoperation (3 of 31 who received reoperation 
as a final treatment achieved success).  
North et al. then used data from this study to compare the cost of SCS versus reoperation 
over a 2.9-year follow-up period and demonstrated that SCS was the least expensive and was 
dominant in terms of cost-effectiveness and cost-utility (North et al., 2007).   
In a separate, international, multi-center RCT, Kumar et al. randomized 100 patients:  48 to 
CMM and 52 to SCS plus CMM (Kumar et al., 2007).  At 6 months, patients randomized to 
SCS achieved significantly greater pain relief and improved functional capacity and health-
related quality of life compared with patients randomized to CMM. The patients randomized 
to SCS who actually received SCS (42 of 52) and were followed for 24 months reported 
significantly improved leg pain relief, functional capacity, and quality of life compared with 
their pre-treatment status (Kumar et al., 2008).  While initial SCS costs were greater than 
CMM costs, by 6 months post-randomization, health-related quality of life scores were 
preferentially improved for the SCS group.  Thus, the authors inferred that SCS cost-
effectiveness studies must examine costs and quality of life data beyond six months to paint 
an accurate picture (Manca et al., 2008). 
The results of these RCTs provide evidence that SCS is effective and cost effective in 
relieving chronic neuropathic pain associated with FBSS.  North et al. also indicate that SCS 
might provide the best outcome and economic value for patients who are eligible for both 
SCS and reoperation (North et al., 2007).  The results of North’s single-center RCT, 
however, have not been confirmed by a multi-center RCT that reflects the advances in 
surgical practice and in SCS that might have changed the comparative efficacy of these 
procedures.   
In 2004, FDA approved the Boston Scientific Corporation (BSC) Precision® SCS system as 
an aid in the management of chronic intractable pain of the trunk and/or limbs.  The 
Precision system received CE mark in 2005 for treatment of chronic intractable pain.   
The results of a multi-center, non-randomized feasibility study conducted with this system 
demonstrated more than 50% pain relief through a maximum follow-up of 18 months, but the 

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single-arm design and small number of subjects enrolled limit the strength of the conclusions 
(Oakley et al., 2007). 
5. Device Description 
5.1. 
System Elements 
This study includes commercially approved Boston Scientific Precision Spectra 
neurostimulation system and CoverEdge surgical leads.  
6. Objectives 
6.1. 
Primary Objective 
To characterize the effects of programming features of the Boston Scientific Precision 
Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdgeTM surgical lead. 
7. 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
8. Design 
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study. 
8.1. 
Scale and Duration 
This study will be conducted in up to 3 centers in the U.S and will enroll up to 15 subjects 
who have been implanted with a Boston Scientific Precision Spectra neurostimulation system 

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and at least one CoverEdge surgical lead.  The study requires a screening visit and a 
programming visit.  Overall study duration is planned for approximately 6 months from first 
patient enrolled to completion of end of study close out activities.  Figure 8.1-1 shows the 
study design   
Figure 8.1-1: Study Design 
  
8.2. 
Treatment Assignment 
Consecutive eligible patients who consent to participation and have met all of the inclusion 
and none of the exclusion criteria will be enrolled and assigned a unique subject identifier.  
8.2.1. Treatment  
The study treatment will consist of commercially available neurostimulation program settings 
for subjects implanted with any commercially approved Boston Scientific Precision Spectra 
neurostimulator and CoverEdge surgical lead for pain.  
8.3. 
Justification for the Study Design 
All devices used in this study are approved for commercial release. 
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study. 
The endpoints of this study are intended to observe the paresthesia paradigms elicited by 
programming configurations for on-label use of the BSC Precision Spectra neurostimulation 
system and CoverEdge surgical leads. The results of this study will also help Boston 
Scientific guide the development of next generation programming algorithms. 
A prospective study design will ensure that identical procedures are followed for data capture 
and review. 
A multi-center design will minimize the impact on the results due to specific surgical 
placement and intra-operative techniques as well as to minimize bias that may result from 
differences in patient selection, regional differences in the patient demographic, and patient 
management.   
This study does not require blinding since there is no treatment comparison based on 
outcomes and all subjects will be undergoing identical procedures. All end-points are 
exploratory and the design does not require statistical power.  
Screening visit 
•
min 25 days post IPG 
implant 
•
Written Informed 
Consent 
Programming visit 
•
min 3 test configurations 
0-90 days 

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9. Subject Selection  
9.1. 
Study Population and Eligibility  
Subjects are established patients in a medical practice (e.g. pain management, surgical, 
physical medicine and rehabilitation) and have received neurostimulation therapy to treat 
their pain condition utilizing a commercially-approved BSC neurostimulation system with a 
CoverEdge surgical lead.  
9.2. 
Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 9.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 9.3) is 
met.  
Table 9.2-1: Inclusion Criteria 
Clinical 
Inclusion 
Criteria 
IC1. 
Subject implanted, on-label, with a commercially approved Boston 
Scientific Spectra neurostimulation system and at least one CoverEdge or 
CoverEdge X surgical lead, per local directions for use (DFU). 
IC2. 
Subject signed a valid, IRB-approved informed consent form. 
IC3. 
Subject is 18 years of age or older when written informed consent is 
obtained. 
Abbreviations: DFU - directions for use, IRB - Institutional Review Board 
9.3. 
Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 9.3-1) will be excluded from this 
clinical study. 
Table 9.3-1: Exclusion Criteria 
Clinical 
Exclusion 
Criteria 
EC1. Subject meets any contraindication in BSC neurostimulation system 
local DFU. 
EC2. Subject is currently diagnosed with cognitive impairment, or exhibits 
any characteristic, that would limit study candidate’s ability to assess pain 
relief or complete study assessments. 
Abbreviations: BSC - Boston Scientific Corporation,   DFU - Directions For Use 
 
10. Subject Accountability 
10.1. Point of Enrollment 
The point of enrollment is the time at which a subject signs and dates the valid, IRB/EC-
approved informed consent form.  No study-related procedures or assessments can take place 
until the informed consent form is signed.    

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10.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems 
related to study device safety or performance, the investigator shall ask for the subject’s 
permission to follow his/her status/condition outside of the clinical study.   
Reasons for withdrawal include 
• physician discretion,  
• subject choice to withdraw consent,  
• subject’s failure to meet sub-study inclusion or exclusion criteria after enrollment 
• lost to follow-up, or  
• death 
While study withdrawal is discouraged, subjects may withdraw from the study at any time, 
with or without reason, and without prejudice to further treatment. 
All applicable case report forms (CRFs) up to the point of subject withdrawal and an “End of 
Study” form must be completed.  Any subject deemed “lost to follow-up” should have a 
minimum of three documented attempts to contact him/her prior to completion of the “End of 
Study” form.   
Additional data may no longer be collected after the point at which a subject has been 
withdrawn from the study or withdraws consent, for whatever reason.  All open adverse 
events should be closed or documented as unresolved.  Data collected up to the point of 
subject withdrawal may be used and analyzed. 
10.3. Subject Status and Classification 
A subject is considered enrolled after a signed informed consent form (ICF) has been 
obtained. Study participation will end when each enrolled subject completes their study 
visits, withdraws, or at most 90 days after the Screening Visit if a Programming Visit is not 
completed.   
10.4. Enrollment Controls 
At the time when the study-wide cap of 15 enrolled subjects is reached, further enrollment 
into the study will cease. The sponsor will notify all centers when approximately 10 subjects 
have been enrolled to alert investigators that enrollment will soon cease. The correspondence 
will also outline the specific activities to minimize the risk of enrollment after the protocol-
specified cap of 15 enrolled subjects has been reached. 
 
10.5. End-of-Study Action Plan 
 

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• Written informed consent must be recorded appropriately by means of the subject’s 
dated signature.   
• The consent process must be documented in the subject’s medical chart. 
11.4. Programming Visit – Day 0 
The Programming Visit will occur in the physician’s office. The clinician may perform 
routine clinical care prior to any changes in programming. 
Fluoroscopy 
If not performed as part of routine care, fluoroscopy should be done prior to any changes in 
programming. Both an AP and a lateral view are recommended to determine the location of 
the implanted lead. 
Prior to any changes in programming, the following assessments will be completed: 
• Pain Drawing 
• Pain Intensity 
The subject will be asked to complete their pain drawing and intensity assessment based on 
their recollection of pain. Upon completion of the above mentioned assessments, subjects 
will be programmed to receive multiple program settings by the site staff with the assistance 
of the sponsor’s personnel. 
The following assessments will be completed based on each program setting: 
• Perception and Discomfort Thresholds during programming 
• Paresthesia Drawing 
Multiple program settings will be tested and the above assessments completed for each 
configuration.  The total number of configurations tested will depend on the subject’s 
tolerance.  A minimum of 3 configurations will be tested for each subject. 
Following completion of programming, test electrical configurations will be documented in 
the study records.  
At the preference or request of the subject, test configurations may be saved on their device 
to be used at home.  This will be documented on the CRF. 
11.5. Unscheduled visit 
Unscheduled visits may be made at any time for reprogramming.  Each unscheduled visit 
should be documented on CRF with the reason for the visit stated. Programming information 
and settings should be collected.  
 

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11.6. Study Completion 
The study will be completed after the subject’s visit. The study will be considered complete 
once all subjects have completed Programming Visit and all site and study close-out 
activities have been completed. 
11.7. Source Documents 
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 center team with a statement that it is a true reproduction of the original source 
document. All source documentation will be retained at the study site. Examples of source 
documents include, but are not limited to the following: 
Table 11.7-1: Source Documentation Requirements 
Requirement 
Disposition 
Informed Consent Form 
Retained at study site 
Consent Process Documentation 
Retained at study site 
Inclusion & Exclusion Criteria Documentation  
Retained at study site 
Medical Records 
Retained at study site 
Questionnaires  
Retained at study site 
Imaging films/prints (if applicable) 
Retained at study site 
Programming printouts from Clinician 
Programmer following programming/testing (if 
applicable) 
Retained at study site 
Technical Source Forms  
Retained at study site 
12. Statistical Considerations 
This feasibility study is exploratory in nature and thus no statistical powered end-points are 
included. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded on paper case report forms (CRFs) which will be provided by 
BSC. The data reported on the CRFs shall be derived from source documents and shall be 
consistent with these source documents. An exception to this requirement is when data must 
be recorded directly on the CRF. For example, the questionnaire filled out by the patient 
describing the details of their pain. Any discrepancies should be explained in writing. Any 
change or correction made to the clinical data will be dated, initialed and explained, if 
necessary, and shall not obscure the original entry. A written audit trail shall be maintained 

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which will be made available for review by BSC or its representative. Sites will be trained to 
complete the CRF. 
13.2. Data Retention 
The Investigator or Investigational site will maintain, at the investigative site, in original 
format all essential study documents and source documentation that support the data 
collected on the study subjects in compliance with ICH/GCP guidelines.  Documents must be 
retained for at least 2 years after the last approval of a marketing application or until at least 2 
years have elapsed since the formal discontinuation of the clinical investigation of the 
product. These documents will be retained for a longer period of time by agreement with 
BSC or in compliance with other local regulations. It is BSC’s responsibility to inform the 
Investigator when these documents no longer need to be maintained. The Investigator will 
take measures to ensure that these essential documents are not accidentally damaged or 
destroyed. If for any reason the Investigator withdraws responsibility for maintaining these 
essential documents, custody must be transferred to an individual who will assume 
responsibility and BSC must receive written notification of this custodial change.  
13.3. Study Assessments 
13.3.1. Pain Drawing 
Pain areas will be collected on a paper form on which the subject draws their areas of 
pain.  Subjects shall be instructed to complete the drawing as follows:  
• Completely fill in all areas of pain, regardless of relative intensity and avoid alternate 
techniques for marking pain (e.g. circling areas of pain, hash marks, pinpoint 
markings to indicate lower pain intensity)   
• Avoid marking outside the body lines or within the data field box 
13.3.2. Pain Intensity 
Pain Intensity is a questionnaire assessing the intensity of the subject’s different areas of 
pain.  Pain intensity is expressed on a 0 – 10 numerical rating scale (NRS), where 0 
indicates “no pain” and 10 indicates “pain as bad as you can imagine”. 
13.3.3. Paresthesia Drawing 
Paresthesia coverage will be collected by asking subjects to draw all areas where they 
currently experiencing any amount of neurostimulation-induced paresthesia.   
Subjects shall be instructed to complete the drawing as follows:  
• Completely fill in all areas of paresthesia, regardless of relative intensity and avoid 
alternate techniques for marking paresthesia (e.g. circling areas of paresthesia, hash 
marks, pinpoint markings to indicate lower paresthesia intensity)   
• Avoid marking outside the body lines or within the data field box 

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• Be aware of the left and right orientation markers on both the front and back images 
13.3.4. Fluoroscopy 
It is recommended that both AP and lateral images be performed to document lead 
position, if not part of routine care.  
14. Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
IRB/EC/FDA/CA) of the revised protocol must be obtained prior to implementation. 
15. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor. Sites may also be required to 
report deviations to the IRB/EC, per local guidelines and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the sponsor. 
Deviations will be classified according to the following definitions:  
• 
Type A - Deviation to protect the life or physical well-being of a patient in an 
unforeseen emergency.  
• 
Type B - Deviation based on medical judgment.  
• 
Type C - Deviation due to misunderstanding of protocol requirements.  
• 
Type D - Deviation due to a situation that is beyond control.  
• 
Type E - Deviation due to an oversight, error or protocol non-compliance. 
16. Device/Equipment Accountability 
Device accountability is not required as this study does not utilize investigational devices. It 
will only recruit subjects who have been implanted with commercially approved devices. 

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17. Compliance 
17.1. Statement of Compliance 
This study will be conducted in accordance with ISO 14155, ethical principles that have their 
origins in the Declaration of Helsinki, and pertinent individual country laws and regulations. 
The study shall not begin until the required approval/favorable opinion from the IRB/EC 
and/or regulatory authority has been obtained, if appropriate. Any additional requirements 
imposed by the IRB/EC or regulatory authority shall be followed, if appropriate. 
17.2. Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing local 
and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and Protocol Signature 
page documenting his/her agreement to conduct the study in accordance with the 
protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event and observed device deficiency. 
• Report to BSC, per the protocol requirements, all serious adverse events (SAE) and 
device deficiencies that could have led to a serious adverse device effects (SADE). 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
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the IRB/EC, and supply BSC with any additional requested information related to the 
safety reporting of a particular event. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
monitor and respond to questions during monitoring visits. 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the ICF. 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the investigational device when it is used/operated by the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 

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17.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the investigator is responsible for providing appropriate 
training and adequate supervision of those to whom tasks are delegated. The investigator is 
accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of the clinical study.  
17.3. Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/EC is registered or that registration has been 
submitted to the appropriate agency, as applicable according to national/regulatory 
requirements.   
A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the study and shipment of investigational 
product/equipment. Prior approval must also be obtained for other materials related to subject 
recruitment or which will be provided to the subject. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements. Copies of the Investigator’s reports 
and the IRB/EC continuance of approval must be provided to the sponsor.  
17.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including Contract Research Organization (CRO) will have access to these 
confidential records. Authorized regulatory personnel have the right to inspect and copy all 
records pertinent to this study. Study data collected during this study may be used by BSC 
for the purposes of this study, publication, and to support future research and/or other 
business purposes. All data used in the analysis and reporting of this study will be without 
identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations.  Boston Scientific may use subjects’ health information to 
conduct this research, as well as for additional purposes, such as overseeing and improving 
the performance of its device, new medical research and proposals for developing new 
medical products or procedures, and other business purposes. Information received during 
the study will not be used to market to subjects; subject names will not be placed on any 
mailing lists or sold to anyone for marketing purposes.  

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17.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during testing required by the protocol. Support 
may include HCP training, addressing HCP questions, or providing clarifications to HCPs 
concerning the operation of BSC equipment/devices. 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment during follow-up, assist with the conduct of testing (e.g. impedance 
measurements) specified in the protocol, and interact with the subject to accomplish 
requested activities. Typical tasks may include the following. 
• Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating equipment 
• Performing lead diagnostic testing using a programmer to obtain thresholds and 
impedance measurements 
• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• Assisting with the collection of study data from programmers 
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the HCP 
• Independently collect critical study data (defined as primary or secondary endpoint data) 
17.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
18. Monitoring 
Monitoring may be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the monitor verifies that study records are 
adequately maintained, that data are reported in a satisfactory manner with respect to 
timeliness, adequacy, and accuracy, and that the Investigator continues to have sufficient 
staff and facilities to conduct the study safely and effectively. The Investigator/institution 

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guarantees direct access to original source documents by BSC personnel, their designees, and 
appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
19. Potential Risks and Benefits 
19.1. Risks Associated with Use of SCS device-programming as described in the protocol  
The anticipated adverse device effects (ADEs) known to be associated with SCS device 
programming as described in the study design are summarized below.   
 Note that the terms used to describe risk occurrence rates are defined as follows:  
• “Very Common” (occur in ≥50% of patients)  
• “Common” (occur in ≥20% to <50% of patients)  
• “Less Common” (occur in ≥5% to <20% of patients) 
• “Uncommon” (occur in ≥2% to <5% of patients) 
• “Rare” ( in <2% of patients)  
 
The estimated rates apply to typical use of SCS and likely overestimate risk occurrence given 
the brief time of the study intervention. 
 
19.1.1. Anticipated Adverse Device Effects Associated with SCS Device-stimulation 
Programming 
 
Common 
• Stimulation in non-target areas, which may include undesirable sensations of pain, 
pressure, numbness, or uncomfortable paresthesia 
• Undesirable sensations at target stimulation areas, which may include pain, pressure, 
numbness, or uncomfortable paresthesia  
 
Less Common 
• Inadequate stimulation resulting in increased pain, which may, for example, be due to 
a system malfunction, poor electrode positioning, or interference from other 
electromagnetic devices 
 
 
Uncommon 
• Overstimulation of tissue, which may produce sensations such as jolts or shocks, and 
potential injuries arising from secondary distraction or loss of muscle control, e.g. fall  

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Rare 
• Headache  
• Inability to change stimulation  
• Muscle spasms 
• Nausea 
• Nerve injury, which can result in symptoms such as unintentional tingling, numbness, 
pain, loss of bowel or bladder control, sexual dysfunction, weakness, or temporary or 
permanent paralysis  
• Seizure  
• Stimulation-related symptoms in other body systems, e.g. changes to urinary function, 
persistent penile erection 
 
19.1.2. Anticipated Adverse Events  
The following anticipated adverse events (AE) have been identified.  
• The subject may find it difficult, uncomfortable, or tiresome to complete study 
measurements and questionnaires. The rate of this occurring in study participants is 
unknown. 
19.2. Risks associated with Typical Use of SCS 
The risks summarized below are anticipated during use of SCS beyond the programming 
procedures, which are the primary focus of this study. The risks listed include those 
associated with the implant procedure, the presence of the SCS device system within the 
body, and the use of stimulation. (Potential risks not already identified may exist.) 
• Abnormal healing or failure to heal  
• Additional surgical procedure such as explant, revision, or reimplantation of the 
leads, extensions, or IPG, or revision of the IPG pocket  
• Allergic, immune, or inflammatory response or reaction to surgical materials or 
medication, or the presence of the device or its materials  
• Burns  
• Death  
• Deep vein thrombosis/thrombophlebitis  
• Depression due to unmet expectations of treatment  
• Discomfort, which can include minor tenderness, uncomfortable awareness of the 
device, or anxiety  
• Dural tear with or without cerebrospinal fluid leak  
• Electrical shock, e.g. from misuse of the charger base station plug-in to the wall outlet  
• Error during implantation of device, e.g. faulty connection of extension to IPG, which 
can lead to additional surgery  
• Headache  

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• Hematoma ranging from minor bruising to hematoma of a serious type e.g. an 
epidural hematoma resulting in paralysis  
• Hemorrhage requiring transfusion  
• Inability to change stimulation, e.g. the remote control stops working  
• Inadequate stimulation, which may be due to a system malfunction, poor electrode 
positioning, difficulty charging, or interference from other electromagnetic devices, 
e.g. MRI, cell phones, pacemakers, security screeners 
• Infection ranging from cellulitis or subcutaneous abscess to epidural abscess or sepsis 
• Muscle spasms 
• Musculoskeletal stiffness 
• Nausea 
• Nerve injury, which can result in symptoms such as unintentional tingling, numbness, 
pain, loss of bowel or bladder control, sexual dysfunction, weakness, or temporary or 
permanent paralysis  
• Overstimulation of tissue, which can include feeling sensations such as jolts or 
shocks, and potential injuries arising from this causing distraction or loss of muscle 
control, e.g. fall  
• Pain, including post-operative pain, pain at IPG site, or worsening of original pain 
• Pneumothorax, pneumocephalus, or injury to other tissues during surgery  
• Pulmonary embolism  
• Radiation exposure   
• Respiratory arrest, e.g. apnea spell during surgical procedure  
• Risks associated with any type of surgery, e.g. exposure to biohazardous materials  
• Seizure  
• Skin erosion over the device  
• Stimulation in non-target areas, which may include undesirable sensations of pain, 
pressure, numbness, or uncomfortable paresthesia 
• Stimulation-related symptoms in other body systems, e.g. changes to urinary function, 
persistent penile erection  
• Swelling, including seroma at the IPG site or other locations  
• Tissue damage at implant site from exposure to MRI  
• Undesirable sensations at target stimulation areas, which may include pain, pressure, 
numbness, or uncomfortable paresthesia  
• Weight gain or loss  
19.3. Risks Associated with the Study Device(s)  
The study device is commercially available and has no incremental risks beyond other 
similar market-available products. 
19.4. Risks associated with stopping the Therapy 
If the subject’s pain had improved during therapy, there is a risk that some or all of this 
improvement may be lost when the therapy is stopped. 

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19.5. Possible Interactions with Concomitant Medical Treatments 
19.5.1. Magnetic Resonance Imaging (MRI):  
The patient should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to this 
diagnostic technology may result in dislodgement of the Stimulator or lead(s), heating of the 
Stimulator, severe damage to the Stimulator electronics and/or increased voltage through the 
leads or Stimulator which can cause an uncomfortable or “jolting” sensation. 
19.5.2. Diathermy:  
SCS patients should not have any form of diathermy either as treatment for a medical 
condition or as part of a surgical procedure. The high energy and heat generated by 
diathermy can be transferred through the stimulator system, causing tissue damage at the lead 
site and, possibly, severe injury or death. The stimulator, whether it is turned on or off, may 
be damaged. 
19.5.3. Implanted Stimulation Devices:  
Spinal cord stimulators may interfere with the operation of implanted sensing stimulators 
such as pacemakers or cardioverter defibrillators. The effects of implanted stimulation 
devices on neurostimulators are unknown. 
19.5.4. Medical Devices/Therapies: 
The following medical therapies or procedures may turn stimulation off or may cause 
permanent damage to the Stimulator, particularly if used in close proximity to the device: 
• lithotripsy 
• electrocautery (See “Instructions for the Physician” in the Information for the Prescriber 
Manual) 
• external defibrillation 
• radiation therapy 
• ultrasonic scanning 
• high-output ultrasound 
If any of the above is required by medical necessity, refer to “Instructions for the Physician” 
the Information for the Prescriber Manual. Ultimately, however, the device may require 
explantation as a result of damage to the device. 
19.6. Risk Minimization Actions 
• 
Additional risks may exist. Risks can be minimized through compliance with this 
protocol, performing procedures in the appropriate environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent 
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19.7. Anticipated Benefits 
The reported benefit of SCS is to reduce chronic pain of the trunk and/or limbs.   
19.8. Risk to Benefit Rationale 
The risk evaluation for the BSC commercially approved SCS trial systems determined that 
all hazards attributed to the BSC commercially approved SCS trial systems and overall 
remaining residual risks after implementations of the required mitigations have been 
evaluated. Based on the risk evaluation results, the benefit provided by the BSC 
commercially approved SCS trial systems to treat chronic intractable pain of the trunk and 
limbs outweighs the remaining residual risk. As the overall residual risk meets BSN’s 
criteria, the BSC commercially approved SCS trial systems are acceptable for use in a 
clinical setting. 
20. Safety Reporting 
As the study does not utilize an investigational device, device deficiencies and medical 
complaints should be reported through the commercial complaint reporting process to the 
BSC Patient Care Center at (866) 360-4747, ext. 2 or BSN.ComplaintCallCenter@bsci.com. 
20.1. Definitions and Classification 
Examples of medical complaints that should be reported to the Boston Scientific 
Neuromodulation (BSN) Patient Care Center include adverse events.  Adverse event 
definitions are provided in Table 20.1. Administrative edits were made to combine 
definitions from ISO 14155-2011 and MEDDEV 2.7/3 12/2010. 
Table 20.1: Adverse Event Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the 
investigational medical device.  
NOTE 1: This includes events related to the medical device involved. 
NOTE 2: This definition includes events related to the procedures 
involved (any procedure in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the medical device involved.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event related to the use of an investigational medical device. 
NOTE 1: This definition includes any adverse event resulting from 
insufficient or inadequate instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device. 

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Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event that: 
• 
Led to death, 
• 
Led to  serious deterioration in the health of the subject, that either 
resulted in: 
o 
a life-threatening illness or injury, or 
o 
a permanent impairment of a body structure or a body 
function, or 
o 
in-patient  or prolonged hospitalization of existing 
hospitalization, or 
o 
medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function 
• 
Led to fetal distress, fetal death, or a congenital abnormality or 
birth defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, misuse or use errors, 
and inadequate labeling. 
 
 
 
Underlying diseases are not considered AEs unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be considered an AE, but 
should only be reflected as an outcome of a specific SAE (see Table 20.1 for AE definitions).  
Refer to Section 19 for the known risks associated with the study device(s). 
20.2. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 20.2-1. 
Table 20.2-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication 
Timeline  
Serious Adverse Event 
including Serious 
Adverse Device Effects 
Contact BSN Patient Care Center at 
(866) 360-4747, ext. 2 or 
BSN.ComplaintCallCenter@bsci.com 
• Within 2 business days 
of first becoming aware 
of the event or as per 

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Table 20.2-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication 
Timeline  
local/regional 
regulations. 
• Reporting through the 
end of the study 
Provide all relevant source 
documentation (unidentified) for 
reported event 
• When documentation is 
available 
Device Deficiencies 
(including but not 
limited to failures, 
malfunctions, and 
product 
nonconformities) 
Note:  Any Device 
Deficiency that might 
have led to a serious 
adverse event if a) 
suitable action had not 
been taken or b) 
intervention had not 
been made or c) if 
circumstances had been 
less fortunate is 
considered a reportable 
event. 
 
Contact BSN Patient Care Center at 
(866) 360-4747, ext. 2 or 
BSN.ComplaintCallCenter@bsci.com 
• Within 2 business days 
of first becoming aware 
of the event and as per 
local/regional 
regulations. 
• Reporting through the 
end of the study 
Adverse Event 
Contact BSN Patient Care Center at 
(866) 360-4747, ext. 2 or 
BSN.ComplaintCallCenter@bsci.com  
• Only device-related and 
procedure-related  AEs 
should be reported from 
enrollment through end 
of study participation 
• In a timely manner  (e.g. 
Recommend within 10 
business days) after 
becoming aware of the 
information 
• Reporting until the end 
of study participation 
Abbreviations: AE=adverse event 

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20.3. Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and labeling errors) should be documented and reported to BSN 
Patient Care Center. If possible, the device(s) should be returned to BSC for analysis. 
Instructions for returning the device(s) will be provided. If it is not possible to return the 
device, the investigator should document why the device was not returned and the final 
disposition of the device. Device failures and malfunctions should also be documented in the 
subject’s medical record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as medical complaints. However, if there is an 
adverse event that results from a device failure or malfunction, that specific event would be 
reported. 
And, any Device Deficiency that might have led to a serious adverse event if a) suitable 
action had not been taken or b) intervention had not been made or c) if circumstances had 
been less fortunate is considered a reportable event. 
20.4. Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information to all participating investigators 
and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory 
authorities of unanticipated adverse device effects (UADE) and SAE as required by 
local/regional regulations. 
  
21. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
all subjects or their legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to study-required procedures and/or testing, 
or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 
approved by BSC, the center’s IRB/EC, or central IRB, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative center’s IRB/EC.  Any modification requires approval from BSC prior to use of 
the form.  The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the center in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC approval prior to their use.  Privacy language shall be included in the 
body of the form or as a separate form as applicable.   

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The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. The original signed ICF will be retained by the center and a copy of the 
signed and dated document and any other written information must be given to the person 
signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Boston Scientific approval is required if changes to the revised ICF are 
requested by the center’s IRB/EC. The IRB/EC will determine the subject population to be 
re-consented. 
Study personnel should explain that even if a subject agrees to participate in the study and 
sign an Informed Consent form, additional screening may demonstrate that the subject is not 
a suitable candidate for the study. 
A Screening/Enrollment Log should be maintained to document select information about 
candidates who fail to meet the entry criteria. 

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22. Suspension or Termination 
22.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects.  Investigators, associated IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 
22.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
22.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
Any investigator, or IRB/ EC in the study may discontinue participation in the study or 
withdrawal approval of the study, respectively, with suitable written notice to Boston 
Scientific. Investigators, associated IRBs/ECs, and regulatory authorities, as applicable, will 
be notified in writing in the event of these occurrences. 
22.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific. 
The IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible. In the event there are no opportunities to transfer 
investigator responsibility; detailed information on how enrolled subjects will be managed 
thereafter will be provided by Boston Scientific. 
The investigator must return all documents and investigational product to Boston Scientific, 
unless this action would jeopardize the rights, safety, or welfare of the subjects. 

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22.4 Criteria for Suspending/Terminating a Study Center 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
center at any time after the study initiation visit if no subjects have been enrolled for a period 
beyond 6 months after center initiation, or if the center has multiple or severe protocol 
violations/noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of investigator participation, all study devices and testing 
equipment, as applicable, will be returned to BSC unless this action would jeopardize the 
rights, safety or well-being of the subjects. The IRB/EC and regulatory authorities, as 
applicable, will be notified. All subjects enrolled in the study at the center will continue to be 
followed. The Principal Investigator at the center must make provision for these follow-up 
visits unless BSC notifies the investigational center otherwise. 
23. Publication Policy 
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. BSC may submit study results for 
publication (regardless of study outcome) following the conclusion or termination of the 
study. Boston Scientific Corporation may adhere to the Contributorship Criteria set forth in 
the Uniform Requirements of the International Committee of Medical Journal Editors 
(ICMJE; http://www.icmje.org). In order to ensure the public disclosure of study results in a 
timely manner, while maintaining an unbiased presentation of study outcomes, BSC 
personnel may assist authors and investigators in publication preparation provided the 
following guidelines are followed. 
• All authorship and contributorship requirements as described above may be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
24. Reimbursement and Compensation for Subjects 
24.1. Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations.   
24.2. Compensation for Subject’s Health Injury 
Boston Scientific Corporation will purchase an insurance policy to cover the cost of potential 
health injury for study subjects, as required by applicable law.  

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25. Bibliography 
1. Breivik, H., Collett, B., Ventafridda, V., Cohen., R., and Gallacher, D.  Survey of 
chronic pain in Europe: Prevalence, impact on daily life, and treatment.  European 
Journal of Pain.  2006; 10(4):287-333. 
2. Carter, M.L., Spinal cord stimulation in chronic pain: a review of the evidence. Anaesth 
Intensive Care, 2004. 32(1): p. 11-21. 
3. Hasselströma, J., Liu-Palmgrenb, J., and Rasjö-Wrååkc, G. Prevalence of pain in general 
practice. European Journal of Pain. 2002;6(5):375-385. 
4. Kumar, K., G. Hunter, and D. Demeria, Spinal cord stimulation in treatment of chronic 
benign pain: challenges in treatment planning and present status, a 22-year experience. 
Neurosurgery, 2006. 58(3): p. 481-96; discussion 481-96. 
5. Kumar, K., et al., Spinal cord stimulation versus conventional medical management for 
neuropathic pain: a multicentre randomised controlled trial in patients with failed back 
surgery syndrome. Pain, 2007. 132(1-2): p. 179-88. 
6. Kumar, K., et al., The effects of spinal cord stimulation in neuropathic pain are 
sustained: a 24-month follow-up of the prospective randomized controlled multicenter 
trial of the effectiveness of spinal cord stimulation. Neurosurgery, 2008. 63(4): p. 762-
70; discussion 770. 
7. Manca, A., et al., Quality of life, resource consumption and costs of spinal cord 
stimulation versus conventional medical management in neuropathic pain patients with 
failed back surgery syndrome (PROCESS trial). Eur J Pain, 2008. 12(8): p. 1047-58. 
8. National Center for Health Statistics. Health, United States, 2010: With Special Feature 
on Death and Dying. Hyattsville, Maryland. 2011.Carter ML. Spinal cord stimulation in 
chronic pain: a review of the evidence. Anaesth Intensive Care. 2004;32: 11-21. 
9. North, R.B., Spinal cord stimulation for intractable pain: long-term follow-up. J Spinal 
Disord, 1990. 3(4): p. 356-61. 
10. North, R.B., et al., Spinal cord stimulation versus repeated lumbosacral spine surgery 
for chronic pain: a randomized, controlled trial. Neurosurgery, 2005. 56(1): p. 98-106; 
discussion 106-7. 
11. North, R.B., et al., Spinal cord stimulation versus reoperation for failed back surgery 
syndrome: a cost effectiveness and cost utility analysis based on a randomized, 
controlled trial. Neurosurgery, 2007. 61(2): p. 361-8; discussion 368-9. 
12. Oakley, J., Prager, JP, Stamatos, J, Foster AM, A new spinal cord stimulation system 
effectively relieves chronic, intractable pain:  a multicenter prospective clinical study. 
Neuromodulation, 2007. 10(3): p. 262-278. 
13. Taylor, R.S., et al., The cost effectiveness of spinal cord stimulation in the treatment of 
pain: a systematic review of the literature. J Pain Symptom Manage, 2004. 27(4): p. 
370-8. 

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14. Torrance, N., Smith, BH, and Lee, AJ.  The epidemiology of chronic pain of 
predominantly neuropathic origin. Results from a general population survey.  Journal of 
Pain.  2006; 7(4):281-9. 
 
 
 
26. Abbreviations and Definitions  
Abbreviations and definitions are shown in Table 24.2-1. 

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Table 24.2-1: Abbreviations and Definitions 
Abbreviation/Acronym/Term 
Term/Definition 
AE 
Adverse event: Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other 
persons, whether or not related to the investigational medical device. 
ADE 
Adverse device effects: AE related to the use of an investigational medical device 
BSC 
Boston Scientific Corporation 
BSN 
Boston Scientific Neuromodulation 
CA 
Competent Authority 
CE 
Clinical Exclusion Criteria 
CI 
Clinical Inclusion Criteria 
CP 
Clinician Programmer: laptop computer running BSC software used to program an external 
trial stimulator (ETS) or implantable pulse generator 
CMM 
Common medical management 
CRF 
Case Report Form 
DFU 
Directions for use 
DT 
Discomfort Threshold 
Enrollment 
A patient will be considered enrolled in the study at the point of providing written informed 
consent 
ETS 
External Trial Stimulator 
FDA 
Food and Drug Administration 
FBSS 
Failed Back Surgery Syndrome 
GCP 
Good Clinical Practices 
HCP 
Healthcare personnel 
ICF 
Patient Information and Informed Consent Form 
ICH 
International Conference on Harmonization 
ICMJE 
International committee of medical journal editors 
EC 
Ethics Committee 
IPG 
Implantable pulse generator 
IRB 
Institutional Review Board 
Lead 
Implantable device that delivers stimulation from an IPG or ETS to the target tissue (e.g. dorsal 
column stimulation leads in the dorsal epidural space).  For this study, only subjects with 
permanently implanted SCS surgical leads will be enrolled. 
MRI 
Magnetic resonance imaging 
PT 
Perception Threshold 
Programming 
The process of turning on and adjusting the stimulation parameters (amplitude, pulse width, 
rate, polarity) on an ETS or IPG. For this study, only subjects with an IPG will be enrolled. 
RCT 
Randomized Controlled Trial 
SCS 
Spinal Cord Stimulation 
SAE 
Serious adverse event: AE that led to death, serious deterioration in the health of the subject or 
led to fetal distress, death or congenital abnormality. 
SADE 
Serious adverse device effects: Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
UADE 
Unanticipated adverse device effects: Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects.