Spinal Cord Stimulation (SCS) Dosing Study
Phase: PHASE4
Conditions: Back Pain, Leg Pain
Sponsor: MedtronicNeuro

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Spinal Cord Stimulation (SCS) Dosing Study  
Clinical Investigation Plan Identifier MDT17046 
Study Product Name Medtronic RestoreSensor® (Models 97714 and 
37714) Implantable Neurostimulation Systems 
Sponsor Medtronic, Inc 
7000 Central Ave NE 
Minneapolis, Minnesota, 55432  
U.S.A. 
+1-763-514-4000 
Study Manager Sheryl McCammon 
Office: +1 (763) 526-8181 
Sheryl.mccammon@medtronic.com 
Medical Expert David Totoe 
Office: +1 (763) 526-4209 
David.a.totoe@medtronic.com 
Document Version Version 1.0, 22 Aug 2017 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 

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1. Investigator Statement 
Participating investigators will be provided with a separate investigator agreement to document their 
obligations and commitment with respect to study conduct. 
 
 

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Table of Contents  
 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
Table of Tables .......................................................................................................................... 6 
Table of Figures ......................................................................................................................... 7 
2. 
Glossary .............................................................................................................................. 8 
3. 
Synopsis ............................................................................................................................. 9 
4. 
Introduction ..................................................................................................................... 12 
4.1. Background ........................................................................................................................... 12 
4.2. Purpose ................................................................................................................................. 13 
5. 
Objectives and Endpoints ................................................................................................. 13 
5.1. Objectives ............................................................................................................................. 13 
5.1.1. 
Primary Objectives ................................................................................................................ 13 
5.1.2. 
Secondary Objectives ............................................................................................................ 13 
5.1.3. 
Additional Objectives ............................................................................................................ 13 
5.1.4. 
Safety Objectives ................................................................................................................... 14 
6. 
Study Design .................................................................................................................... 14 
6.1. Duration ................................................................................................................................ 14 
6.2. Rationale ............................................................................................................................... 14 
7. 
Product Description.......................................................................................................... 15 
7.1. General Product Description .................................................................................................... 15 
7.2. Product Return ...................................................................................................................... 16 
7.3. Product Accountability ............................................................................................................ 16 
8. 
Selection of Subjects ........................................................................................................ 16 
8.1. Study Population .................................................................................................................... 16 
8.2. Subject Enrollment ................................................................................................................. 17 
8.3. Inclusion Criteria (Screening Visit) ........................................................................................... 17 
8.4. Exclusion Criteria (Screening Visit) .......................................................................................... 17 
8.5. Baseline Eligibility Criteria ....................................................................................................... 17 
9. 
Study Procedures ............................................................................................................. 18 

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9.1. Schedule of Events ................................................................................................................. 18 
9.2. Subject Screening .................................................................................................................. 21 
9.3. Subject Consent ..................................................................................................................... 21 
9.4. Study Visit Procedures ............................................................................................................ 22 
9.4.1. 
Screening Visit ....................................................................................................................... 22 
9.4.2. 
Baseline/Programming Visit #1 ............................................................................................. 23 
9.4.3. 
Programming Visits #2, #3, and #4 ........................................................................................ 24 
9.4.4. 
Final Study Visit ..................................................................................................................... 25 
9.4.5. 
Telephone Reminders ........................................................................................................... 26 
9.4.6. 
Target Windows .................................................................................................................... 26 
9.5. Medications ........................................................................................................................... 27 
9.6. Assessment of Efficacy ........................................................................................................... 27 
9.6.1. 
Satisfaction and Stimulation Assessment (SSA) .................................................................... 27 
9.6.2. 
Visual Analog Scale (VAS) in Pain Diary ................................................................................. 27 
9.6.3. 
Oswestry Disability Index (ODI) ............................................................................................. 28 
9.6.4. 
European Quality of Life-5 Dimensions (EQ-5D) ................................................................... 28 
9.7. Assessment of Safety ............................................................................................................. 28 
9.8. Recording Data ...................................................................................................................... 29 
9.8.1. 
Programming Data ................................................................................................................ 29 
9.8.2. 
Imaging .................................................................................................................................. 29 
9.9. Deviation Handling ................................................................................................................. 30 
9.10. 
Subject Withdrawal or Discontinuation ............................................................................... 30 
10. 
Risks and Benefits ......................................................................................................... 31 
10.1. 
Potential Risks .................................................................................................................. 31 
10.1.1. Foreseeable Risks .................................................................................................................. 31 
10.1.1.1. 
Spinal Cord Stimulation Adverse Events Summary ........................................................ 31 
10.1.1.2. 
Device Deficiencies Risks ............................................................................................... 32 
10.1.1.3. 
Risks Associated with the Recharging System ............................................................... 33 
10.1.1.4. 
Radiographic Imaging..................................................................................................... 33 
10.1.1.5. 
Additional Risks and Information ................................................................................... 33 

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10.1.1.6. 
Mitigation of Risks.......................................................................................................... 33 
10.2. 
Potential Benefits ............................................................................................................. 34 
10.3. 
Risk-Benefit Rationale ....................................................................................................... 34 
11. 
Adverse Events and Device Deficiencies ....................................................................... 35 
11.1. 
Definitions ....................................................................................................................... 35 
11.2. 
Classifications .................................................................................................................. 36 
11.3. 
Recording of Adverse Events ............................................................................................. 37 
11.4. 
Recording of Device Deficiencies ....................................................................................... 37 
11.5. 
Reporting of Adverse Events and Device Deficiencies .......................................................... 37 
11.6. 
Emergency Contact Details ............................................................................................... 38 
11.7. 
Deaths ............................................................................................................................. 38 
12. 
Data Review Committees .............................................................................................. 38 
13. 
Statistical Design and Methods ..................................................................................... 38 
13.1. 
General Statistical Considerations ...................................................................................... 38 
13.1.1. Sample Size Justification ....................................................................................................... 39 
13.1.2. Investigation Site Pooling ...................................................................................................... 39 
13.1.3. Other Specific Considerations ............................................................................................... 39 
13.1.4. Reports .................................................................................................................................. 39 
13.2. 
Demographics .................................................................................................................. 39 
13.3. 
Primary Objective ............................................................................................................. 40 
13.3.1. Hypothesis ............................................................................................................................. 40 
13.3.2. Experimental Design ............................................................................................................. 40 
13.3.3. Analysis Methods and Presentation Format ......................................................................... 40 
13.3.4. Determination of Subject for Analysis .................................................................................. 40 
13.4. 
Secondary Objective ......................................................................................................... 40 
13.4.1. Hypothesis ............................................................................................................................. 40 
13.4.2. Experimental Design ............................................................................................................. 40 
13.4.3. Analysis Methods and Presentation Format ......................................................................... 41 
13.4.4. Determination of Subject for Analysis .................................................................................. 41 
13.5. 
Additional Objectives ........................................................................................................ 41 

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13.6. 
Safety Objective ............................................................................................................... 41 
13.7. 
Statistical Result Presentation ........................................................................................... 41 
14. 
Ethics ............................................................................................................................. 42 
14.1. 
Statements of Compliance ................................................................................................ 42 
15. 
Study Administration ..................................................................................................... 42 
15.1. 
Monitoring ....................................................................................................................... 42 
15.2. 
Medtronic Representative Role .......................................................................................... 42 
15.3. 
Data Management ............................................................................................................ 43 
15.4. 
Direct Access to Source Data/Documents ........................................................................... 44 
15.5. 
Confidentiality .................................................................................................................. 45 
15.6. 
Liability ............................................................................................................................ 45 
15.7. 
CIP Amendments ............................................................................................................. 45 
15.8. 
Required Reports and Records .......................................................................................... 45 
15.8.1. Investigator Records.............................................................................................................. 45 
15.8.2. Investigator Reports .............................................................................................................. 46 
15.9. 
Publication and Use of Information .................................................................................... 46 
15.10. 
Suspension or Early Termination ....................................................................................... 47 
16. 
References ..................................................................................................................... 48 
17. 
Appendices .................................................................................................................... 50 
18. 
Version History .............................................................................................................. 50 
 
Table of Tables 
Table 1. Medtronic Market-Released SCS Products ................................................................................... 15 
Table 2. Study Procedures, Tasks, and Data Collection by Visit ................................................................. 19 
Table 3: Perception Threshold Settings ...................................................................................................... 23 
Table 4: Final Perception Threshold Settings .............................................................................................. 26 
Table 5: Target Visit Windows .................................................................................................................... 26 
Table 6: Event Classification Responsibilities ............................................................................................. 36 
 

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Table of Figures 
Figure 1: Study Visit Diagram ...................................................................................................................... 20 
  
 

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2. Glossary 
Abbreviation 
Term 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CIP 
Clinical Investigation Plan  
CFR 
Code of Federal Regulations 
DD 
Device Deficiency 
eCRF 
Electronic Case Report Form 
EQ-5D 
European Quality of Life 5-Dimensions 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HCO 
Health Care Organization 
HCP 
Health Care Professional 
HD 
High Dose 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
INS 
Implantable Neurostimulation System 
IPG 
Implantable Pulse Generator 
IRB 
Institutional Review Board 
NPU 
Neuro Programmer Upload 
ODI 
Oswestry Disability Index 
RDC 
Remote Data Capture 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Events 
SCS 
Spinal Cord Stimulation 
SSA 
Satisfaction and Sensation Assessment 
USADE 
Unanticipated Serious Adverse Device Effect 
VAS 
Visual Analog Scale 
 
 

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3. Synopsis 
Title 
Spinal Cord Stimulation (SCS) Dosing Study  
Clinical Study Type 
Post-market feasibility 
Product Name 
Medtronic RestoreSensor® Neuromodulation Systems 
Sponsor  
Medtronic, Inc.  
7000 Central Ave NE 
Minneapolis, Minnesota, 55432  
U.S.A. 
+1-763-514-4000 
Indication Under 
Investigation  
Approved indication of spinal cord stimulation as an aid in the management of 
chronic, intractable pain of the trunk and limbs.   
Investigation 
Purpose 
To characterize the effects of amplitude titration on subject satisfaction and pain 
relief with high dose (HD) stimulation (90 µs and 1000 Hz) in subjects with back 
and leg pain being treated by SCS. 
Product Status 
All devices used in this study are commercially available and will be used within 
the intended approved indication.  
Primary 
Objective(s) 
To characterize the minimum amplitude as a percentage of perception threshold 
that maintains SCS therapy satisfaction. 
Secondary 
Objective(s) 
To characterize the minimum amplitude as a percentage of perception threshold 
that maintains overall pain relief.  
Additional 
Objectives 
1. To characterize the subject population who responded to HD stimulation, 
which is defined as having an average overall Visual Analog Scale (VAS) 
pain score ≤ 4 at baseline. The characterization will include: 
o Demographics 
o Therapy satisfaction and description, as measured by Satisfaction 
and Sensation Assessment (SSA) 
o Function, as measured by Oswestry Disability Index (ODI) 
o Quality of Life, as measured by European Quality of Life 5-
Dimensions (EQ-5D) 
2. To characterize the subject’s overall pain, back pain, and leg pain at 
baseline, as measured by VAS 
3. To characterize the amplitude of active therapy at baseline and the 
amplitude at perception thresholds collected in supine and sitting 
positions  
4. To characterize the locations of the active contacts 
Safety Objective 
To characterize therapy and device related adverse events and device deficiencies. 
Study Design 
This is a prospective, multi-center, single-blind post-market feasibility study.  This 
study will be conducted in the United States at no less than 2 sites.  To reduce the 
possibility of atypical results from a site overly influencing the combined results, 
no more than 30 subjects will be enrolled at each site.  Eligible subjects will 
receive four different programmed amplitude settings (80%, 60%, 40%, and 20% 

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of perception threshold), each for approximately two weeks. Subjects will be blind 
to the different amplitude settings and will not be informed that the amplitude is 
being titrated down, beginning at 80% of perception threshold. 
 
The overall study duration, from first subject enrollment to last subject visit, is 
expected to last approximately 15 months. Each subject’s participation in the 
study is expected to last approximately 12 weeks from enrollment. The 
completion of the study is defined as the approval of the Final Study Report and 
closure of all sites. 
Sample Size 
An estimated 60 subjects will be enrolled and screened for at least 40 subjects to 
proceed beyond the Baseline visit.  
 
A sample size of 40 subjects is reasonable to characterize the distribution of the 
minimum amplitude as a percentage of perception threshold that maintains SCS 
therapy satisfaction, as well as to provide data for consideration of future studies.  
Inclusion/Exclusion 
Criteria 
Screening Eligibility 
Inclusion Criteria: 
To be included in this study, a patient must meet the following inclusion criteria: 
1. 22 years of age or older 
2. Implanted with a RestoreSensor system (for back and leg pain) for at least 
1 month 
3. Has a program with only 1 anode and 1 cathode with 90 µs and 1000 Hz 
and the group that contains the program is used ≥ 50% (compared to the 
percent use of the other groups, if present) 
4. Willing and able to provide signed and dated informed consent 
5. Capable of comprehending and consenting in English 
6. Capable of getting into the supine and sitting positions for perception 
threshold testing 
7. Willing and able to comply with all study procedures and visits 
8. On stable (no change in dose, route, or frequency) prescribed pain 
medications for at least 4 weeks before enrollment and willing to maintain 
dose during the study 
 
Exclusion Criteria: 
To be included in this study, a patient must not meet any of the following 
exclusion criteria: 
1. Implanted with leads for peripheral nerve stimulation or an implantable 
intrathecal drug delivery system 
2. Had a pain-related surgery in the previous 1 months of enrollment or the 
intent to undergo surgery during the period of the study 
3. Implanted with quadripolar lead 
4. Currently enrolled or planning to enroll in a potentially confounding 
clinical study during the course of the study (co-enrollment in concurrent 

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studies is only allowed when documented pre-approval is obtained from 
the Medtronic study manager (or designee)) 
5. Pregnant or is of child-bearing potential and unwilling to use a medically 
acceptable form of birth control during the study 
6. Has untreated major psychiatric comorbidity, as determined by the 
investigator, or designee 
7. Has serious drug-related behavioral issues (e.g., alcohol dependency, 
substance abuse), as determined by the investigator, or designee 
8. Has unresolved major issues of secondary gain (ie, secondary reason not 
to report improvement in health condition), as determined by the 
investigator, or designee 
 
Baseline Eligibility 
To proceed on with the Baseline visit, the subject must meet the following 
inclusion criteria: 
1. Has an average overall VAS pain score ≤ 4 based on the Baseline diary  
To proceed on with the Baseline visit, the subject must not meet any of the 
following exclusion criteria: 
1. Has provided response to Baseline SSA as “Neutral”, “Somewhat 
unsatisfied”, or “Very unsatisfied” with the therapy 
2. Completed less than 5 of the 7 days of the Baseline diary 
Study Procedures 
and Assessments 
Subjects will complete a screening visit, baseline/programming visit, three 
additional programming visits, and a final study visit. Each subject is expected to 
complete 6 study-related visits.  
 
The following assessment measures will be used during the study:  
• 
Satisfaction and Sensation Assessment (SSA) 
• 
Oswestry Disability Index (ODI) 
• 
European Quality of Life 5-Dimensions (EQ-5D) 
• 
Visual Analog Scale (VAS) for pain within diary 
Safety Assessment 
Safety will be evaluated by the collection of device deficiencies and adverse 
events related to the following: 
• 
The implanted SCS system and accessories 
• 
Spinal cord stimulation therapy 
Statistics 
No hypothesis testing will be performed for the study.  
Descriptive statistics for the primary, secondary and additional objectives will be 
reported. 
Device and therapy related adverse events and device deficiencies will be 
presented in summary tables. 

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4. Introduction  
This on-label, post-market feasibility clinical study will be conducted with at least 2 sites. It is estimated 
that 60 subjects will be enrolled and screened for at least 40 to proceed beyond the Baseline visit.  The 
expected study commitment for each subject is intended to be approximately 12 weeks.  The study will 
be conducted in accordance with this protocol, the ethical principles that have their origin in the 
Declaration of Helsinki, all applicable regulatory requirements (21 Code of Federal Regulations (CFR) §11 
Electronic records; electronic signatures, 21 CFR §50 Protection of human subjects, 21 CFR§54 Financial 
disclosure by clinical investigators, 21 CFR §56 Institutional review boards, and 21 CFR §803 Medical 
device reporting), and will comply with Good Clinical Practices (GCP) as guidelines for this study. 
Documentation for this study will be produced and maintained to ensure that a complete history of the 
study exists.  Documents created for this study, including all versions of original documents, will be 
identifiable and appropriately stored to assure control and traceability of data related to this study. 
4.1. Background 
Spinal cord stimulation is an effective treatment for chronic, intractable pain of the trunk and/or limbs, 
including unilateral or bilateral pain associated with the following conditions: failed back surgery 
syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies 
resulting in pain secondary to FBS or herniated disk, postlaminectomy pain, multiple back operations, 
unsuccessful disk surgery, degenerative disk disease/herniated disk pain refractory to conservative and 
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive 
arachnoiditis, complex regional pain syndrome (CRPS), reflex sympathetic dystrophy (RSD), or causalgia.  
Spinal cord stimulation uses electrical pulses to activate or modulate the nervous system, resulting in 
pain relief. Stimulation parameters (amplitude, pulse width, frequency, electrodes) can be manipulated 
to provide patient-specific pain relief. Traditionally, parameters have been chosen to balance pain relief 
with comfortable paresthesia.  
In the last several years, clinical evidence has emerged to suggest that paresthesia may not be required 
for pain relief.1,2  Published studies have focused on two branded types of stimulation that seem to 
allow pain relief with either: 1) no paresthesia, as reported in studies on 10 kHz SCS, or HF10TM 
therapy1,2,3,4,5 or 2) minimal paresthesia, as reported in studies on burst SCS, BurstDR.6,7,8,9,10,11,12,13,14  The 
use of higher frequency stimulation of 1000 Hz with a pulse width of 90 µs has also been investigated for 
clinical outcomes as a consistent starting point for applying high dose (HD) stimulation.15  
Conventional SCS therapy has primarily been driven by selecting an amplitude that creates paresthesia 
coverage without causing discomfort. There is evidence that the T9/T10 intervertebral disc space has 
been a common location to target stimulation for chronic low back pain and leg pain using conventional 

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parameters for over 20 years.16,17,18,19  However, additional clinical work is needed to understand the 
effect of amplitude and electrode location when using HD stimulation. 
The ability to characterize the relationship between amplitude and HD stimulation may help improve 
future clinical practice by optimizing subject therapy for pain relief. Furthermore, if lower amplitude 
settings produce effective pain relief, the battery output of the neurostimulator could be reduced 
consequently decreasing the required recharge frequency. 
4.2. Purpose 
The purpose of this study is to characterize the effects of amplitude titration on subject satisfaction and 
pain relief with high dose (HD) stimulation (90 µs and 1000 Hz) in subjects with back and leg pain being 
treated by SCS.  
5. Objectives and Endpoints 
5.1. Objectives 
5.1.1. 
Primary Objectives 
To characterize the minimum amplitude as a percentage of perception threshold that maintains SCS 
therapy satisfaction. 
5.1.2. 
Secondary Objectives 
To characterize the minimum amplitude as a percentage of perception threshold that maintains overall 
pain relief. 
5.1.3. 
Additional Objectives 
• 
To characterize the subject population who responded to HD stimulation, which is defined as having 
an average overall VAS pain score ≤ 4 at baseline. The characterization will include: 
o Demographics 
o Therapy satisfaction and description, as measured by SSA 
o Function, as measured by ODI 
o Quality of Life, as measured by EQ-5D 
• 
To characterize the subject’s overall pain, back pain, and leg pain at baseline, as measured by VAS 
• 
To characterize the amplitude of active therapy at baseline and the amplitude at perception 
thresholds collected in supine and sitting positions 
• 
To characterize the locations of the active contacts 

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5.1.4. 
Safety Objectives 
To characterize therapy and device related adverse events and device deficiencies. 
6. Study Design  
This is a prospective, multi-center, single-blind post-market feasibility study.  This study will be 
conducted in the United States at no less than 2 sites.  To reduce the possibility of atypical results from a 
site overly influencing the combined results, no more than 30 subjects will be enrolled at each site.  
Eligible subjects will receive four different programmed amplitude settings (80%, 60%, 40%, and 20% of 
perception threshold), each for approximately two weeks. Subjects will be blind to the different 
amplitude settings and will not be informed that the amplitude is being titrated down, beginning at 80% 
of perception threshold. 
6.1. Duration 
It is estimated that 60 subjects will be enrolled and screened for at least 40 subjects to proceed beyond 
the Baseline visit. The enrollment period is expected to last about 1 year. Enrolled subjects will have up 
to 6 study visits (including Screening, Baseline/Programming Visit #1, Programming Visits #2-4, and the 
Final Study Visit.  Each of the four amplitude settings will be tested for approximately 2 weeks.  Subjects’ 
participation in the study is expected to last approximately 12 weeks from enrollment. The overall study 
duration, from first subject enrollment to last subject visit, is expected to last approximately 15 months. 
The completion of the study is defined as the approval of the Final Study Report and closure of all sites. 
6.2. Rationale 
The primary objective for this study is to characterize the minimum amplitude as a percentage of 
perception threshold that maintains SCS therapy satisfaction. The data collected will provide insight into 
the role of amplitude with HD settings and has the potential to shape future clinical practices of titrating 
amplitude to an effective dose. 
Furthermore, the study design builds on existing clinical evidence supporting the use of high dose 
stimulation delivered at 90 µs and 1000 Hz. 
With the increased use of high dose stimulation parameters, there is also an increase in battery exertion 
which potentially increases the frequency of recharging required by patients.20  Bench-top testing 
demonstrates that lowering the stimulation amplitude has an impact on reducing the battery drain for 
RestoreSensor® devices.21  If a subject achieves adequate satisfaction and/or pain control using lower 
amplitudes, the required recharge frequency could be reduced.  Limited literature is available regarding 
the minimum amplitude level needed to produce effective SCS therapy when stimulating at a high dose 
(90 µs and 1000 Hz). 

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Based upon the limited data in the literature, this study was designed as a feasibility study focused on 
characterization rather than specific hypothesis testing. For this reason, a simpler longitudinal study 
design was favored over a cross over clinical study. The outcomes of this study may be used as the basis 
for future clinical studies.  
The use of a longitudinal study design with decremental dose is intended to characterize a trend in the 
amplitude dose relationship for HD stimulation. The titration of amplitude by 20% decrements applied 
over bi-weekly periods, and the assessment of each setting at the end of each period is intended to try 
and minimize any carryover effects.  
7. Product Description 
7.1. General Product Description 
Subjects who have previously been implanted with a RestoreSensor implantable neurostimulator (INS), 
Model 97714 or 37714, system will be enrolled in this study. The implanted system consists of an INS, 
one or more leads, and applicable compatible extensions, anchors and accessories. Non-implanted 
system components include the clinician programmer and software application card, a patient 
programmer, an INS recharging system, and applicable accessories.  
Table 1 contains the allowed model numbers of the key implanted components (leads and 
neurostimulators) of the neuromodulation system.  
Table 1. Medtronic Market-Released SCS Products 
Model Numbers 
Name 
Neurostimulators 
97714 
RestoreSensor® SureScan® MRI Rechargeable neurostimulator  
37714 
RestoreSensor® neurostimulator 
Leads 
977A1 
Vectris™ SureScan® MRI Subcompact 
977A2 
Vectris™ SureScan® MRI 1x8 Compact 
3776 
Pisces Octad Subcompact 
3777 
Pisces Octad Standard 
3778 
Pisces Octad Compact 
977C1 
Specify SureScan MRI 5-6-5 
977C2 
Specify SureScan MRI 2x8 
39565 
Specify 5-6-5 
39286 
Specify 2x8 

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7.2. Product Return 
All products are commercially available and no products will be provided as a part of this study. Subjects 
are to be implanted with their SCS system prior to enrollment. Subjects who require a system 
modification or explant will be exited prior to the procedure. Explanted devices should be returned 
through normal commercial methods. 
7.3. Product Accountability  
No product accountability will be required for the study. 
Subjects who participate in the study beyond the Baseline visit will need to surrender their patient 
programmer to site personnel for the duration of the study.  If the subject does not bring their patient 
programmer to the Baseline visit, the commencement of the first treatment period (80% perception 
threshold) will need to be postponed until the subject is able to bring their patient programmer to the 
site.  
Site personnel will store each subject’s patient programmer in a secure location. Each subject will be 
given back their patient programmer at the end of their participation in the study. 
8. Selection of Subjects 
8.1. Study Population 
A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) 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 conditions:  
• 
Failed Back Syndrome (FBS) or low back syndrome or failed back 
• 
Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk 
• 
Postlaminectomy pain 
• 
Multiple back operations 
• 
Unsuccessful disk surgery 
• 
Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical 
interventions 
• 
Peripheral causalgia 
• 
Epidural fibrosis 
• 
Arachnoiditis or lumbar adhesive arachnoiditis 
• 
Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia 
 
This study will enroll a sub-set of the population indicated for SCS systems. Subjects who meet the 
eligibility criteria listed in Sections 8.3-8.4 are eligible to be enrolled in the study. 

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8.2. Subject Enrollment 
Subjects are considered enrolled at the time the study-specific Informed Consent Form (ICF) is signed.  
Each subject must meet all the inclusion criteria and no exclusion criteria to be eligible to participate in 
this study. 
8.3. Inclusion Criteria (Screening Visit) 
To be included in this study, a patient must meet the following inclusion criteria: 
1. 22 years of age or older 
2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month 
3. Has a program with only 1 anode and 1 cathode with 90 µs and 1000 Hz and the group that 
contains the program is used ≥ 50% (compared to the percent use of the other groups, if 
present).  
4. Willing and able to provide signed and dated informed consent 
5. Capable of comprehending and consenting in English 
6. Capable of getting into the supine and sitting positions for perception threshold testing 
7. Willing and able to comply with all study procedures and visits 
8. On stable (no change in dose, route, or frequency) prescribed pain medications for at least 4 
weeks before enrollment and willing to maintain dose during the study 
8.4. Exclusion Criteria (Screening Visit) 
To be included in this study, a patient must not meet any of the following exclusion criteria: 
1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug 
delivery system 
2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo 
surgery during the period of the study 
3. Implanted with quadripolar lead 
4. Currently enrolled or planning to enroll in a potentially confounding clinical study during the 
course of the study (co-enrollment in concurrent studies is only allowed when documented pre-
approval is obtained from the Medtronic study manager (or designee)) 
5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of 
birth control during the study 
6. Has untreated major psychiatric comorbidity, as determined by the investigator, or designee 
7. Has serious drug-related behavioral issues (e.g., alcohol dependency, substance abuse), as 
determined by the investigator, or designee 
8. Has unresolved major issues of secondary gain (ie, secondary reason not to report improvement 
in health condition), as determined by the investigator, or designee  
8.5. Baseline Eligibility Criteria 
To proceed on with the Baseline visit, the subject must meet the following inclusion criteria: 
1. Has an average overall VAS pain score ≤ 4 based on the Baseline diary 

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To proceed on with the Baseline visit, the subject must not meet any of the following exclusion criteria: 
1. Has provided response to Baseline SSA as “Neutral”, “Somewhat unsatisfied”, or “Very 
unsatisfied” with the therapy 
2. Completed less than 5 of the 7 days of the Baseline diary 
9. Study Procedures  
9.1. Schedule of Events 
Table 2 reflects the study procedures, tasks, and data collection by each visit and Figure 1 is a study visit 
diagram. Subjects will be required to come into the clinic for the following 6 study visits:  
• 
Screening 
• 
Baseline /Programming Visit #1 
• 
Programming Visit #2 
• 
Programming Visit #3  
• 
Programming Visit #4 
• 
Final Study Visit 
 
A telephone call will be placed to the subjects one week before each clinic visit to remind them to begin 
completing the diary. 

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Table 2. Study Procedures, Tasks, and Data Collection by Visit 
Study Procedures, 
Tasks, and Data 
Collection (row) by 
Visit (column) 
Screening 
Baseline/ 
Programming 
#1 
Programming 
#2 
Programming 
#3 
Programming 
#4 
Final 
Study 
Visit 
Informed Consent 
√ 
 
 
 
 
 
Screening Eligibility 
√ 
 
 
 
 
 
Demographics 
√ 
 
 
 
 
 
Medical/Surgical 
History 
√ 
 
 
 
 
 
Pain Medications 
√ 
 
 
 
 
 
Device Information 
√ 
 
 
 
 
 
Baseline Eligibility 
 
√ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect Patient 
Programmer 
 
√ 
 
 
 
 
Imaging  
 
√* 
 
 
 
 
Perception 
Thresholds  
 
√ 
 
 
 
√ 
Telephone Call** 
 
√ 
√ 
√ 
√ 
√ 
Pain Diary 
(distribute) 
√ 
(Baseline) 
√ 
(80%) 
√ 
(60%) 
√ 
(40%) 
√ 
(20%) 
 
Pain Diary (collect 
completed) 
 
√ 
(Baseline) 
√ 
(80%) 
√ 
(60%) 
√ 
(40%) 
√ 
(20%) 
Device 
Interrogation 
Programming & 
Upload (initial and 
final) 
√ 
√ 
√ 
√ 
√ 
√ 
SSA 
 
√ 
√ 
√ 
√ 
√ 
AE/DD 
√ 
√ 
√ 
√ 
√ 
√ 
Lead Identification 
 
 
 
 
 
√*** 
Return Patient 
Programmer 
 
 
 
 
 
√ 
* On the day of the Baseline visit, or during the study, subjects must have imaging performed. 
** A telephone call will be placed to the subjects one week before they return to the clinic to remind them to begin completing 
the diary. 
*** Will only be performed with subjects who have two leads implanted; may take place at a separate visit. 

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Figure 1: Study Visit Diagram 
Screening
Screening
Eligibility
Discontinuation
No
Baseline
Yes
Telephone Reminder
Baseline
Eligibility
Discontinuation
No
Programming (80%)
Yes
Programming (60%)
Telephone Reminder
Programming (40%)
Telephone Reminder
Programming (20%)
Telephone Reminder
Final
Telephone Reminder
 
 
 

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9.2. Subject Screening  
Subjects may be recruited through the investigator’s practice and referring physicians.  It is 
recommended to recruit subjects who live within a reasonable distance from the site. 
Potential subjects may be identified through chart reviews or as new or existing patients attend clinic 
visits.  If subjects are recruited from outside the investigator’s practice, sites are to ensure that 
appropriate release for access to the subject’s records (paper and/or electronic) is obtained. Any subject 
recruitment materials disseminated to subjects (advertisements, handouts, posters, social media) must 
be approved by the Institutional Review Board (IRB) prior to use.  
Recruited subjects will be screened by the principal investigator or authorized site personnel by 
reviewing the study’s inclusion and exclusion criteria.  All subjects must be consented in accordance with 
the protocol, and IRB requirements, prior to any study-specific procedures.  Subjects who do not meet 
any of the inclusion or who meet exclusion criteria may not be rescreened. 
9.3. Subject Consent 
The informed consent process will be performed in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki and with 21CFR§50 Protection of Human Subjects. 
Prior to entering the study, the principal investigator or qualified designee will explain to each subject 
the purpose and nature of the study, procedures, expected study duration, available alternative 
therapies, and the benefits and risks involved with study participation and the potential treatment.  
Subjects will be given a copy of the IRB-approved ICF/Health Insurance and Portability and 
Accountability Act (HIPAA) form and any other written information.  In addition, subjects will be given 
adequate time to review the document and to ask questions and will be informed of their right to 
withdraw from the study at any time without prejudice. Subjects must be able to read and comprehend 
the ICF written in English.  After this explanation and review period, and before any study-specific 
procedures have been performed, the subject will voluntarily sign and date the ICF/HIPAA form.  The 
date the subject signs the ICF/HIPAA form represents the date the subject is considered enrolled in the 
study; subjects are considered enrolled in the study upon signing the ICF/HIPAA.  
The principal investigator, or appropriately delegated personnel, will document the informed consent 
process, including the date of consent and name of the person conducting the consent process in the 
subject’s medical record.  The original signed ICF/HIPAA should also be placed in the subject’s medical 
record. Subjects must complete the informed consent process prior to any study-related procedures or 
testing being conducted. If the informed consent process is obtained the same day the subject begins 
participating in study-related procedures, it should be clearly documented in the subject’s case history 
that consent was obtained prior to participation in any study-related procedures. 

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A template informed consent will be provided by Medtronic under separate cover.  Any changes to the 
ICF template must be approved by Medtronic and the reviewing IRB prior to initiation of subject 
enrollment or for any changes during the study. 
Any new information developed during the study which might affect the subject’s understanding of the 
informed consent or the study, or the subject’s decision to continue to participate, will be brought to 
the subject’s attention by the principal investigator or site staff. 
9.4. Study Visit Procedures 
Subjects will be assessed for eligibility to the study-specific inclusion/exclusion criteria through the 
Baseline visit. 
9.4.1. 
Screening Visit 
The Screening visit will commence after each subject has been enrolled. Subjects who do not meet all 
eligibility criteria will be exited from the study.   
During the Screening visit the following will be collected: 
• 
Subject demographics 
• 
Medical and surgical history 
• 
Device information 
• 
Pain medication usage  
 
Each subject’s device will be interrogated and a report session will be generated to capture the subject’s 
initial active therapy settings. 
Eligibility criteria will be evaluated to ensure subjects have a program with only 1 anode and 1 cathode 
with 90 µs and 1000 Hz and the group that contains the program is used ≥ 50%. Any additional programs 
and groups within each subject’s device will be removed during this visit. 
Each subject’s device will be set to the program with only 1 anode and 1 cathode with 90 µs and 1000 
Hz, being used upon entry into the study, for a Baseline period lasting at least 2 weeks. 
A report session will be generated to capture the subject’s final active therapy settings. 
Subjects will be provided with a multi-day diary and asked to record their VAS pain scores for the last 7 
days of the Baseline period.  A telephone call will be placed to the subjects one week before they return 
to the clinic to remind them to begin completing the diary.  Subjects should bring their completed diary 
with them to the Baseline visit. 

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9.4.2. 
Baseline/Programming Visit #1 
The Baseline/Programming Visit #1 will be targeted to take place at least 2 weeks after the Screening 
visit.  At the beginning of the Baseline visit, subjects will return their completed diary, complete the 
Subject Satisfaction Assessment (SSA), and baseline eligibility criteria will be assessed.  
To proceed on with the Baseline visit, the subject must meet the following inclusion criteria: 
1. Has an average overall VAS pain score ≤ 4 based on the Baseline diary 
To proceed on with the Baseline visit, the subject must not meet any of the following exclusion criteria: 
1. Has provided response to Baseline SSA as “Neutral”, “Somewhat unsatisfied”, or “Very 
unsatisfied” with the therapy 
2. Completed less than 5 of the 7 days of the Baseline diary 
 
Subjects who do not meet Baseline eligibility criteria will be exited from the study and will be considered 
a screen failure.  
Subjects who meet the Baseline eligibility criteria will continue with the study and complete the 
following assessments: 
• 
Oswestry Disability Index (ODI) 
• 
European Quality of Life-5 Dimensions (EQ-5D) 
 
On the day of the Baseline visit, or during the course of the study, subjects must have imaging 
performed (eg, fluoroscopy or x-ray), which will be annotated with a vertebral marker.  
 
Each subject’s device will be interrogated and a report session will be generated to capture the subject’s 
initial active therapy settings. 
The perception threshold and description of the sensation will be collected for Setting 1 (90 µs and 1000 
Hz) with subjects in both the supine and sitting positions. Furthermore, the perception threshold will 
also be collected for one or more of the other 3 settings in Table 3 (eg, if time permits and the subject is 
not in too much discomfort) with subjects in both the supine and sitting positions, beginning with the 
supine position for all settings and in the order listed. 
Table 3: Perception Threshold Settings 
 
Pulse Width 
Frequency 
Setting 1 
90 µs 
1000 Hz 
Setting 2 
120 µs 
1000 Hz 
Setting 3 
450 µs 
50 Hz 
Setting 4 
150 µs 
1200 Hz 
 

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Each subject’s device will be programmed with four groups at 90 µs and 1000 Hz. The active anode and 
cathode in each group will remain the same as what the subject used during the Baseline period and 
should remain the same for the duration of the study. The only difference between the four groups will 
be the amplitude, which will be set to 80%, 60%, 40%, and 20% of the determined amplitude perception 
thresholds in the sitting and supine positions with AdaptiveStimTM enabled. If subjects are unable to 
reach a perception threshold at 90 µs and 1000 Hz, the maximum amplitude allowed by the device (9.9 
volts) will be used as the perception threshold. 
Subjects will begin their first treatment period programmed to the group with 80% perception threshold 
and AdaptiveStimTM enabled. 
At the conclusion of programming, a report session will be generated to capture the subject’s final 
active therapy settings. 
Subjects will be asked to give their patient programmer to site personnel for the remaining duration of 
the study. If the subject does not bring their patient programmer to the Baseline visit, the 
commencement of the first treatment period (80% perception threshold) will need to be postponed 
until the subject is able to bring their patient programmer to the site. Once a subject exits the study, 
their patient programmer will be returned. Subjects will be informed, although they will not have access 
to their patient programmer during the study, they can turn their device off using their recharger.  
During the study, patients may need to recharge their device more or less often and should check their 
device daily to verify whether recharging is needed. 
Subjects will be provided a diary to record their VAS pain scores for the last week of the follow-up 
period prior to coming back into the clinic. A telephone call will be placed to the subjects one week 
before they return to the clinic to remind them to begin completing the diary. 
9.4.3. 
Programming Visits #2, #3, and #4 
Beginning approximately two weeks after the Baseline visit, in accordance with the targeted windows in 
Section 9.4.6, subjects will return to the clinic for Programming Visit #2 and should bring back their 
completed diary.  After Programming Visit #2, subjects will return to the clinic about every two weeks 
for Programming Visits #3 and #4. 
 
During Programming Visits #2, #3, and #4, subjects will be asked to complete the SSA to reflect their 
satisfaction of the last therapy setting. Subjects will also record on the SSA whether they have felt any 
stimulation sensations during the last follow-up period and, if so, to describe the sensation.  
 
Each subject’s device will be interrogated and a report session will be generated to capture the subject’s 
initial active therapy settings. 

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With the device programmed to 90µs and 1000 Hz, the amplitude will be programmed based on the 
perception thresholds obtained in the supine and sitting positions during the Baseline visit as follows: 
• 
Programming Visit #2: 60% of Baseline perception threshold  
• 
Programming Visit #3: 40% of Baseline perception threshold  
• 
Programming Visit #4: 20% of Baseline perception threshold  
 
If subjects are unable to reach a perception threshold at 90 µs and 1000 Hz, the maximum amplitude 
allowed by the device (9.9 volts) will be used as the perception threshold. 
At the conclusion of programming, a report session will be generated to capture the subject’s final 
active therapy settings. 
Subjects will be provided a diary to record their VAS pain scores for the last week of each follow-up 
period. Subjects should bring back their completed diary each time they return to the clinic at the end of 
a follow-up period. A telephone call will be placed to the subjects one week before they return to the 
clinic to remind them to begin completing the diary. 
9.4.4. 
Final Study Visit  
During the Final Study visit, subjects will be asked to complete the Satisfaction and Sensation 
Assessment (SSA).  
Each subject’s device will be interrogated and a report session will be generated to capture the subject’s 
initial active therapy settings. 
The perception threshold and description of the sensation will be collected for Setting 1 (90 µs and 1000 
Hz) with subjects in both the supine and sitting positions. Furthermore, the perception threshold will 
also be collected for one or more of the other 6 settings in Table 4 (eg, if time permits and the subject is 
not in too much discomfort) with subjects in both the supine and sitting positions, beginning with the 
supine position for all settings and in the order listed. 

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Table 4: Final Perception Threshold Settings 
 
Pulse Width 
Frequency 
Setting 1 
90 µs 
1000 Hz 
Setting 2 
120 µs 
1000 Hz 
Setting 3 
450 µs 
50 Hz 
Setting 4 
150 µs 
1200 Hz 
Setting 5 
500 µs 
500 Hz 
Setting 6 
1000 µs 
200 Hz 
Setting 7 
1000 µs 
100 Hz 
 
 
At the end of the visit, subjects will have their patient programmers returned to them and be 
programmed to a setting per standard of care.  
 
Prior to exiting the study, subjects who are implanted with two leads will have at least 4 different 
electrode combinations activated and, for each electrode combination, be asked to complete 
paresthesia maps.  The highest electrode on each lead will be annotated on the image taken during the 
Baseline visit, and or described on the eCRF, to reflect which one is electrode 0 and which is electrode 8.  
If needed, this may take place as a separate visit. Site personnel will de-identify each image and send 
them to Medtronic. 
9.4.5. 
Telephone Reminders 
One week prior to each programming visit, subjects will be called and reminded to begin completing the 
pain diary. Subjects should also be reminded to bring back their completed diary at each visit.  
9.4.6. 
Target Windows 
The following visit windows, Table 5, should be targeted when scheduling study visits.  If a subject is 
unable to return within the target visit window, a protocol deviation will not be required if the minimum 
3 days of diary data are captured sometime after the first week of the period. 
Table 5: Target Visit Windows 
Visit 
Target Windows 
Baseline/Programming Visit 1 
At least 2 weeks + 7 days of Screening visit 
Programming Visit 2 
Within 2 weeks +/- 3 days Programming Visit 1 
Programming Visit 3 
Within 2 weeks +/- 3 days Programming Visit 2 
Programming Visit 4 
Within 2 weeks +/- 3 days Programming Visit 3 
Final Study Visit 
Within 2 weeks +/- 3 days Programming Visit 4 

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9.5. Medications 
All medications prescribed for the treatment of pain will be collected during the Screening visit. Only 
subjects who are on stable (no change in dose, route, or frequency) prescribed pain medications for at 
least 4 weeks prior to screening and willing to maintain the dose during the study are eligible for 
participation. Any prescribed changes to a subject’s pain medications while they are enrolled in the 
study will be collected. 
9.6. Assessment of Efficacy 
9.6.1. 
Satisfaction and Stimulation Assessment (SSA) 
Subjects will be asked to indicate their satisfaction with the therapy and details pertaining to any 
stimulation sensations. The SSA will include questions such as the following: 
• 
Overall how satisfied or unsatisfied are you with this therapy? 
o Very satisfied 
o Somewhat satisfied 
o Neutral 
o Somewhat unsatisfied 
o Very unsatisfied 
• 
Specify reason for this response? 
 
• 
Have you felt any stimulation sensations? 
o No 
o Yes, specify the following: 
▪ 
Occasional or Continuous 
▪ 
Pleasant or Unpleasant 
▪ 
Position when felt (lying on back, lying on front, lying on right, lying on left, mobile, 
reclining, upright, other) 
9.6.2. 
Visual Analog Scale (VAS) in Pain Diary 
Pain will be assessed using the VAS in a pain diary. The VAS is a 10 cm line, with “No pain” on left and 
“Worst pain imaginable” on the right.  
Subjects will record their overall, back, and leg pain using a paper pain diary once a day for a 7-day 
period prior to the scheduled study visits. For the initial baseline pain diary, completed prior to the 
baseline visit, subjects are required to complete at least 5 of the 7 days to ensure diary compliance 
during the study.  
For the scheduled follow-up visits, the subject will be reminded to complete the diary for a 7-day period 
prior to the scheduled follow-up visit and the last 3 days of the diary will be used for the assessment. 
The pain diary questionnaire will consist of questions such as the following: 

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• 
Please rate your pain by making a vertical slash mark through the line that best describes your 
average overall pain during the last 24 hours. (Line with “No pain” on left and “Worst pain 
imaginable” on the right)  
• 
Please rate your pain by making a vertical slash mark through the line that best describes your 
average back pain during the last 24 hours. (Line with “No pain” on left and “Worst pain 
imaginable” on the right)  
• 
Please rate your pain by making a vertical slash mark through the line that best describes your 
average leg pain during the last 24 hours. (Line with “No pain” on left and “Worst pain 
imaginable” on the right)  
9.6.3. 
Oswestry Disability Index (ODI) 
The ODI (version 2) is one of the most highly recommended measures for patients with spinal 
disorders.22,23 The validated questionnaire consists of 10 subject-reported sections on the ability to 
perform activities of daily living. A raw ODI score will be calculated from the total score of 10 sections.  
This ODI raw score will be normalized to a scale of 0 to 100, with 0 to 20 categorized as minimal 
disability, 20 to 40 as moderate disability, 40 to 60 as severe disability, and more than 60 as severely 
disabled in several areas of life. 
9.6.4. 
European Quality of Life-5 Dimensions (EQ-5D)  
The European Quality of Life – Five Dimensions (EQ-5D), version 5L, is a standardized measure of health 
status developed by the EuroQol Group 24 and a widely used validated tool to determine health-related 
quality of life.  The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual 
activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity: no 
problems, slight problems, moderate problems, severe problems, extreme problems. The subject will be 
asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 
dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. 
The digits for 5 dimensions can be combined into a 5-digit number describing the respondent’s health 
state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as 
a cardinal score. 
The EQ Visual Analog Scale (VAS) records the respondent’s self-rated health on a vertical, visual 
analogue scale where the endpoints are labeled ‘Best imaginable health state’ and ‘Worst imaginable 
health state.’ This information can be used as a quantitative measure of health outcome as judged by 
the individual respondents. 
9.7. Assessment of Safety 
Safety will be evaluated by the collection of device deficiencies and adverse events related to the 
following: 

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• 
The implanted SCS system and accessories 
• 
Spinal cord stimulation therapy 
9.8. Recording Data 
This study will use a remote data capture (RDC) system to collect study required Case Report Form (CRF) 
information.  Electronic CRFs (eCRFs) will be provided by the sponsor; required data will be taken from 
source documents and directly entered into the study database via the eCRFs by the appropriately 
delegated site personnel, in accordance with applicable regulations.  Source documentation for pain 
diaries and subject assessments will be captured in a paper format and completed confidentially by the 
subject only.  Data from the paper assessments will be entered into the database by authorized site 
personnel.   
Representatives from the clinical site may not make changes to the diaries except for administrative 
entries.  
The principal investigator, or appropriately delegated personnel, are responsible for entering data on 
the eCRFs.  The principal investigator, or appropriately delegated personnel, is required to approve all 
data on eCRFs via electronic signature. 
9.8.1. 
Programming Data 
Through device interrogations with the 8840 N’Vision® Clinician Programmer, parameter data (eg, 
session data files) will be collected from the neurostimulator. 
Report Link is a commercially available tool, which will be used during this study that allows clinicians to 
electronically transfer and save session data files as a PDF document from the 8840 N’Vision® Clinician 
Programmer to the computer. Those PDF files can be printed to local or network printers and stored into 
electronic medical record systems, and uploaded into the Neuro Programmer Upload (NPU) application. 
The NPU is an application designed to capture programmer interrogation output reports (eg, “session 
data reports”) from the 8840 N’Vision Clinician Programmer and store them within a Medtronic 
database for analysis and reporting. 
9.8.2. 
Imaging 
Images (eg, fluoroscopy or x-ray) performed during the study will be annotated with a vertebral marker.  
For subjects with more than one lead, the highest electrode on each lead will be annotated, and or 
described on the eCRF, to reflect which one is electrode 0 and which is electrode 8.  
Site personnel will de-identify each image prior to securely sending them to Medtronic.  

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After receipt by Medtronic, the images will be evaluated by a qualified reader to define and characterize 
the locations of the active contacts.  Medtronic will keep all copies of the images that they receive in a 
secure location and may use them for other business purposes outside of this study. 
9.9. Deviation Handling 
A deviation is defined as an instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the clinical investigation plan (CIP). The investigator is not allowed to deviate from the 
CIP, except under emergency circumstances to protect the rights, safety and well-being of human 
subjects.  
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, 
or makes a conscious decision to deviate. If the deviation affects subject’s rights, safety and well-being, 
or the scientific integrity of the study, prior approval from IRB is also required. Prior approval is not 
required when a deviation is necessary to protect the safety, rights or well-being of a subject in an 
emergency or in unforeseen situations beyond the investigator’s control (e.g. subject failure to attend 
scheduled follow-up visits, inadvertent loss of data due to computer malfunction, inability to perform 
required procedures due to subject illness). 
All study deviations must be reported on the eCRFs regardless of whether medically justifiable, pre-
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency.  
Study deviations must be reported to Medtronic as soon as possible upon the site becoming aware of 
the deviation. Reporting of deviations must comply with IRB policies, local laws, and/or regulatory 
agency requirements.  
Medtronic is responsible for reviewing deviations, assessing the effectiveness of the CIP, confirming 
appropriate deviation reporting requirements are met, identifying site trends that require action. 
Repetitive or serious investigator compliance issues may result in initiation of a corrective action plan 
with the investigator and site, and in some cases, necessitate suspending enrollment until the problem is 
resolved or ultimately terminating the investigator's participation in the study. 
9.10. Subject Withdrawal or Discontinuation 
A subject has the right to withdraw from the study at any time and for any reason without prejudice to 
their future medical care by the principal investigator or institution.  Subjects will be provided standard 
medical care by their physician after their study participation ends. 
The study sample size accounts for expected attrition, thus exited subjects will not be replaced. 
Examples of reasons for study exit include the following: 

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• 
Subject death 
• 
Subject lost to follow-up 
• 
Subject voluntarily withdraws from the study 
• 
Subject becomes pregnant 
• 
Investigator terminates the subject’s participation in the study due to lack of compliance, violation 
of/change in eligibility criteria 
• 
Any clinical laboratory abnormality, inter-current illness, or other medical condition or situation 
occurs such that continued study participation would not be in the best interest of the subject 
• 
Normal study completion 
 
A study exit eCRF will be completed for all enrolled subjects; the reason for withdrawal shall be recorded 
on the study exit eCRF. If a subject exits from the study prior to normal completion, the eCRFs for visits 
that have occurred up to the point of withdrawal as well as the study exit eCRF should be completed.  If 
a subject exits due to an adverse event or device deficiency, the appropriate event eCRFs should also be 
completed. 
 
If the subject proceeds beyond the Baseline/Programming Visit #1 but chooses to withdraw from the 
study early; if they are willing, the Final Study Visit procedures may be completed prior to study exit. 
 
If a subject requires a system modification or replacement during the study, they should be exited from 
the study. 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded in the subject’s medical records. In addition, regulations set forth by the governing IRB 
must be followed. 
10. Risks and Benefits 
10.1. Potential Risks 
This is a post-market study and subjects will be treated in accordance with the labeled instructions for 
use and indications for Medtronic’s SCS therapy.  There are foreseeable risks that exist for all SCS 
patients regardless of whether they are in the study.  There are no expected new or increased risks 
associated with this clinical study. 
10.1.1. 
Foreseeable Risks 
10.1.1.1. Spinal Cord Stimulation Adverse Events Summary 
The implantation of a spinal cord stimulation system involves risks that are similar to other spinal 
procedures. In addition to those normally associated with surgery, implantation or use of a 

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neurostimulation system includes, but is not limited to, the following risks: 
• 
Allergic or immune system response to the implanted materials 
• 
Infection 
• 
Lead, extension, or neurostimulator erosion through the skin or migration 
• 
Leakage of cerebrospinal fluid 
• 
Loss of pain relief may return patients to their underlying pain condition 
• 
Patients on anticoagulation therapies may be at greater risk for postoperative complications 
such as hematomas that can result in paralysis 
• 
Persistent pain at the neurostimulator site 
• 
Placement of the epidural lead-extension is a surgical procedure that may expose patients to 
risks of epidural hemorrhage, hematoma, or paralysis 
• 
Radicular chest wall stimulation 
• 
Seroma or hematoma at the neurostimulator site 
• 
Stimulation-dependent gastrointestinal symptoms such as diarrhea, incontinence or 
constipation 
• 
Stimulation-dependent bladder symptoms such as urinary retention, incontinence or frequency 
• 
Change in stimulation, possibly related to cellular changes around the electrode(s), shifts in 
electrode position, loose electrical connections, lead or extension fractures, which has been 
described by some patients as uncomfortable stimulation (jolting or shocking sensation). 
• 
Formation of reactive tissue around the lead in the epidural space can result in delayed spinal 
cord compression and paralysis, requiring surgical intervention. Time to onset can range from 
weeks to many years after implant. 
• 
The safety and effectiveness of this therapy has not been established for pregnancy, unborn 
fetus, or delivery. The study procedures may involve unknown risks for female subjects, their 
embryo or fetus (unborn child), or delivery if they become pregnant. For this reason, pregnant 
females have been excluded from participating in this study.  Female subjects must agree to not 
become pregnant during the study by using a medically acceptable method of birth control; an 
identified pregnancy will result in immediate study withdrawal. 
10.1.1.2. Device Deficiencies Risks 
The use of SCS systems includes risk of the following device deficiencies: 
• 
Mechanical failure/damage of system components, eg, premature battery depletion, lead 
fracture (increased impedance), or breach of insulation 
• 
Migration or dislodgement of the lead(s) 
• 
Migration, dislodgement, or flipping of the neurostimulator 
• 
Programming and/or telemetry problems that might limit the capability to program or 
determine what parameters are programmed 
• 
Potential coupling or telemetry problems during recharging may cause inconsistency or limit 
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• 
Over-discharge of the neurostimulator battery may shorten battery life, permanently damage 
the battery, and/or result in the need for a replacement 
• 
Premature battery depletion resulting in the need for a replacement 
10.1.1.3. Risks Associated with the Recharging System 
• 
The recharger, antenna, belt and holster are not sterile, and contact with the wound could 
cause an infection. The recharger is not intended to be used on an unhealed wound. 
• 
Use of rechargeable neurostimulation systems may be associated with adverse events including 
heating sensation, discomfort, blistering not caused by heating, skin irritation, or redness near 
the implanted neurostimulator during or after recharging. Patients should check for skin 
irritation or redness near the neurostimulator during or after recharging. 
10.1.1.4. Radiographic Imaging 
As part of the study, subjects will be required to have fluoroscopic or X-ray images taken of their 
thoracic spine.  This may be beyond what is standard of care.  The risk associated with these additional 
images has been considered and determined to be minimal. 
10.1.1.5. Additional Risks and Information 
Additional information including precautions, warnings, and contraindications is included within the 
packaged labeling of each system component. 
Parameters used during the study may not be effective.  Additionally, because the amplitude level will 
be titrated down, some subjects may not receive effective therapy after a certain threshold is reached, 
which could result in an increase level of pain. Furthermore, prescribed pain medications should remain 
stable (no change in dose, route, or frequency) during the study. 
Depending on the programmed parameters the subject was using when they entered the study, it is 
possible subjects may need to recharge more frequently during one or more treatment periods. 
There may be additional risks related to this study, other than the ones described, that are not yet 
known. 
10.1.1.6. Mitigation of Risks 
At any time during the study, subjects will be able to turn their device OFF using their Patient Recharger. 
Furthermore, a subject has the right to withdraw from the study at any time and for any reason (eg, due 
to insufficient pain relief). 

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10.2. Potential Benefits 
There may be no direct benefit from participation in the study. The SCS settings used during this study 
may reduce subjects’ pain intensity, return subjects to a more fully functional status, and/or improve 
their quality of life.  Additionally, with stimulation delivered at sub-perception threshold amplitudes, 
subjects may avoid uncomfortable or even intolerable stimulation sensations, such as painful 
paresthesia. During the study subjects will have increased interaction with physicians or medical staff 
compared to routine clinical care, which may provide some indirect health benefits.  Another possible 
benefit for participating in this study may be a reduction in the number of required recharging sessions 
for individual subjects.   
Data from this study may have the anticipated benefit of helping Medtronic with the understanding of 
SCS therapy and assisting with the design of future studies and product improvements.  The information 
gathered from this study could also help clinicians optimize therapy for their patients. 
10.3. Risk-Benefit Rationale 
Neurostimulation therapies, such as SCS, are used as an aid in the management of chronic, intractable 
pain that cannot be effectively managed with medications and/or other conservative treatments alone. 
Patients considered for neurostimulation therapy have typically had pain of long duration and have 
failed multiple therapeutic paths.  
Medtronic has carefully designed and tested the RestoreSensor® Neurostimulation Systems for the 
approved indications. Medtronic has completed an extensive risk analysis to ensure the identification of 
potential hazards and subsequent mitigation of these hazards to eliminate them entirely or reduce them 
to an acceptable level.  With existing PMA approval for the commercially available RestoreSensor® 
Neurostimulation Systems, an established safety profile of probable benefit outweighing risk already 
exists for SCS Therapy for chronic low back and/or leg pain. In most cases SCS is a reversible procedure 
that can be turned off or removed. Moreover, stimulation parameters are adjustable to minimize or 
reverse complications and maximize therapeutic effects.  
The study investigates the relationship between amplitude dose, therapy satisfaction, and pain relief in 
subjects being actively treated with SCS using HD parameters (90 µs and 1000 Hz).  The system output 
and programming parameters used with the SCS Dosing study are within the approved ranges of the 
commercially available RestoreSensor® Neurostimulation Systems. The anticipated benefits of the 
clinical outcomes of SCS therapy per the study design outweigh the overall risk. 

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11. Adverse Events and Device Deficiencies 
11.1. Definitions 
Adverse Event (AE): (ISO 14155:2011 3.2) 
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 
investigational medical device.  
NOTE 1: This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
Adverse Device Effect (ADE): (ISO 14155:2011 3.1) 
Adverse event related to the use of an investigational medical device. 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or 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. 
Serious Adverse Event (SAE): (ISO 14155:2011 3.37) 
Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function,  
c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
Serious Adverse Device Effect (SADE): (ISO 14155:2011 3.36) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
Unanticipated Serious Adverse Device Effect (USADE): (ISO 14155:2011 3.42) 
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. 

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NOTE: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
Device Deficiency (DD): (ISO 14155:2011 3.15) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. 
NOTE: Device deficiencies include malfunctions, use errors, and inadequate labeling. 
Malfunction: (ISO 14155:2011 3.27) 
Failure of an investigational medical device to perform in accordance with its intended purpose when 
used in accordance with the instructions for use or CIP. 
Use Error: (ISO 14155:2011 3.43) 
Act or omission of an act that results in a different medical device response than intended by the 
manufacturer or expected by the user. 
NOTE 1: Use error includes slips, lapses, and mistakes. 
NOTE 2: An unexpected physiological response of the subject does not in itself constitute a use 
error. 
11.2. Classifications 
Each adverse event is classified according to ISO 14155:2011. Where the definition indicates “device”, it 
refers to any device used in the study. This might be the device under investigation, or any market 
released component of the system. 
 
All reportable adverse events will be classified using the responsibility matrix in Table 6.  
Table 6: Event Classification Responsibilities 
What is Classified 
Who Classifies 
Classification Parameters 
Relatedness 
Investigator 
Therapy related 
Device related 
Seriousness 
Investigator 
SAE/SADE 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and 
other supporting data 
Medtronic 
MedDRA term assigned based on the data 
provided by investigator 
 

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11.3. Recording of Adverse Events 
Adverse Event (AE) information will be collected from the time the subject has been enrolled until they 
are discontinued from the study. AE information will be reported to Medtronic on an adverse event 
eCRF, one for each Adverse Event.  
Only those AEs which are related to the following will be collected: 
• 
The implanted SCS system and accessories 
• 
Spinal cord stimulation therapy 
 
It is the responsibility of the investigator to identify the occurrence of adverse events and device 
deficiencies and to ensure all required information is accurately documented on the eCRF. See the eCRFs 
for the information to be reported for each adverse event.  
Documented pre-existing conditions are not considered adverse events unless the severity of the 
condition has worsened and is related to the implanted SCS system, accessories, or therapy. 
For adverse events that require immediate reporting, initial reporting may be done by phone, fax, or e-
mail, or on the eCRF by completing as much information as is available. The adverse event eCRF must be 
completed as soon as possible. 
In case the investigator requires information from the sponsor in an emergency, the investigator can 
contact the Medtronic study team using the contact details provided in Section 11.6. 
The clinical course of each adverse event must be followed until the adverse event is resolved or the 
subject is in a stable condition. “Ongoing” adverse events must be assessed at each study visit. The 
adverse event eCRF should to be updated when there is a change to the information provided on the 
form (e.g. change in intervention, outcome, relatedness, etc.). 
11.4. Recording of Device Deficiencies 
Device deficiencies are events associated with a medical device that do not result in an adverse event 
for the subject. Device deficiency information will be collected throughout the study and reported to 
Medtronic on a device event eCRF, one for each device deficiency.  
11.5. Reporting of Adverse Events and Device Deficiencies 
It is the responsibility of the Investigator to abide by the adverse event reporting requirements and to 
also follow the reporting requirements of the IRB. Unanticipated Serious Adverse Device Effects 
(USADE), must be reported to Medtronic within 24 hours of the effect, and to the IRB as required. 

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11.6. Emergency Contact Details 
In case of an emergency or to immediately report an Adverse Event, the investigators can contact the 
study team using the following email address: rs.scsdosing@medtronic.com. 
11.7. Deaths 
The investigator must notify Medtronic immediately and the IRB, as required, after learning of a 
subject’s death, regardless of whether or not the death is related to the device system or therapy.  The 
investigator should also attempt to determine, as conclusively as possible, whether such deaths are 
related to the device system or therapy. If the death is evaluated as device-related or therapy-related, 
and unanticipated, the event will be reported as an USADE by Medtronic to the FDA. Deaths will be 
captured by a study exit eCRF and an adverse event eCRF if related to the device system or therapy. 
If an autopsy is conducted, a copy of the report should be provided to Medtronic.  Medtronic requests 
that all device system components that were being used at the time of the death be returned to 
Medtronic for analysis per Section 7.2.  Requested death certificates and/or source documentation 
should be provided to Medtronic.  If the death occurs at a location remote from the study site, it is the 
study site’s responsibility to make every attempt to retrieve all pertinent information related to the 
subject’s death and submit the investigator’s death summary of the known events surrounding the 
death to Medtronic. 
12. Data Review Committees  
This study will not use a Clinical Events Committee or Data Monitoring Committee. Instead, all reported 
adverse events and device deficiencies will be reviewed by a Medtronic Medical Advisor to ensure 
consistent reporting. Regular meetings will be held by Medtronic personnel, including the Medical 
Advisor, to review adverse events and identify potential trends in safety data during the clinical study. 
13. Statistical Design and Methods 
13.1. General Statistical Considerations  
Data analysis will be performed by Medtronic-employed statisticians or designees. A validated statistical 
software package will be used for the analyses of the study results (e.g., SAS). 
The Statistical Analysis Plan (SAP) will be developed prior to data analysis and will include a 
comprehensive description of the statistical methods and reports to be included in the final study 
report. Any change to the data analysis methods described in the CIP will require an amendment only if 
it changes a principal feature of the CIP. Any other change to the data analysis methods described in the 
CIP, and the justification for making the change, will be described in the clinical study report.   

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13.1.1. 
Sample Size Justification 
An estimated 60 subjects will be enrolled in order for at least 40 subjects to proceed beyond the 
Baseline visit. A sample size of 40 subjects is reasonable to characterize the distribution of the minimum 
amplitude as a percentage of perception threshold that maintains SCS therapy satisfaction, as well as to 
provide data for consideration of future studies.  
13.1.2. 
Investigation Site Pooling 
The investigators of this study will conduct the study according to a common protocol and use the same 
CRFs to collect study data. The site study personnel will be trained prior to the study initiation at each 
site. Periodic study monitoring by Medtronic will ensure compliance with protocol requirements.  
There is no a priori provision to exclude any sites from the analysis. The data from all sites will be pooled 
for analysis. To reduce the possibility of atypical results from a site overly influencing the combined 
results, no more than 30 subjects will be enrolled at each site. 
13.1.3. 
Other Specific Considerations 
Adjustment for Baseline Covariates 
There is no plan to make adjustment for baseline covariates for the primary objective.  
Handling Missing Data 
Missing data are a potential source of bias when analyzing study data. A rigorous study design and 
execution will help prevent the incidence of missing data from occurring.  
The analysis of the primary and secondary objectives will use subjects who provide data.  
Adjustment for Multiple Endpoints 
As there is no hypothesis testing, adjustment for multiple endpoints is not required.  
Interim Analysis 
There is no planned interim analysis for the primary and secondary objectives in this study. 
13.1.4. 
Reports 
Statistical analysis summaries will be included in the clinical report. Any deviations from this section or 
from the SAP will be described and justified in the clinical report. 
13.2. Demographics 
Demographics and baseline characteristics will be summarized in the report for all subjects who 
complete the Baseline visit and meet the Baseline eligibility requirements. 

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13.3.  Primary Objective 
To characterize the minimum amplitude as a percentage of perception threshold that maintains SCS 
therapy satisfaction. 
13.3.1. 
Hypothesis 
There is no hypothesis testing for the primary objective. The purpose of the primary objective is to 
characterize the minimum amplitude that maintains SCS therapy satisfaction.  
13.3.2. 
Experimental Design 
The measurement of SSA is described in Section 9.6.1. Subject dissatisfaction with the therapy is defined 
as subjects choosing either ‘somewhat unsatisfied’ or ‘very unsatisfied’. The SSA is collected at baseline 
and scheduled follow-up visits. 
13.3.3. 
Analysis Methods and Presentation Format 
The frequency and percentage of subjects satisfied with the therapy will be summarized at baseline and 
scheduled follow-up visits. The percentage of amplitude from perception threshold for maintaining 
subjects’ satisfaction with the therapy will be summarized too.  
13.3.4. 
Determination of Subject for Analysis 
Subjects who provide data will be included in the analysis.  
13.4. Secondary Objective 
To characterize the minimum amplitude as a percentage from perception threshold that maintains 
overall pain relief. Maintaining overall pain relief is defined as having ≤ 2 points increase in average 
overall pain VAS during study follow-up. 
13.4.1. 
Hypothesis 
There is no hypothesis testing for the secondary objective. The purpose of the secondary objective is to 
characterize the minimum amplitude that maintains overall pain relief of equal or less than 2 points 
increase in average overall VAS pain scores.  
13.4.2. 
Experimental Design 
The measurement of pain score is described in Section 9.6.2. For baseline, an average overall VAS pain 
score is calculated using all 7 days of the diary. For scheduled follow-up visits, an average overall VAS 
pain score is calculated using the last 3 days of the diary prior to the scheduled visit, to ensure that there 

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is no residual treatment effect from the previous period. The pain scores are collected at baseline and 
scheduled follow-up visits. 
13.4.3. 
Analysis Methods and Presentation Format 
The mean and standard deviation of the pain score will be summarized at each follow-up visit. The 
percentage of amplitude from perception threshold for maintaining overall pain relief will be 
summarized.  
13.4.4. 
Determination of Subject for Analysis 
Subjects who provide data will be included in the analysis.  
13.5. Additional Objectives 
• 
To characterize the subject population who responded to HD stimulation, which is defined as 
having an average overall pain VAS ≤ 4 at baseline. The characterization will include: 
o Demographics 
o Therapy satisfaction and description, as measured by SSA 
o Function, as measured by ODI 
o Quality of Life, as measured by EQ-5D 
• 
To characterize the subject’s overall pain, back pain, and leg pain at baseline, as measured by 
VAS 
• 
To characterize the amplitude of active therapy at baseline and the amplitude at perception 
thresholds in supine and sitting positions 
• 
To characterize the locations of the active contacts 
13.6. Safety Objective 
To characterize therapy and device related adverse events and device deficiencies. 
13.7. Statistical Result Presentation 
Statistical results will be presented in the reports according to the standard clinical study report 
template. 

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14. Ethics 
14.1. Statements of Compliance  
The study will be conducted in accordance with this protocol, the ethical principles that have their origin 
in the Declaration of Helsinki, all applicable regulatory requirements (21CFR§50 Protection of Human 
Subjects, 21CFR§56 IRB, and 21CFR§54 Financial Disclosure of Clinical Investigators, and 21CFR§803 
Medical Device Reporting) and will comply with Good Clinical Practices (GCP) as a guideline for this 
study.  The principles of the Declaration of Helsinki have been implemented in this study by means of 
the patient informed consent process, IRB approval, risk benefit assessment, study training, clinical trial 
registration on http://clinicaltrials.gov/, and publication policy.  Study Investigators will be required to 
sign an Investigator Agreement stating their intent to adhere to applicable regulations. 
The study will not begin at any site until an IRB letter approving the protocol, the ICF, and any other 
subject-facing documents is received by Medtronic.   
Details related to stipends provided to study subjects are outlined in the subject ICF.  
15. Study Administration 
15.1. Monitoring 
Medtronic is responsible to the regulatory agencies for ensuring the proper conduct of this study in 
terms of adherence to applicable regulations, protocol compliance, and the validity and accuracy of the 
study data entered on eCRFs.  Medtronic will assign Medtronic personnel, or designee, as monitors to 
aid in ensuring study staff understanding of the applicable regulations, and to assess and ensure 
principal investigator and study staff’s understanding of the protocol, reporting requirements, and data 
validity.  The principal investigator and study staff will provide the Medtronic monitors with complete 
and direct access to primary source data (eg, paper and electronic hospital/clinical charts, appointment 
books, laboratory records) that support the data on the eCRFs as well as other documentation 
supporting the conduct of the study.  Monitors will perform source data verification and routine reviews 
of study-related regulatory documents during scheduled monitoring visits and work to secure 
compliance should any deficiencies be observed.  
15.2. Medtronic Representative Role 
Medtronic representatives who are qualified and trained on the protocol and applicable study 
regulations may participate in the conduct of the study under the direct supervision of the principal 
investigator as described below.  The principal investigator, or delegated personnel, must be present to 
collect source documentation, record the study activities, and to be responsive to the subject’s needs 
during an activity performed by a Medtronic representative. 

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Medtronic personnel may perform the following: 
• 
Provide technical support during follow-up visits 
• 
Perform device programming, device interrogation, device download while under the direction 
of the investigator 
• 
Discuss any issues with programming or subject compliance with the principal investigator or 
site personnel 
Medtronic personnel may not perform the following: 
• 
Practice medicine, provide medical diagnoses or make decisions related to subject 
treatment/care 
• 
Express opinions about the product under study 
• 
Assist the subject by direct physical contact except as required by the specific protocol-related 
task to be conducted 
• 
Discuss a subject’s condition or medical treatment with the subject or a member of the subject’s 
family 
• 
Provide the subject with any form/questionnaires related to the products under investigation 
• 
Enter data on eCRFs, except for administrative Medtronic use only forms 
15.3. Data Management 
This study will use the Oracle Clinical Remote Data Capture (RDC) system, which allows the study centers 
to enter data directly to the eCRF in the sponsor’s database over a secure internet connection. This 
system controls user access, ensures data integrity, and maintains audit trails. It is a fully validated 
system. 
The principal investigator will ensure that only appropriately delegated study personnel are given access 
to the electronic eCRF system; user IDs and passwords may not be shared. 
The principal investigator is responsible for the overall quality (completeness and accuracy) of the data 
entered on the eCRFs and in all other required reports.  Data reported on the eCRFs, must be derived 
from and consistent with source documents, unless otherwise stated in this section or the study 
monitoring plan. If discrepancies in source are identified (eg, during monitoring), these need to be 
corrected or justified in a documented rationale, signed and dated by the principal investigator, or 
authorized delegate, to be maintained as a part of the subject’s records.  The principal investigator will 
review all data entries on a regular basis and ensure any corrections are appropriately made and 
documented.  
The eCRF may be considered source for the following data collection elements: 
• 
Investigator assessment of adverse event relatedness 
• 
Detail pertaining to and reason for protocol deviation 

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Even when the eCRF may be considered as source, an alternative method of source documentation is 
always strongly encouraged.  
Required data will be recorded on the appropriate eCRFs at the time of or promptly after each subject’s 
visit. Only authorized persons can complete eCRFs. eCRFs will be approved by the principal investigator, 
or authorized delegate with an electronic signature.  
Medtronic personnel will perform routine edit and consistency checks, in-house and during monitoring 
visits, for items such as missing data or inconsistent data.  Identified data inconsistencies will be 
resolved by use of data queries; investigators and site personnel will review data queries and respond to 
them in a timely manner. The resolved discrepancy will become a part of the eCRF record for the 
subject. At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
User access to the RDC system will be granted to each individual based on his or her delegation of 
authority. If a person only authorized to complete eCRFs makes changes to an already signed eCRF, the 
system will require the investigator, or authorized delegate, to re-sign the eCRF. 
15.4. Direct Access to Source Data/Documents  
Source data are defined as all information in original records, certified copies of original records of 
clinical findings, observations, or other activities in a clinical investigation necessary for the 
reconstruction and evaluation of the clinical investigation. A source document is a printed, optical, or 
electrical document containing source data. Examples of source documents include the following: 
hospital records, laboratory notes, device accountability records, photographic negatives, radiographs, 
records kept at the investigational site, and at laboratories involved in the clinical investigation. 
The principal investigator is responsible for ensuring source data and documents are complete, legible 
and accurate; and entries are made in a timely manner by appropriately delegated study staff.  
The principal investigator and site personnel will provide the Medtronic monitor(s) with direct access to 
source data that support the data on the CRFs as well as other documentation supporting the conduct of 
the study.   
Medtronic or third-party auditors representing Medtronic may perform Quality Assurance audits to 
verify the performance of the monitoring process and study conduct, and to ensure compliance with 
applicable regulations. Representatives for regulatory bodies, such as the FDA, may also perform site 
inspections related to this clinical study.  The principal investigator, site personnel, and institution will 
provide auditors with direct access to primary source data and all study-related documentation.  
Medtronic will investigate suspected cases of fraud or misconduct as appropriate. 

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15.5. Confidentiality  
All records and other information about subjects participating in this clinical study will be treated as 
confidential. Subject confidentiality will be maintained throughout the clinical study to the extent 
permitted by law. That is, every attempt will be made to remove subject identifiers from clinical study 
documents. For this purpose, a unique subject identification code (study - site - subject number) will be 
assigned and used to allow identification of all data reported for each subject. This will also ensure that 
the information can be tracked back to the source data.  
Study data may be made available to third parties, e.g., in the case of an audit or inspection performed 
by regulatory authorities, provided the data are treated confidentially and that the subject’s privacy is 
guaranteed. The identity of a subject will never be disclosed if study data are published. Only 
anonymized data will be analyzed and published. 
15.6. Liability 
Medtronic, Inc. is a wholly owned subsidiary of Medtronic, PLC, which as the parent company of such 
entity maintains appropriate clinical study liability insurance coverage, as applicable and as required 
under applicable laws and regulations and will comply with applicable local law and custom concerning 
specific insurance coverage. If required, a clinical study insurance statement/certificate will be provided 
to the IRB. In addition, subject compensation, indemnification, and insurance may be addressed within a 
separate clinical trial agreement. 
15.7. CIP Amendments 
Amendments to the CIP may be initiated by Medtronic to address changes to the conduct of the study.   
Amendments to the CIP, and associated documents, must be approved by Medtronic and submitted to 
the IRBs for approval prior to implementation except when necessary to eliminate an immediate or 
apparent immediate hazard to participating subjects. 
15.8. Required Reports and Records 
15.8.1. 
Investigator Records 
Documentation for this study will be produced and maintained to ensure that a complete history of the 
study exists.  Documents created for this study, including all versions of original documents, will be 
identifiable and appropriately stored to assure control and traceability of data related to this study. 
The principal investigator is responsible for the ensuring that all essential study documentation is 
retained and accessible for 2 years (or longer as local law or hospital administration requires) after the 

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investigation is terminated or completed.  The retention period may be longer if required by Medtronic 
or regulatory requirements. Medtronic will be responsible for notifying sites of extensions to the 2-year 
minimum record retention requirements.  The principal investigator will ensure that essential study 
documents are not destroyed until written permission has been obtained from Medtronic.  Medtronic 
will be notified in writing of any transfer of study documentation. 
15.8.2. 
Investigator Reports 
The principal investigator is responsible for the preparation (review and signature) and submission to 
the sponsor of all case report forms, reportable adverse events, device deficiencies, deaths, and any 
deviations from the CIP. If any action is taken by an IRB with respect to this clinical study, copies of all 
pertinent documentation must be forwarded to Medtronic in a timely manner. Reports are subject to 
inspection and to the retention requirements as described in Section 15.8.1 for investigator records.  
15.9. Publication and Use of Information 
Medtronic may publish the results from the SCS Dosing Study. Publication activities may include 
abstracts, presentations/posters to scientific meetings, and manuscripts. 
Investigators who gathered data for this study (i.e., enrolled subjects and complied with the protocol) 
may be asked to write or contribute to the writing of abstracts and manuscripts based on the results of 
this study. Investigators will be considered for abstract/manuscript authorship if they meet the 
International Committee of Medical Journal Editors, Ethical Considerations in the Conduct and Reporting 
of Research criteria available via the following link: http://www.icmje.org. Specifically, authorship credit 
should be based on the following and should meet all criteria listed below:   
• 
Substantial contributions to conception or design; or the acquisition, analysis and interpretation 
of data for the work;  
• 
Drafting the article or revising it critically for important intellectual content; and  
• 
Final approval of the version to be published; and 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
Medtronic employees who meet the International Committee of Medical Journal Editors criteria for 
authorship will have the right to authorship. 
All contributors who do not meet the criteria for authorship are to be listed in an acknowledgments 
section according to the guidelines of the applicable scientific journal. Examples of those who might be 
acknowledged include a person who provided purely technical help, writing assistance, or a department 
chair that provided only general support. 
Before publication of any study-related data, the following will apply: 

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• 
Any publication based on the results obtained from a single site (or a group of sites) shall not be 
made before the first multi-center publication.   
• 
If a publication concerns the analyses of sub-sets of data from a multi-center publication, the 
publication shall refer to the relevant multi-center publication(s). 
• 
Investigators will provide Medtronic with an opportunity to review and comment on any 
publication developed from data derived from this study at least sixty (60) days prior to 
submission for publication, public dissemination, or review by a publication committee. 
• 
Investigators agree that all reasonable comments made by Medtronic in relation to a proposed 
publication will be incorporated by the Investigator into the publication. 
Medtronic will not financially compensate health care professionals (HCPs) or health care organizations 
(HCOs) for writing or editing activities on scientific publications related to research sponsored by 
Medtronic. 
If required by a publisher, the principal investigator agrees to obtain all necessary authorizations from 
study subjects prior to submitting study-related information for publication. 
15.10. 
Suspension or Early Termination 
Early termination is the closure of a clinical study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single center. Suspension is a temporary postponement of study 
activities related to enrollment. This is possible for the whole study or a single center. 
Medtronic reserves the right to suspend or terminate the study or an individual study site at any time. 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• 
Adverse events associated with the system or product under investigation which might 
endanger the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent  
• 
Decision by Medtronic 
Possible reasons for clinical investigator or center termination or suspension include but are not limited 
to: 
• 
Failure to obtain initial IRB approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical study CIP (e.g. failure to adhere to inclusion/exclusion 
criteria, failure to follow subjects per scheduled follow-ups) 
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the clinical trial agreement (e.g. failure to 
submit data in a timely manner, failure to follow-up on data queries and monitoring findings in a 
timely manner, etc.) 
• 
IRB suspension of the center 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 

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• 
Investigator request (e.g. no longer able to support the study) 
16. References 
 
1. Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, 
Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency 
Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the 
Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 
2015;123(4):851-860. doi:10.1097/ALN.0000000000000774. 
2. Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Yearwood TL, 
Bundschu R, Yang T, Benyamin R, Burgher AH. Comparison of 10-kHz High-Frequency and Traditional 
Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month 
Results from a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. September 2016. 
doi:10.1227/NEU.0000000000001418. 
3. Van Buyten J-P, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the 
treatment of chronic back pain patients: results of a prospective multicenter European clinical study. 
Neuromodulation. 2013;16(1):59-65; discussion 65-66. doi:10.1111/ner.12006 . 
4. Tiede J, Brown L, Gekht G, Vallejo R, Yearwood T, Morgan D. Novel Spinal Cord Stimulation 
Parameters in Patients with Predominant Back Pain. Neuromodulation. 2013;16(4):370-375. 
doi:10.1111/ner.12032. 
5. Al-Kaisy A, Van Buyten J-P, Smet I, Palmisani S, Pang D, Smith T. Sustained Effectiveness of 10 kHz 
High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a 
Prospective Multicenter Study. Pain Med. 2013;15(3):347-354. doi:10.1111/pme.12294. 
6. Kinfe TM, Pintea B, Link C, Roeske S, Guresir E, Guresir A, Vatter H. High Frequency (10 kHz) or Burst 
Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients with Predominant Back Pain: 
Preliminary Data From a Prospective Observational Study. Neuromodulation. January 2016. 
doi:10.1111/ner.12379. 
7. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb 
and back pain. World Neurosurg. 2013;80(5):642-649.e1. doi:10.1016/j.wneu.2013.01.040. 
8. Kriek N, Groeneweg J, Stronks D, Huygen F. High frequency and burst spinal cord stimulations in 
patients with complex regional pain syndrome: A randomized placebo controlled trial. Pain Pract. 
2014;14:117. doi:10.1111/papr.12201. 
9. Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, 
placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the 
treatment of failed back surgery syndrome. Neuromodulation. 2014;17(5):443-450. 
doi:10.1111/ner.12197. 
10. Van Havenbergh T, Vancamp T, Van Looy P, Vanneste S, De Ridder D. Spinal Cord Stimulation for the 
Treatment of Chronic Back Pain Patients: 500-Hz vs. 1000-Hz Burst Stimulation. Neuromodulation. 
2014;18(1):9-12; discussion 12. doi:10.1111/ner.12252. 
11. Kriek N, Groeneweg JG, Stronks DL, Huygen FJPM. Comparison of tonic spinal cord stimulation, high-
frequency and burst stimulation in patients with complex regional pain syndrome: a double-blind, 
 

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randomised placebo controlled trial. BMC Musculoskelet Disord. 2015;16:222. doi:10.1186/s12891-015-
0650-y. 
12. Courtney P, Espinet A, Mitchell B, Russo M, Muir A, Verrills P, Davis K. Improved Pain Relief with 
Burst Spinal Cord Stimulation for Two Weeks in Patients Using Tonic Stimulation: Results from a Small 
Clinical Study. Neuromodulation. 2015;18(5):361-366. doi:10.1111/ner.12294. 
13. Kriek N, Groeneweg G, Huygen FJPM. Burst Spinal Cord Stimulation in a Patient with Complex 
Regional Pain Syndrome: A 2-year Follow-Up. Pain Pract. 2015;15(6):E59-E64. doi:10.1111/papr.12295. 
14. De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord stimulation: toward 
paresthesia-free pain suppression. Neurosurgery. 2010;66(5):986-990. 
doi:10.1227/01.NEU.0000368153.44883.B3. 
15. Medtronic (2016a) OPTIONS Final Clinical Study Report, version 2.0, 3 Nov 2016, (unpublished), 
ClinicalTrials.gov NCT02503787. 
16. Barolat G, Massaro F, He J, Zeme S, Ketcik B. Mapping of sensory responses to epidural stimulation 
of the intraspinal neural structures in man. J Neurosurg. 1993;78(2):233-239. 
doi:10.3171/jns.1993.78.2.0233.  
17. North JM, Kyung-Soo JH, Cho, PY. Clinical Outcomes of 1 kHz Subperception Spinal Cord Stimulation 
in Implanted Patients with Failed Paresthesia-Based Stimulation: Results of a Prospective Randomized 
Controlled Trial. Neuromodulation. 2016;19(7):731-37. 
18. North RB, Kidd DH, Olin J, Sieracki JM, Farrokhi F, Petrucci L, Cutchis PN. 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. doi:00007632-200506150-00012 [pii]. 
19. North RB, Kidd DH, Olin J, Sieracki JN, Petrucci L. Spinal cord stimulation for axial low back pain: a 
prospective controlled trial comparing 16-contact insulated electrodes with 4-contact percutaneous 
electrodes. Neuromodulation. 2006;9(1):56-67. doi:10.1111/j.1525-1403.2006.00043.x . 
20. North JM, Kyung-Soo JH, Cho, PY. Clinical Outcomes of 1 kHz Subperception Spinal Cord Stimulation 
in Implanted Patients with Failed Paresthesia-Based Stimulation: Results of a Prospective Randomized 
Controlled Trial. Neuromodulation. 2016;19(7):731-37. 
21. Medtronic, RestoreUltra and RestoreSensor HD Continuous and Cycling Stimulation Characterization 
Plan/Report, (internal document) NDHF1230-163807, version 2.0, 2017. 
22. Hakkinen A, Kautiainen H, Jarvenpaa S, Arkela-Kautiainen M, Ylinen J. Changes in the total Oswestry 
Index and its ten items in females and males pre- and post-surgery for lumbar disc herniation: a 1-year 
follow-up. Eur Spine J. Mar 2007;16(3):347-352. 
23. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). Nov 15 2000; 
25(22):2940-2952; discussion 2952. 
24. The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related quality of 
life. Health Policy 16(3):199-208. 

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17. Appendices  
There are no appendices within this clinical investigational plan. 
18. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Initial Release 
Sheryl McCammon, Principal 
Clinical Research Specialist