TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II
Conditions: Complex Regional Pain Syndrome (CRPS)
Sponsor: Abbott Medical Devices

Study Document No: SJM-CIP-10113 Ver. E 
Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
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Reference:  
SJM-CIP-10113 
Clinicaltrial.gov: NCT02800863 
 
 
TARGET: A Post-Approval Study to Evaluate Targeted SCS (DRG) Stimulation for the 
Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS 
Types I and II 
Clinical Investigation Plan (CIP) 
 
 
 
Sept 28th 2022 
 
Sponsor  
 
 
 
St. Jude Medical, Inc. (now part of Abbott) 
6901 Preston Road 
Plano, TX 75024 
USA 
 
 
 

Study Document No: SJM-CIP-10113 Ver. E 
Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
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Table of Contents 
Page 
 
Synopsis ........................................................................................................................ 3 
 
Background and Justification for Clinical Study .............................................................. 9 
 
Risks and Benefits of the Clinical Study ........................................................................10 
 
Objectives and Endpoints ..............................................................................................10 
 
Study Design .................................................................................................................11 
 
Study Devices ...............................................................................................................14 
 
Subject Selection ...........................................................................................................18 
 
Methods and Procedures ..............................................................................................19 
 
Adverse Events .............................................................................................................24 
 Data Analysis ................................................................................................................29 
 Subject Recruitment ......................................................................................................33 
 Subject Relocation ........................................................................................................33 
 Subject Withdrawal or Discontinuation ..........................................................................33 
 Compliance to CIP ........................................................................................................34 
 Amendments to Clinical Investigational Plan .................................................................35 
 Investigation Suspension or Termination .......................................................................35 
 Resuming the Study after Temporary Suspension .........................................................37 
 Administrative Requirements and Quality Assurance ....................................................37 
 Data Management .........................................................................................................37 
 Monitoring .....................................................................................................................38 
 Regulatory Inspections ..................................................................................................38 
 Document Retention ......................................................................................................38 
 Deviations from the Investigation Plan ...........................................................................39 
 Clinical Events Committee (CEC) ..................................................................................39 
 Publication Policy ..........................................................................................................39 
 Bibliography ..................................................................................................................40 
Appendix A: ABBREVIATIONS ..............................................................................................42 
Appendix B: CIP REVISION HISTORY ..................................................................................43 
APPENDIX C: DECLARATION OF HELSINKI .......................................................................43 
APPENDIX D: LIST OF CLINICAL INVESTIGATION SITES AND IRB ..................................44 
APPENDIX E: SAMPLE INFORMED CONSENT ...................................................................44 
APPENDIX F: CASE REPORT FORMS .................................................................................44 
APPENDIX G: INSTRUCTIONS FOR USE ............................................................................44 

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Clinical Investigational Plan  
 
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 SYNOPSIS  
Title: 
TARGET (DRG) Post-Approval Study 
Purpose: 
The ACCURATE study evaluated spinal column stimulation of the dorsal 
root ganglion (DRG) with the Axium Neurostimulator System for the 
treatment of chronic, intractable lower extremity neuropathic pain 
associated with a diagnosis of complex regional pain syndrome (CRPS) 
and peripheral causalgia (PC).  
 
The ACCURATE study met its primary endpoint and the results of the 
study provide reasonable assurance of safety and effectiveness of the 
Axium Neurostimulator System. The Axium Neurostimulator System was 
approved for sale in the United States by FDA and is indicated for spinal 
column stimulation via epidural and intra-spinal lead access to the dorsal 
root ganglion as an aid in the management of moderate to severe chronic 
intractable* pain of the lower limbs in adult patients with Complex 
Regional Pain Syndrome (CRPS) types I and II.** The Proclaim 
Neurostimulation System was subsequently approved for the same 
indication and is replacing the Axium device in commercial distribution. 
This post-approval study is a condition of FDA approval. 
 
*Study subjects from the ACCURATE clinical study had failed to achieve 
adequate pain relief from at least 2 prior pharmacologic treatments from at 
least 2 different drug classes and continued their pharmacologic therapy 
during the clinical study. 
 
**Please note that in 1994, a consensus group of pain medicine experts 
gathered by the International Association for the Study of Pain (IASP) 
reviewed diagnostic criteria and agreed to rename reflex sympathetic 
dystrophy (RSD) and causalgia, as complex regional pain syndrome 
(CRPS) types I and II, respectively. 
Primary Objective: 
The primary objective of this study is to demonstrate that the proportion of 
serious adverse effects (SAEs) at 12 months for subjects who receive the 
permanent Implantable Pulse Generator (IPG) is lower than a pre-
specified objective performance goal. 
Secondary 
Objectives: 
• 
To evaluate change in overall pain intensity 
• 
To evaluate change in physical function 
• 
To evaluate change in quality of life 
Primary Endpoint: 
The primary endpoint is the 12-month SAE rate for subjects receiving a 
permanent IPG.  
Secondary 
Endpoints: 
• 
Percent change from baseline to 12 months post-permanent 
implant for overall pain intensity measured using the Visual 
Analog Scale (VAS) 
• 
Change from baseline to 12 months post-permanent implant for 
physical function measured using the PROMIS-29 Profile  

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Clinical Investigational Plan  
 
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• 
Change from baseline to 12 months post-permanent implant for 
quality of life measured using the PROMIS Global Health Scale 
Descriptive 
Endpoints: 
Safety 
• 
Proportion of subjects with device, procedure or stimulation-
related SAEs and non-SAEs among subjects who receive the 
permanent implant  
• 
Proportion of subjects who have AEs related to the trial implant 
procedure among subjects who fail the trial neurostimulator 
phase 
• 
Summary of procedure-related SAEs and non-SAEs by 
implanter experience 
Effectiveness 
• 
Change from baseline to 1, 3, and 6 months post-permanent 
implant for overall pain intensity measured using the Visual 
Analog Scale (VAS) 
• 
Change from baseline to 1, 3, and 6 months post-permanent 
implant for physical function measured using the PROMIS-29 
Profile 
• 
Change from baseline to 1, 3, and 6 months post-permanent 
implant for quality of life measured using the PROMIS Global 
Health Scale 
• 
Change from baseline to 1, 3, 6 and 12 months post-permanent 
implant for neuropathic pain measured using the Neuropathic 
Pain Scale (NPS) 
• 
Change from baseline to 1, 3, 6 and 12 months post-permanent 
implant for sleep disturbance, anxiety, depression, fatigue, 
ability to participate in social roles and activities, pain 
interference and pain intensity measured using the PROMIS-29 
Profile 
• 
Patient Global Impression of Change (PGIC) at 1, 3, 6 and 12 
months post-permanent implant 
Design: 
This study is a prospective, single arm, observational post-approval study. 
Study follow-ups will occur at 1, 3, 6, and 12 months post-permanent 
implant.  
Devices used: 
DRG Neurostimulation System with Axium or Proclaim DRG Implantable 
Pulse Generator 
Study Population 
A maximum of 426 adult subjects with moderate to severe chronic, 
intractable pain of the lower limbs due to CRPS types I and II will undergo 
a trial of the neurostimulator system at up to 45 study sites in the United 
States.  
Inclusion/Exclusion 
Criteria  
Inclusion Criteria 
• 
Subject is male or female > 22 and < 75 years of age. 

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Clinical Investigational Plan  
 
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• 
Subject has moderate to severe chronic intractable pain of the 
lower limbs resulting from Complex Regional Pain Syndrome 
(CRPS) types I or II. 
• 
Subject has a baseline VAS score of > 60 mm for overall pain at 
the time of the baseline assessment. 
• 
Subject is willing and able to comply with the study 
requirements. 
• 
Subject is able to provide written informed consent. 
Exclusion Criteria 
• 
Subject has an active implantable medical device including but 
not limited to cardiac pacemakers and cardiac defibrillators. 
• 
Subject is currently involved in medically related litigation, 
including workers compensation. 
• 
Subject has a life expectancy of less than one year. 
• 
Subject is pregnant or of child bearing potential and not using 
adequate contraception as determined by the investigator. 
• 
Subject has, or plans to have, a spinal cord stimulation system 
or infusion pump system implanted. 
• 
Subject has, or plans to have, a peripheral nerve stimulation 
system (PNS) or peripheral nerve field stimulation system 
(PNfS) implanted. 
• 
Subject is considered to be a poor surgical or study candidate, 
which may include, but is not limited to the following:  any 
medical, social, or psychological problem that could complicate 
the implant procedure and/or recovery from the implant 
procedure or could complicate the required procedures and 
evaluations of the study in the judgment of the investigator. 
Data Collection 
The following activities will occur during the study: 
 
Baseline Visit 
• 
Subject signs informed consent 
• 
Subject evaluated for eligibility 
• 
Brief treatment history 
• 
Pain mapping 
• 
Subject completes VAS, NPS, PROMIS-29 Profile, and PROMIS 
Global Health  
• 
Schedule system trial implant 
 
Trial System Implant (approximately 30 days from Baseline visit) 
• 
Trial system implantation  
• 
Program device  
• 
Provide subject with the trial neurostimulator 
• 
Record AEs (if necessary) 

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Clinical Investigational Plan  
 
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• 
Schedule End of System Trial visit 
 
End of System Trial Visit (length determined by the site’s standard of 
care; typically 3-12 days after trial system implantation) 
• 
Document subject trial system evaluation results 
• 
Collect programming parameters  
• 
Remove trial leads 
• 
Record AEs (if necessary) 
• 
Schedule permanent system implant (if applicable) 
• 
Schedule 1-Month safety follow-up call (if necessary) 
 
Permanent System Implant (approximately 30 days from End of System 
Trial visit) 
• 
Permanent system implantation  
• 
Record AEs (if necessary) 
• 
Schedule device activation visit 
 
Device Activation (timing determined by the site’s standard of care; may 
occur at the time of permanent system implant) 
• 
Program device 
• 
Provide subject with the patient programmer 
• 
Record AEs (if necessary) 
• 
Schedule 1-Month follow-up visit 
 
1 Month (± 14 days) Follow-up Visit 
• 
Subject completes VAS, NPS, PGIC, PROMIS-29 Profile, and 
PROMIS Global Health 
• 
Stimulation assessment 
• 
Collect programming parameters  
• 
Modify programming parameters (if necessary) 
• 
Record AEs (if necessary) 
• 
Schedule 3-Month follow-up visit 
 
3 Month (± 14 days) Follow-up Visit 
• 
Subject completes VAS, NPS, PGIC, PROMIS-29 Profile, and 
PROMIS Global Health 
• 
Stimulation assessment 
• 
Collect programming parameters 
• 
Modify programming parameters (if necessary) 
• 
Record AEs (if necessary)  
• 
Schedule 6-Month follow-up visit 
 
6 Month (± 14 days) Follow-up Visit 
• 
Subject completes VAS, NPS, PGIC, PROMIS-29 Profile, and 
PROMIS Global Health 
• 
Stimulation assessment 
• 
Collect programming parameters  

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Clinical Investigational Plan  
 
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• 
Modify programming parameters (if necessary) 
• 
Record AEs (if necessary) 
• 
Schedule 12-Month follow-up visit  
 
12 Month (± 30 days) Follow-up Visit 
• 
Subject completes VAS, NPS, PGIC, PROMIS-29 Profile, and 
PROMIS Global Health 
• 
Stimulation assessment 
• 
Collect programming parameters 
• 
Record AEs (if necessary)  
• 
Modify programming parameters (if necessary) 
• 
Exit subject from study 
 
 
 
Revisions, Replacements or Explants (additional surgery) 
• 
Revision, replacement or explant procedure 
• 
Modify programming parameters (if necessary) 
• 
Record AEs  
• 
Schedule 1-Month safety follow-up call (if necessary) 
 
Unscheduled Visits (occurring after the permanent implant) 
• 
Modify programming parameters (if necessary) 
• 
Record AEs (if necessary) 
 
 
 

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Clinical Investigational Plan  
 
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STUDY CONTACTS 
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Clinical Investigational Plan  
 
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 BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
Chronic pain affects approximately 30% of the total United States population with an estimated 
100 million adult pain patients in the United States alone.1 Direct medical treatment costs, as 
well as lost productivity, costs the United States $560–635 billion each year and chronic pain 
rates are likely to continue to rise.1 Chronic pain substantially diminishes a patient’s quality of 
life and is often a debilitating condition. Current therapies for chronic pain include oral 
medications, physical and behavioral therapies, complementary and alternative medicine, 
injectable therapies, neuroablative techniques, transcutaneous electrical nerve stimulation, and 
ultimately surgical procedures such as spinal fusion and discectomy. Up to 15% of all chronic 
pain patients are unresponsive to standard medical therapy, exhausting all first- and second-line 
options and reaching the end of the treatment continuum.1 Since its approval by the Food and 
Drug Administration (FDA) in 1989, neurostimulation techniques, including spinal cord 
stimulation (SCS), have traditionally been recommended as a last resort therapy for patients 
who have exhausted all other options.  
 
Given that up to 15% of all chronic pain patients are unresponsive to standard medical therapy, 
spinal cord stimulation (SCS) is becoming an increasingly popular tool for the management of 
chronic, intractable pain, with an estimated 40,000 SCS systems implanted every year in the 
United States.2 SCS has been used successfully to treat a variety of pain conditions including, 
diabetic neuropathy3, failed back surgery syndrome4-7, complex regional pain syndrome8-10, 
phantom limb pain11, ischemic limb pain12, refractory unilateral limb pain syndrome13, and 
postherpetic neuralgia and acute herpes zoster pain.14 However, a recent systematic review 
showed that almost 50% of patients did not respond favorably to SCS when trial failures were 
included in the analysis.15 
 
Stimulation of the dorsal root ganglion (DRG) may provide an additional option for chronic pain 
patients with several potential advantages over conventional SCS. One such potential 
advantage is providing targeted therapy for focal pain conditions. This ability to target may result 
from 1) the ability to control current delivered to the DRG with minimal shunting of energy in the 
cerebral spinal fluid (CSF), as is the case with the dorsal columns, 2) spinally segmented 
sensory input, and, 3) the ability to control the electrical field around the DRG through device 
programming.  
 
The safety and efficacy of the use of DRG stimulation for the treatment of patients diagnosed 
with chronic intractable pain of the lower limbs is supported by data from a prospective, 
randomized, multicenter, controlled clinical trial. The ACCURATE Investigational Device 
Exemption (IDE) trial was approved by FDA to assess the safety and efficacy of DRG 
stimulation with the Axium Neurostimulator System for individuals with chronic lower limb pain 
associated with Complex Regional Pain Syndrome (CRPS I) or Peripheral Causalgia (CRPS II). 
In this study, 152 subjects (76 randomized to each the treatment and control group, where 
treatment was DRG stimulation and control was SCS) were enrolled across 22 investigational 
sites. The primary endpoint was the percentage of subjects who were considered treatment 
successes in the treatment group (DRG stimulation) compared to the control group (traditional 
SCS), where a treatment success was defined as a subject with at least a 50% lower limb(s) 
pain reduction on a visual analog scale (VAS) compared to baseline in the area of greatest 
baseline pain during both the trial stimulation phase and at the 3 month follow-up, and the 
absence of a stimulation-induced neurological deficit. The primary analysis was a test of non-

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inferiority between the DRG stimulation group compared to the SCS group with a pre-specified 
10% non-inferiority margin. The study met the primary endpoint with statistically significantly 
more treatment successes in the DRG stimulation group compared to the SCS group at 3 
months post permanent implant (81.2% vs. 55.7%, respectively; p = 0.0004). This effect 
persisted at 12 months post implant (74.2% vs. 53.0%; p=0.0047). Secondary and tertiary 
outcomes including percent change in VAS scores, change in SF-36 scores, change in Profile of 
Mood States (POMS) scores, and change in Brief Pain Inventory (BPI) scores were also 
suggestive of improvements in the group who received DRG stimulation compared to the SCS 
group.  
 
The most commonly reported definitely-related adverse events (AEs) in the group who received 
DRG stimulation with the Axium Neurostimulator System in the ACCURATE IDE study were 
pain at the implantable pulse generator (IPG) pocket (14.5% of subjects) and loss of stimulation 
due to lead migration (11.8% of subjects). There were a total of 21 serious adverse events 
(SAEs) in 19 subjects reported in this study. The difference in overall rate of SAEs between the 
Axium and Control groups was not found to be statistically significantly different (Axium 10.5%, 
Control 14.5%, p=0.6248). Additionally, the overall difference in the rate of SAEs during the 
system trial (Axium 1.3%, Control 3.9%, p=0.62) and after the permanent implant (Axium 9.2%, 
Control 10.5%, p=1.0) were not shown to be statistically significantly different. Only 1 serious 
adverse device effect (SADE; cardiac arrhythmia post-implant) was classified as possibly or 
definitely related to the device, procedure and/or stimulation in the group, which received the 
Axium Neurostimulator System. There were no reports of stimulation induced neurological 
deficits in either the control or Axium group at any point in the study. 
 
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  RISKS AND BENEFITS OF THE CLINICAL STUDY 
There are no additional risks of the clinical study beyond those associated with the implant and 
use of the FDA-approved trial and permanent neurostimulator systems. Please refer to Section 
9.3 for the list of anticipated adverse events. 
 
 OBJECTIVES AND ENDPOINTS 
 
Primary Objective 
The primary objective of this study is to demonstrate that the proportion of serious adverse 
events (SAEs) at 12 months for subjects who receive the permanent DRG IPG is lower than a 
pre-specified performance goal. 
 
Secondary Objectives 
Secondary objectives of this study are as follows: 
• 
To evaluate change in overall pain intensity 
• 
To evaluate change in physical function 
• 
To evaluate change in quality of life 
 
Primary Endpoint 
The primary endpoint is the 12-month SAE rate for subjects receiving the permanent DRG IPG.  

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XXXXXX. 
 
Secondary Endpoints 
 
 
Secondary endpoints include: 
• 
Percent change from baseline to 12 months post-permanent implant for overall pain 
intensity measured using the Visual Analog Scale (VAS) 
• 
Change from baseline to 12 months post-permanent implant for physical function 
measured using the PROMIS-29 Profile 
• 
Change from baseline to 12 months post-permanent implant for quality of life 
measured using the PROMIS Global Health Scale 
 
Descriptive Endpoints 
Safety 
• 
Proportion of subjects with device, procedure or stimulation-related SAEs and non-
SAEs among subjects who receive the permanent implant  
• 
Proportion of subjects who have AEs related to the trial implant procedure among 
subjects who fail the trial neurostimulator phase 
• 
Summary of procedure-related SAEs and non-SAEs by implanter experience 
Effectiveness 
• 
Percent change from baseline to 1, 3, and 6 months post-permanent implant for 
overall pain intensity measured using the Visual Analog Scale (VAS) 
• 
Change from baseline to 1, 3, and 6 months post-permanent implant for physical 
function measured using the PROMIS-29 Profile 
• 
Change from baseline to 1, 3, and 6 months post-permanent implant for quality of life 
measured using the PROMIS Global Health Scale 
• 
Change from baseline to 1, 3, 6 and 12 months post-permanent implant for 
neuropathic pain measured using the Neuropathic Pain Scale (NPS) 
• 
Change from baseline to 1, 3, 6 and 12 months post-permanent implant for sleep 
disturbance anxiety, depression, fatigue, ability to participate in social roles and 
activities, pain interference and pain intensity measured using the PROMIS-29 Profile  
• 
Patient Global Impression of Change (PGIC) at 1, 3, 6 and 12 months post-
permanent implant 
 
Additional Data 
Additional data, including but not limited to, percentage of subjects achieving at least a 30% and 
50% pain reduction, demographics, paresthesia coverage and intensity, subject satisfaction, 
programming parameters, implant procedure information, and system information may be 
compiled.  
 
 STUDY DESIGN 
This study is a prospective, multicenter, single arm, observational post-approval study with 
follow-ups at 1, 3, 6 and 12 months post-permanent implant. The clinical study will be conducted 

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at up to 45 centers in the United States. A maximum of 426 subjects will be enrolled to achieve 
319 subjects with a permanently implanted system, which will account for expected attrition, to 
yield 287 subjects for the primary analysis at 12 months post-implant (See Section 10.9 Sample 
Size for full details). After the last subject with a permanently implanted device reaches the 12-
month study visit or crosses the 12-month study visit window, the endpoint analysis will be 
conducted and reported to the FDA.   
 
After the subject signs the informed consent, s/he will be screened according to the 
inclusion/exclusion criteria and will undergo a baseline evaluation. Those subjects who meet the 
criteria for participation will undergo a trial of the DRG Neurostimulation System to assess 
response to DRG stimulation. Only subjects who report a 50% or greater reduction in overall 
pain intensity through direct patient-reported percentage of pain relief will receive the permanent 
implant. Device activation will occur according to the site’s standard of care and may occur at 
the time of permanent system implant. Subjects will then return to the office for follow-up at 1, 3, 
6 and 12 months post-permanent implant. Figure 2 below outlines subject flow through the 
study. 
 
 
 

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. This timeline may change the actual enrollment rate 
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. 

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Estimated time needed to enroll this subject population 
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Justification for Study Design 
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 STUDY DEVICES 
All study devices are in commercial distribution in the United States as aids in the management 
of CRPS I and II. St. Jude Medical (SJM) received FDA approval for the Axium Neurostimulator 
System under PMA P150004 on February 11, 2016 and approval for the Proclaim DRG IPG 
under PMA supplement P150004/S002 on November 28, 2016. The components of the DRG 
Neurostimulation Systems to be used in this study include the following devices: 

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Table 1: Description of Devices 
Device 
Component 
Model 
50 cm SlimTip Trial Lead Kit 
MN10350-50A 
90 cm SlimTip Trial Lead Kit 
MN10350-90A 
50 cm SlimTip Implant Lead Kit 
MN10450-50A 
90 cm SlimTip Implant Lead Kit 
MN10450-90A 
Lead Accessories Kit 
MN12050 
22 cm Small Curve Delivery Sheath Kit MN12150 
22 cm Big Curve Delivery Sheath Kit 
MN13650 
Implantable Neurostimulator Kit (Axium 
Neurostimulator System) 
MN10200 
Proclaim DRG IPG 
3664 
Connector Cable 
MN11350 
30 cm Small Tunneling Tool Kit 
MN11950 
Clinician Programmer 
MN10700 
Patient Programmer 
MN10600-02 
St. Jude Medical Clinician Programmer 
App 
3874 
St. Jude Medical Patient Controller App 3875 
Trial Neurostimulator 
MN10100 
DRG External Pulse Generator  
7599 (Base) 
7032 (Header) 
Auxiliary Magnet Kit 
MN23300 
Programmer Charger Kit 
MN23400 
Programmer Carrying Case 
MN13500 
50 cm Lead Extension Kit 
MN10550-50 
Curved Needle 
MN14000 
Tunneling Tool 
MN15000 
 
 
SlimTip Lead Kits (MN10350-50A, MN10350-90A, MN10450-50A, MN10450-90A) 
The leads are designed for percutaneous introduction into the body using a 14-gauge needle 
and a set of custom delivery tools provided in each kit. The lead is designed to provide 
stimulation to the intended DRG. It has four cylindrical electrodes spaced at 5 mm intervals on 

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the distal end.  The proximal end fits into a four-conductor connector on the connector cable into 
a four-conductor connector on the extension lead, or into the header of the implantable 
neurostimulator. The straight stylet is pre-inserted into the lead and the lead is pre-loaded into 
the sheath during manufacturing. 
The SlimTip trial lead kit and implant lead kit contains the lead and the individual delivery 
devices required to place the lead(s). The lead comes in two lengths 50cm and 90cm. The 
straight stylet is intended to assist in steering and positioning the lead within the epidural space 
and is inserted into the leads during manufacturing. A curved stylet is also included in the kit as 
an option. The delivery needle is intended to access the epidural space, providing a conduit for 
the lead, guidewire, and delivery sheaths. The suture anchors are intended to anchor the leads 
to the soft tissue or skin surface proximal to the distal contacts. The guidewire is optional and is 
intended to verify that the needle is in the epidural space after using a loss of resistance 
technique. 
The delivery sheaths are intended to help deliver the lead percutaneously into the epidural 
space and are available in two lengths: (22cm and 30cm) as well as two curve shapes (small 
curve and big curve). 
Lead model MN10450-50A is MR Conditional when used in conjunction with Proclaim DRG 
IPG. 
 
Lead Accessories Kit (MN12050) 
The lead accessories kit consists of additional tools to aid lead delivery. A 50cm lead extension 
is packaged with a torque wrench to enable the physician to extend the length of the lead or to 
provide a connection from the implant lead to the connector cable. The lead extension is 
intended for chronic implantation. A connector cable (MN11350) is provided in a separate 
package to connect the leads or lead extension to the trial neurostimulator.  
 
Tunneling Tool Kit (MN11900) 
A 30cm tunneling tool is available with associated accessories to provide a conduit for the lead 
or lead extension to pass under the skin away from the midline of the spine. The tunneling tool 
is packaged with two exchangeable tips: a blunt pencil tip and a sharp trocar tip. A straw slides 
over the tunneling tool and then the steel handle removed. The straw provides the conduit for 
tunneling. An implantable neurostimulator sizer is packaged with the tunneling tool to allow the 
physician to properly size the pocket for the stimulator.  
 
Tunneling Tool (Model MN15000) 
The tunneling tool is used to provide a conduit for the lead or lead extension to the IPG or away 
from the midline of the spine. It is packaged with two exchangeable tips (a blunt pencil tip and a 
sharp trocar tip), a straw, a hex key, and a torque wrench. 
 
Trial Neurostimulator (MN10100) 
The external trial neurostimulator provides energy and controls electrical signals delivered to the 
leads. It has a belt clip and must be worn over a piece of clothing by the subject.  

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DRG External Pulse Generator (EPG; 7599 & 7032) 
The DRG EPG functions in the same way as the MN101000 but is compatible with the same 
programming platform as the Proclaim DRG. 
 
 
Implantable Neurostimulator Kit (MN10200) 
The implantable neurostimulator provides energy and controls electrical signals delivered to the 
leads. It is typically implanted by the physician in the abdomen or buttocks. 
 
 
Proclaim DRG IPG, MR Conditional (Model 3664) 
The Proclaim DRG IPG was developed based on the FDA approved Proclaim SCS and Axium 
DRG pulse generators. It is a 16-channel, 4-port, non-rechargeable, MR Conditional IPG. The 
internal electronics, battery and external casing (can) are identical to the Proclaim SCSIPG used 
for SCS indications (Model 3660 and 3665). The Proclaim DRG uses the Axium header design 
(adapted for the Proclaim IPG cannister) which accommodates up to four DRG leads. Additionally, 
the firmware capability for Proclaim DRG was developed to match the capabilities of the Axium 
pulse generator. A pocket sizer is an accessory packaged with the IPG and is used to assess the 
implant size for the IPG. The Proclaim DRG pocket sizer is made of the same material used in the 
FDA approved Proclaim SCS pocket sizer, but with a different design to reflect the Proclaim DRG 
IPG shape and form. 
 
Patient Programmer (MN10600-02) 
The patient programmer is set up under the instruction of the clinician or clinical staff to allow 
the subject to change the amplitude of the energy delivered by the implantable or trial 
neurostimulator system. The subject carries the programmer with them during daily use. 
The patient programmer is powered by an internal rechargeable battery or it is plugged into a 
power outlet using the power supply cord provided. The patient programmer will be used by the 
subject to communicate with their implantable or trial neurostimulator system, to monitor the 
device, and to adjust the stimulation settings within their Investigator’s prescribed limits. The 
subject is provided with a carrying case (MN13500) for carrying their patient programmer during 
their participation in this study. 
The patient programmer has the following features: 
• 
Turns OFF all stimulation 
• 
Turns stimulation ON or OFF for each body region to be treated 
• 
Adjusts stimulation amplitude for each lead in use 
• 
Shows the subject’s identification information 
• 
Shows Investigator name and clinic name, along with contact information 
The patient programmer contains an internal magnet to initiate communication with the 
implantable or trial neurostimulator system. The patient programmer is designed to be easy to 
use and establishes two-way communication with the implantable or trial neurostimulator 
system to control the stimulation delivered to the subject.  

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Clinician Programmer (MN10700) 
The clinician programmer is used by trained staff under the guidance of the clinician to 
communicate wirelessly with the implantable and/or trial neurostimulator system.  
The clinician programmer has the following features: 
• 
Turns OFF all stimulation 
• 
Turns stimulation ON for up to four leads and measures lead impedance 
• 
Allows the user to assign body regions that each individual lead is intended to stimulate, 
modify electrode configurations and adjust stimulation settings for each lead 
• 
Creates multiple groups of stimulation settings for the subject 
• 
Enters subject and lead identification information, Investigator and clinic name and 
contact information, and Investigator’s notes 
• 
Performs real time test stimulation to assess the subject’s response for each lead 
• 
Enables subject-controlled therapy and configures subject-controlled therapy settings for 
each lead 
• 
Acquires identification, diagnostic, and historic information about the neurostimulator 
device 
• 
Programs configured therapy settings for continuous stimulation 
The clinician programmer contains an internal magnet to initiate communication with the 
implantable or trial neurostimulator device.  
 
Clinician Programmer App (Model 3874 Version 3.3) 
The stimulation parameter ranges allowed by Clinician Programmer App (Model 3874 Version 
3.3) are the same as the approved Axium system. The IPG stimulation settings are established 
via the Clinician Programmer (CP) App, which is installed on an off-the-shelf Apple iPad Mini. 
Different stimulation programs may be stored and selected via the Patient Controller (PC) App, 
which is installed on an off-the-shelf Apple iPod Touch. The clinician programmer communicates 
with the pulse generator via Bluetooth. 
 
Patient Controller App (Model 3875 Version 3.3) 
The stimulation parameter ranges allowed by the patient controller App (Model 3875 Version 3.3) 
are the same as the approved Axium system. The IPG stimulation settings are established via the 
Clinician Programmer (CP) App, which is installed on an off-the-shelf Apple iPad Mini. Different 
stimulation programs may be stored and selected via the Patient Controller (PC) App, which is 
installed on an off-the-shelf Apple iPod Touch. The patient controller communicates with the pulse 
generator via Bluetooth. 
 
 SUBJECT SELECTION 
Subjects who meet all of the inclusion criteria and none of the exclusion criteria are eligible to 
participate in this study. All subjects in the clinical study (including system trial failures, those 
withdrawn from the clinical study and those lost to follow-up) will be accounted for and 
documented by assigning an identification code linked to their name, alternative identification or 

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contact information. This log will be kept up to date throughout the clinical study by the principal 
investigator or his/her authorized designee.  
 
Inclusion Criteria 
To participate in this clinical study, the subject must meet all of the following inclusion criteria: 
• 
Subject is male or female ≥ 22 and ≤ 75 years of age. 
• 
Subject has moderate to severe chronic intractable pain of the lower limbs resulting from 
Complex Regional Pain Syndrome (CRPS) types I or II. 
• 
Subject has a baseline VAS score of > 60 mm for overall pain at the time of the baseline 
assessment. 
• 
Subject is willing and able to comply with the study requirements. 
• 
Subject is able to provide written informed consent. 
 
Exclusion Criteria 
Subjects are not eligible for this clinical study if they meet any of the following exclusion criteria: 
• 
Subject has an active implantable medical device including but not limited to cardiac 
pacemakers and cardiac defibrillators. 
• 
Subject is currently involved in medically-related litigation, including workers 
compensation. 
• 
Subject has a life expectancy of less than one year. 
• 
Subject is pregnant or of child bearing potential and not using adequate contraception 
as determined by the investigator. 
• 
Subject has, or plans to have, a spinal cord stimulation system or infusion pump 
system implanted. 
• 
Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or 
peripheral nerve field stimulation system (PNfS) implanted. 
• 
Subject is considered a poor surgical or study candidate, which may include, but is 
not limited to the following:  any medical, social, or psychological problem that could 
complicate the implant procedure and/or recovery from the implant procedure or could 
complicate the required procedures and evaluations of the study in the judgment of 
the investigator. 
 
 METHODS AND PROCEDURES 
 
Study Procedures 
The clinical study will be conducted in accordance with the CIP. All parties participating in the 
conduct of the clinical study will be qualified by education, training, or experience to perform 
their tasks. The clinical study will not commence until St. Jude Medical receives written approval 
from the IRB and relevant regulatory authorities and all required documents have been collected 
from the site. 
 
All required study procedures at each specified interval are outlined in the sections below. A 
table outlining the timing of all study activities by each visit is located at the end of this section.  

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Informed Consent 
XXXX 
 
Blinding 
There is no blinding for the subject or the Investigator. 
 
Subject Screening and Point of Enrollment 
All subjects presenting at the investigational site will be screened by a member of the 
investigational team previously trained on the CIP and delegated to do so. After completion of 
the baseline visit, eligible subjects will be scheduled for the trial system implant. XXXXX 
 
Baseline Visit 
Baseline measurements for the subject’s pain symptoms and location will be taken along with a 
brief treatment history and completion of subject self-reported questionnaires. 
 
The following information will be collected at the baseline visit: 
• 
Demographics 
• 
Diagnosis 
• 
Pain and treatment history 
• 
VAS score 
• 
NPS 
• 
PROMIS-29 Profile domain scores 
• 
PROMIS Global Health Scale score 
• 
Protocol Deviations (if applicable) 
 
Trial System Implant (approximately 30 days from Baseline Visit) 
Subjects will use the trial system in accordance with the standard practice of the clinical site 
(typically 3-12 days). Trial system activation will occur in post-operative recovery after the 
implantation. At each visit, SJM field representatives may assist with programming of the 
subject’s device under the supervision of the investigative team. 
 
The following information will be collected at the trial system implant visit:XXXX 
 
End of System Trial Visit (length determined by the site’s standard of care; typically 
3-12 days after trial system implantation) 
At the end of the system trial phase, subjects will complete their trial system evaluation prior to 
removal of the system components. Only subjects who report a 50% or greater reduction in 
overall pain intensity through direct patient-reported percentage of pain relief will be eligible to 
receive the permanent implant.. The subject will then be withdrawn from the study. 
 
The following information will be collected at the end of the system trial visit: 
• 
Programming parameters 
• 
Length of trial (days) 
• 
Pain relief (direct patient report of percentage of pain relief) 
• 
Decision on whether to proceed to permanent implant 
• 
Reason subject will not proceed to the permanent implant (if applicable) 

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• 
AEs (if applicable) 
• 
Protocol Deviations (if applicable) 
 
Permanent System Implant (approximately 30 days from End of System Trial visit) 
The permanent implant should occur approximately 30 days from the End of System Trial visit. 
The following information will be collected at the permanent system implant visit: 
• 
Procedure information 
• 
Device information 
• 
AEs (if applicable) 
• 
Protocol Deviations (if applicable) 
 
Device Activation (timing determined by the site’s standard of care; may occur at 
the time of permanent system implant) 
Permanent system device activation will occur according to the site’s standard of care and may 
occur at the time of the permanent system implant. At each visit, SJM field reps may assist with 
programming of the subject’s device under the supervision of the investigative team. 
 
The following information will be collected at the activation visit: 
• 
AEs (if applicable) 
• 
Protocol Deviations (if applicable) 
 
Scheduled Follow-ups  
Subjects will report to the office at 1 (+14 days), 3 (+14 days), 6 (+14 days), and 12 (+30 days) 
months after the activation visit. The following information will be collected at these visits: 
• 
VAS score 
• 
NPS 
• 
PROMIS-29 Profile domain scores 
• 
PROMIS Global Health Scale score 
• 
PGIC score 
• 
Change in occupational status 
• 
Change in activity level 
• 
Satisfaction with device/therapy 
• 
Willingness to undergo the procedure again 
• 
Willingness to recommend the procedure to someone 
• 
Sensations generated by stimulation 
• 
Programming parameters 
• 
AEs (if applicable) 
• 
Protocol Deviations (if applicable) 
All information, including subject questionnaires, should be collected prior to reprogramming, if 
reprogramming is needed. Missed visits and visits that occur outside of the specified time 
windows will be documented as protocol deviations. 
If a study participant is unable or unwilling to attend an in-person visit, the visit may be 
conducted remotely using telemedicine as provided by the study center. Questionnaires may be 

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administered during the remote visit. The numeric rating scale (NRS) may be used to collect a 
subject’s pain score in place of the visual analog scale. Both are valid measures of pain 
intensity and studies support a strong relationship between both 23, 24. The Coordinator or 
designee must document the subject’s responses on the worksheet, note that the responses 
were collected via phone, save that document as source data, and enter the information in the 
EDC system. Alternately, questionnaires may be mailed to the participant in a return postage 
provided envelope. If this method is chosen, the Coordinator or designee should schedule a call 
with the subject to clearly explain the questionnaires and answer any questions the subject may 
have.  
  
 
Revisions, Replacements, or Explants (Additional Surgery) 
The subject and the implanting physician will collectively make the decision about any possible 
revision of the device based upon what is medically safe, what is desired by the subject, and 
what is in the subject’s best medical interests. Any system revision, replacement or explant will 
be recorded on the appropriate eCRFs. If the device is explanted for any reason and re-
implantation is not an option, the subject will be followed for 1 month post-explant and then 
withdrawn from the study. Subjects who undergo a revision or replacement procedure will 
resume their previous follow-up schedule. 
 
Unscheduled Visits 
An unscheduled visit is defined as any visit that occurs outside of a specified study visit. Only 
unscheduled visits occurring after the permanent implant will be recorded. Examples of 
unscheduled visits may include subjects returning to the office for an AE or programming 
change. 

 
 
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Table 1: List of all study specific activities/procedures 
  (XXXXX if applicable 
 
 
 
 
 
Validated Questionnaires 
All validated questionnaires should be completed prior to reprogramming as applicable. The 
Study Coordinator or designee will give the subject the questionnaires to complete on his or her 
own. It is important that the subject understands the meaning of all the words in the 
questionnaires. The subject should be instructed to ask any questions about the questionnaires 
if further explanation is needed. Once the subject has completed the questionnaire, the Study 
Coordinator or designee will review the questionnaire for completeness to verify that all 
questions have been answered and only one response is chosen for each item. 
 
Visual Analog Scale (VAS) for Pain 
The VAS is a common, self-administered measure in which subjects rate their pain intensity by 
marking a vertical line through a 100 mm horizontal line anchored by word descriptors on each 
end (no pain to worst imaginable pain). The distance between the beginning of the horizontal 
line and the vertical line is measured to produce a score between 0 and 100 mm (or 0 to 10 cm). 
A higher score indicates higher pain intensity and a 30% reduction in VAS score from baseline 
to follow-up is considered clinically relevant.16 VAS scores for overall pain intensity will be 
collected. 
 
Numeric Rating Scale for Pain (telemedicine visits) 
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will 
be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 
24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater 
pain intensity 
 
 
Neuropathic Pain Scale (NPS)17 
The NPS is a self-administered validated questionnaire designed to assess pain qualities and 
symptoms associated with neuropathic pain. The questionnaire is comprised of 10 scales which 
assess two global pain domains (pain intensity and unpleasantness), six specific pain qualities 
(sharp, dull, sensitive, hot, cold, and itchy pain), and two spatial qualities (deep and surface 
pain). Respondents rate the intensity or severity of each descriptor item on a scale from 0 to 10, 
where 0 represents no intensity/severity and 10 represents the most intensity/severity. The 
questionnaire takes 5 minutes to complete and yields scores for each pain quality/symptom as 
well as an overall mean score for all 10 scales. The NPS can be used to differentiate 
neuropathic pain from non-neuropathic pain. Mean scores of 5.5 or greater reflect presence of 
neuropathic pain whereas those below 5.5 reflect non-neuropathic pain.18 
 
PROMIS-29 Profile v2.0 19-20 
The PROMIS-29 Profile is an instrument made up of seven individual short forms (physical 
function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and 
activities, pain interference) that are scored individually. The instrument also includes a single 

 
 
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pain intensity item which is reported as its raw score (e.g., 0 to 10). Each item has five response 
options ranging in value from 1 to 5, except for the Pain Intensity item which has eleven 
response options ranging in value from 0 to 10. A raw score is created from each short form that 
makes up the Profile. Raw scores are calculated by summing the values of the response to 
each question within each domain. For example, for the 29-item Profile, the lowest possible raw 
score within anxiety is 4 (a score of 1 on all four items); the highest possible raw score is 20. 
Raw scores are converted into t-scores, where higher scores represent more of the concept 
being measured (i.e. physical function). For the depression, anxiety, physical function, pain 
interference, fatigue profile domains, a t-score of 50 is the average for the US general 
population with a standard deviation of 10. For the Ability to Participate in Social Roles and 
Activities and Sleep Disturbance profile domains, a score of 50 represents the average of a 
calibration sample, which generally contained more individuals with chronic illness. Thus, a 
score of 50 likely represents somewhat sicker people than the general population. 
PROMIS Global Health Version 1.1 
The PROMIS Global Health short form is a validated, 10-item instrument designed to assess 
multiple health domains.19 The questionnaire yields a total score and sub-scale scores for 
Global Physical and Mental Health. Each question has potential five response options ranging in 
value from one to five to give a total score ranging from 10 to 50. All questions must be 
answered to arrive at a total score as one or more missing responses will render scores 
unusable. Scores are converted into t-scores where the average for the general US population 
is 50 and the SD is 10. Higher scores indicate better global health. 
Patient Global Impression of Change (PGIC)21 
The PGIC is the most commonly used patient-reported, anchor based method of assessing 
clinically important change.22 The PGIC consists of one question to assess change in activity 
limitations, symptoms, emotions, and overall quality of life related to their condition rated on a 
seven-point Likert scale. PGIC values of 6 or more are reported to correlate best with actual 
change.22 
 
Study Conclusion 
When the subject’s participation in the clinical study has been completed, the subject will return 
to medical care as per their physician’s recommendation. The study will be concluded when all 
sites are closed and the final report generated by St. Jude Medical has been provided to sites or 
St. Jude Medical has provided formal documentation of study closure. 
 ADVERSE EVENTS 
 
Definitions 
9.1.1 
Medical Device 
Any instrument, apparatus, machine, appliance, implant, software, material or other similar or 
related article intended by the manufacturer to be used, alone or in combination, for human 
beings for one or more of the specific purpose(s) of:  
• 
Diagnosis, prevention, monitoring, treatments or alleviation of disease,  
• 
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,  
• 
Investigation, replacement, modification, or support of the anatomy or of a physiological 
process,  
• 
Supporting or sustaining life,  

 
 
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• 
Control of conception,  
• 
Disinfection of medical devices and 
• 
Which does not achieve its primary intended action in or on the human body by 
pharmacological, immunological or metabolic means, but which may be assisted in its 
intended function by such means. 
9.1.2 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related 
to the medical device under study. This definition includes events related to the medical device  
and to the procedures involved. 
 
9.1.3 
Serious Adverse Event (SAE) 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP, are 
not considered SAEs. 
9.1.4 
Adverse Device Effect (ADE) 
An AE related to the use of a medical device used in this study. 
This definition includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the medical device. 
This definition includes any event resulting from the use error or from intentional misuse of the 
medical device. 
9.1.5 
Serious Adverse Device Effect (SADE). 
 
Assessing, Recording and Reporting AEs 
Safety surveillance within this study and the safety reporting both performed by the investigator, 
starts as soon as the subject is consented for the study. The safety surveillance and the safety 
reporting will continue until the last investigational visit has been performed, the 
subject/investigator concludes his participation into the study or the subject/investigator withdraws 
the subject from the study, except as otherwise specified in the CIP. 
Records related to the subject’s subsequent medical course must be maintained and submitted 
(as applicable) to the Sponsor until the event has subsided or, in case of permanent impairment, 
until the event stabilizes and the overall clinical outcome has been ascertained. All AEs will be 
monitored until they are adequately resolved. The status of the subject’s condition should be 
documented at each visit. 
AE data will be collected throughout the clinical study and will be reported to the Sponsor on a 
dedicated case report form through the EDC system. Reportable events to sponsor are 
considered:  
1. All SAEs (whether or not the event is device and/or procedure related)  
2. All procedure, device and/or stimulation-related AEs (whether or not the event is 
considered serious) 
Device, procedure, and stimulation-related AEs are defined as follows: 

 
 
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• 
Device-related: A malfunction or migration of any device component including leads, 
extensions, IPGs and accessories. 
• 
Procedure-related: Biological reaction (hematoma, infection, pain, etc.) as a result of the 
surgical procedure to implant the device. 
• 
Stimulation-related: Event known to be caused by stimulation from the device. Normally 
stimulation-related events resolve when the device is turned off or reprogrammed. 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than 
outlined below.  
Clinical Site 
Reporting timelines 
All Sites 
SAEs must be reported no later than 3 calendar days from the day the 
site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those 
outlined. 
 
The date the site staff became aware the event met the criteria of an SAE must be recorded in 
the source document.  
The Investigator will further report the SAE to the local IRB/EC according to the institution’s 
IRB/EC reporting requirements. 
Adverse events that are not serious will be reported to the Sponsor, as soon as possible after 
the occurrence of the event. 
Please reference Section 3 of this document for risk information and Section 9.3 for a complete 
list of adverse effects related to DRG Neurostimulation Systems. 
For unexpected failure modes or unexpected for all AEs, the site should follow their standard 
reporting practices for medical device reporting (MDR). As defined in 21 CFR 803, a MDR 
reportable event (or reportable event) is an event that device user facilities become aware of 
that reasonably suggests that a device has or may have caused or contributed to a death or 
serious injury. A device user facility must report deaths and serious injuries that a device has or 
may have caused or contributed to, establish and maintain AE files, and submit summary 
annual reports to FDA. 
 
The Investigator will assign degree of relatedness to the device for all SAEs and device, 
procedure and stimulation-related AEs based on NIH definitions as follows: 
 
Possibly Device/Procedure-Related: (must meet at least 2 criteria) 
• 
Has a reasonable temporal relationship to intervention, 
• 
Could not readily have been produced by the subject’s clinical state, 
• 
Could not readily have been due to environment or other interventions, 
• 
Follows a known pattern of response to intervention. 
Related to Device/Procedure: (must meet at least 3 criteria) 
• 
Has reasonable temporal relationship to intervention, 

 
 
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• 
Could not readily have been produced by the subject’s clinical state or have been due 
to environmental or other interventions 
• 
Follows a known pattern of response to intervention, 
• 
Disappears or decreases with reduction in dose or cessation of intervention. 
Additionally, AEs can be classified as unrelated if the causal relationship cannot be attributed to 
the device and/or procedure related. 
 
Additional information may be requested, when required, by the Sponsor in order to support the 
reporting of AEs to regulatory authorities. 
 
Anticipated AEs 
Possible risks to the subjects include both device- and procedural-based risks. Below is a list of 
the potential adverse effects associated with the implant and use of the Axium Neurostimulator 
System. 
 
Risks associated with any surgical procedure: abscess; cellulitis; excessive fibrotic tissue; 
wound dehiscence; wound, local or systemic infection; wound necrosis; edema; inflammation; 
foreign body reaction; hematoma; seroma; thrombosis; ischemia; embolism; thromboembolism; 
hemorrhage; thrombophlebitis; adverse reactions to anesthesia; hypertension; pulmonary 
complications; organ, nerve or muscular damage; gastrointestinal or genitourinary compromise; 
seizure, convulsion, or changes to mental status; complications of pregnancy including 
miscarriage and fetal birth defects; inability to resume activities of daily living; and death. 
 
Risks associated with system placement procedures: pain at the implant site, swelling; infection, 
cerebrospinal fluid (CSF) leakage, CSF fistula, epidural hemorrhage, bacterial meningitis, 
seroma, weakness, hematoma, tissue damage, nerve damage, sensory loss, spinal cord 
compression; and paralysis. Patient use of anticoagulation therapies may increase the risk of 
procedure-related complications, such as hematomas, which could produce paralysis.  
 
Risks associated with the use of the system: lead migration; INS migration; allergic response or 
tissue reaction to the implanted system material; hematoma or seroma at the implant site; skin 
erosion at the implant site; persistent pain at the INS and/or lead site, extension, or lead site; 
radicular chest wall stimulation; disturbed urination; dysesthesia; decubitus; headache; 
allodynia; hyperesthesia; premature battery depletion; loss of pain relief over time; escalating 
pain; clumsiness; numbness; temporary muscle activation; and uncomfortable stimulation or 
ineffective pain control caused by random failure of the system components or battery, changes 
in electrode position, loose electrical connections, lead or extension insulation breaches or 
fractures, lead retention, and inability to achieve the desired pain relief results. 
 
An additional risk to the subject is pain due to setting the stimulation parameters too high as a 
result of the placement and stimulation of the lead in the area of the DRG. 
 
Below is a list of the potential adverse effects associated with the implant and use of the DRG 
Neurostimulation System with Proclaim DRG IPG:  
• 
Unpleasant sensations or motor disturbances, including involuntary movement, 
caused by stimulation at high outputs (if either occurs, turn off IPG immediately) 

 
 
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• 
Undesirable changes in stimulation, which may be related to cellular changes in 
tissue around the electrodes, changes in electrode position                                 
• 
Changes in stimulation or reduced pain relief due to loose electrical connections  
• 
Changes in stimulation or reduced pain relief due to lead failure.  
• 
Stimulation in unwanted places (such as stimulation of the chest wall) 
• 
Lead migration, causing changes in stimulation or reduced pain relief 
• 
Epidural hemorrhage  
• 
Hematoma  
• 
Infection  
• 
Spinal cord compression 
• 
Paralysis from placement of a lead in the epidural space 
• 
Cerebrospinal fluid (CSF) leakage 
• 
Tissue damage or nerve damage 
• 
Paralysis, weakness, clumsiness, numbness, sensory loss below the level of the 
implant  
• 
Pain below the level of the implant 
• 
Pain or bleeding where the needle was inserted 
• 
Persistent pain at the electrode or IPG site 
• 
Escalating pain 
• 
Seroma (mass or swelling) at the implant site 
• 
Headache 
• 
Allergic or rejection response to device or implant materials 
• 
Implant migration 
• 
Skin erosion around the implant 
• 
Battery failure, leakage, or both 
• 
Hardware malfunction that requires replacing the neurostimulator 
• 
Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain 
• 
Formation of reactive tissue in the epidural space around the lead, which can cause 
delayed spinal cord compression and paralysis and requires surgical intervention 
(time to onset can range from weeks to many years after implant). 
Additional risks to the patients, as a result of the placement and stimulation of the lead in the 
area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too 
high. This may occur once the lead is in place and is connected to the neurostimulator and 
activated.  
 
Below is a list of the potential adverse effects associated with the implant and use of MR 
Conditional Neurostimulation devices that may occur in the MRI environment: 
 
• 
Lead electrode heating resulting in tissue damage or serious patient injury 
• 
IPG heating resulting in tissue damage in the implant pocket or patient discomfort or 
both 

 
 
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Clinical Investigational Plan  
 
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• 
Induced currents on leads resulting in overstimulation or shocking sensations 
• 
Damage to the IPG or leads causing the system to fail to deliver stimulation or 
causing the system to deliver overstimulation 
• 
Damage to the functionality or mechanical integrity of the IPG resulting in the inability 
to communicate with the IPG 
• 
Movement or vibration of the IPG or leads 
 
Subject Death 
All patient deaths that occur during this investigation must be reported to St. Jude Medical as 
soon as possible (per Section 9.2). It is the investigator’s responsibility to notify the IRB per the 
IRB policy. Should death occur, the investigator is required to record death information in the 
hospital records, and document the information on the case report form through the EDC 
system.  
 
Subject Death may be an outcome of an SAE.  
• 
Death is therefore related to an SAE: all efforts to obtain the SAE details should be 
made and the AE form must be completed or updated accordingly.  
• 
The subject’s death is an Early Conclusion of the subject’s participation in the study. 
Therefore, the investigator is requested to complete the Withdrawal form.  
 
Complaint Reporting 
A complaint is defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Complaints may be submitted from the time of 
consent through the end of the study.  
 
If a complaint involves an adverse device effect category or death as described in the protocol 
(Section 9.1-9.3), then the investigator shall notify the Sponsor by completing the adverse event 
or death case report form as applicable and must provide the Sponsor with all necessary 
documentation needed.  
 
If the complaint does not involve a reportable adverse event per protocol, the investigator 
should notify the SJM Product Surveillance Department through one of the methods listed below 
as soon as possible after becoming aware of a complaint. The following is the contact 
information for reporting complaints: via email at CCoordinators@abbott.com or by phone at 972-
309-8000. 
 
 DATA ANALYSIS 
The primary objective of this study is to demonstrate that the proportion of serious adverse 
effects (SAEs) at 12 months for subjects who receive a permanently implanted DRG stimulation 
system is lower than a pre-specified performance goal. The primary endpoint is the 12-month 
SAE rate from permanent implant until 12-month follow-up. XXXXX 
 

 
 
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Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
 
Primary Endpoint 
The hypothesis is stated as follows: 
H0: p ≥ 15.5% 
H1: p < 15.5% 
where p is the 12-month SAE rate for subjects who receive the permanent Axium or Proclaim 
DRG IPG (proportion of subjects who experience at least one SAE from permanent implant 
through 12-month follow-up). The hypothesis will be tested at the 5% significance level. The 
analysis population will include subjects who received the permanent Axium or Proclaim DRG 
IPG, who either have an SAE after permanent implant or complete the 12-month follow-up visit.  
The primary endpoint analysis will be conducted using Kaplan-Meier method on subjects who 
received the permanent Axium or Proclaim DRG IPG (primary analysis population). The serious 
adverse events (SAE) include adverse events which CEC adjudicates as serious events. The 12-
month SAE rate will be estimated using Kaplan-Meier method with a 95% upper confidence 
bound (UCB) estimated using log-log transformation. If the 95% UCB is less than the 15.5%, the 
null hypothesis will be rejected.  
XXXX. 
 
Secondary Endpoints 
10.2.1 Reduction in pain intensity (VAS) 
The endpoint will test whether subjects achieve a clinically relevant change (mean percentage 
reduction of at least 30%) in VAS score at 12 months from baseline.  Percentage change in VAS 
score is calculated within each subject as:  
% Change in VAS score = (VAS at baseline – VAS at 12-month)/VAS at baseline*100% 
The following hypothesis will be tested: 
H0: Mean % Change in VAS score ≤ 30%   
H1: Mean % Change in VAS score > 30%  
The hypothesis will be tested at the 5% significance level. The analysis will be carried out by 
calculating the 95% lower confidence bound (LCB) on the mean % Change in VAS from baseline 
to 12-month visit based on a t-distribution.  If the 95% LCB is greater than 30.0%, the null 
hypothesis is rejected.  The analysis population for this secondary endpoint will include subjects 
who complete both baseline and 12-month VAS scales, irrespective of IPG types. 
10.2.2 Change in Physical Function (PROMIS Physical Function score) 
The endpoint will test whether there is a change in mean PROMIS-29 Physical Function domain 
scores at 12 months from baseline. Change in PROMIS-29 Physical Function domain score is 
calculated as: 
Change in PROMIS-29 Physical Function domain score = (PROMIS-29 Physical 
Function domain score at 12-Month – PROMIS-29 Physical Function domain score at 

 
 
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Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
Baseline) 
The following hypothesis will be tested: 
H0: Change in PROMIS-29 Physical Function domain score ≤ 0   
H1: Change in PROMIS-29 Physical Function domain score > 0  
The hypothesis will be tested at the 5% significance level.  The analysis will be carried out by 
calculating the 95% LCB on the mean change in PROMIS-29 Physical Function domain score 
from baseline to 12-month visit based on a t-distribution.  If the 95% LCB is greater than 0, the null 
hypothesis is rejected. The analysis population for this secondary endpoint will include subjects 
who complete both the baseline and 12-month PROMIS-29 Profile, irrespective of IPG types.  
10.2.3 Change in Global Health (PROMIS Global Health score) 
The endpoint will test whether there is a change in mean PROMIS Global Health Score from 
baseline to 12 months. Change in PROMIS Global Health Sore is calculated as: 
Change in PROMIS Global Health Score = (PROMIS Global Health Score at 12-Month – 
PROMIS Global Health Score at Baseline) 
The following hypothesis will be tested: 
H0: Change in PROMIS Global Health Score ≤ 0   
H1: Change in PROMIS Global Health Score > 0 
The hypothesis will be tested at the 5% significance level.  The analysis will be carried out by 
calculating the 95% LCB on the mean change in PROMIS Global Health Score from baseline to 
12-month visit based on a t-distribution.  If the 95% LCB is greater than 0, the null hypothesis is 
rejected. The analysis population for this secondary endpoint will include subjects who complete 
both baseline and 12-month PROMIS Global Health questionnaire, irrespective of IPG types.  
 
Descriptive Endpoints 
The following descriptive endpoints will be reported:  
• 
Proportion of subjects with device, procedure or stimulation-related SAEs and non-
SAEs among subjects who receive the permanent implant  
• 
Proportion of subjects who have AEs related to the trial implant procedure among 
subjects who fail the trial neurostimulator phase 
• 
Summary of procedure-related SAEs and non-SAEs by implanter experience 
• 
Change from baseline to 1, 3, and 6 months post-permanent implant for overall pain 
intensity measured using the Visual Analog Scale (VAS) 
• 
Change from baseline to 1, 3, and 6 months post-permanent implant for physical 
function measured using the PROMIS-29 Profile  
• 
Change from baseline to 1, 3, and 6 months post-permanent implant for quality of life 
measured using the PROMIS Global Health Scale 
• 
Change from baseline to 1, 3, 6 and 12 months post-permanent implant for 
neuropathic pain measured using the Neuropathic Pain Scale (NPS) 

 
 
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Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
• 
Change from baseline to 1, 3, 6 and 12 months post-permanent implant for sleep 
disturbance, anxiety, depression, fatigue, ability to participate in social roles and 
activities, pain interference and pain intensity measured using the PROMIS-29 Profile  
• 
Patient Global Impression of Change (PGIC) at 1, 3, 6 and 12 months post-
permanent implant 
The analysis population for these descriptive endpoints will include subjects with available 
data. 
 
Additional Data 
The following additional data, including but not limited to: percentage of subjects achieving at least 
a 30% and 50% pain reduction, demographics, paresthesia coverage and intensity, subject 
satisfaction, programming parameters, implant procedure information, and system information will 
be summarized and reported. 
 
Sample Size 
XXXX 
 
Subgroup Analysis 
Primary and secondary endpoints will be analyzed by comparing subjects who had previously 
failed SCS for lack of pain relief (i.e. did not receive > 50% pain relief) to those who had not 
previously failed SCS (i.e. naïve subjects or those who failed SCS due to reasons other than pain 
relief). 
Primary, secondary and descriptive endpoints will be analyzed for two distinct cohorts based upon 
the type of IPG received at permanent implant (Axium or Proclaim). 
 
 
Interim Analysis 
There are no planned interim analyses intended to test hypotheses or modify the study. 
However, the safety endpoints will be descriptively summarized annually in the progress report 
until the study is closed. The following safety endpoints will be summarized for each interim 
analysis:  
 
• 
12-month SAE rate for permanent implants.  
• 
Proportion of subjects with device, procedure or stimulation-related SAEs and non-SAEs 
among subjects who receive the permanent implant 
• 
Proportion of subjects who have AEs related to the trial implant procedure among 
subjects who fail the trial neurostimulator phase 
• 
Summary of procedure-related SAEs and non-SAEs by implanter experience 
 
 
The Treatment of Missing, Unused, or Spurious Data, Including Drop-Outs and 
Withdrawals  
Analyses of each endpoint will be performed in subjects who provide complete data for each 
endpoint. Subject accountability for enrolled subjects will be performed prior to analyses of the 
primary and secondary endpoints.  There are no plans to perform imputations for missing data, 

 
 
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Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
subject dropouts or withdrawals. If spurious data are discovered, these data will be excluded 
from analyses. Reasons for exclusion of any data from analyses will be summarized.     
 
The Exclusion of Particular Information for the Testing of the Hypothesis 
There is no intent to exclude particular information for the testing of hypotheses.  
 
 SUBJECT RECRUITMENT 
Sites will be provided with IRB-approved laminated cards that list the study inclusion criteria for 
easy identification of eligible subjects. All sites are expected to develop and implement their own 
site-specific subject recruitment plan. Study recruitment materials, such as IRB-approved 
posters and brochures, will be provided to the site upon request. 
XXXXX 
 SUBJECT RELOCATION 
If a subject moves from the geographic catchment area of their investigator, then St. Jude 
Medical (SJM) will first attempt to place the subject with another investigator in the study. If it is 
not possible to place the subject with another investigator, the subject will be considered lost to 
follow up per the lost to follow up definition in Section 13 below.  
 
 SUBJECT WITHDRAWAL OR DISCONTINUATION 
Subjects must be informed about their right to withdraw from the study at any time and for any 
reason without sanction, penalty or loss of benefits to which the subject is otherwise entitled and 
withdrawal from the study will not jeopardize their future medical care or relationship with the 
investigator. Subjects will be asked to specify the reason for the termination, but have the right 
not to answer. 
 
The subject’s future care will not be influenced by a decision, voluntary or otherwise, to 
withdraw from the study. All reasonable efforts should be made to retain the subject in the 
clinical study until completion of the study. 
 
Reasons for subject’s withdrawal include, but are not limited to: 
• 
Subject refuses to continue participating in the study 
• 
Subject is deceased (cause must be documented) 
• 
Subject’s non-compliance 
• 
Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow up visits 
but has not explicitly requested to be withdrawn from the clinical study. Site personnel 
should at all times make all reasonable efforts to locate and communicate with the 
subject in order to achieve subject compliance to the scheduled follow up visits: 
1. A subject will be considered ‘Lost to Follow Up’ after a minimum of 2 phone 
calls of a physician or delegate at the investigational site to the subject or 
contact. These 2 phone calls need to be documented in the subject’s medical 
records. 
 

 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
2. If these attempts are unsuccessful, a letter should be sent to the subject’s last 
known address or the subject’s general practitioner (GP) and a copy of this 
letter should be maintained in the subject’s medical records. 
 
Note: If a subject misses one or more of the scheduled follow up visits (inclusive of the assigned 
visit windows) without being lost to follow-up this will be considered as a missed visit. The 
subject may, therefore, still return for subsequent visits and will not be withdrawn from the study. 
 
If there is a potential withdrawal in the study, please contact a member of the study team to see 
if there is anything that can be done to keep the subject in the study.  
 
An analysis will be performed to compare demographics and key clinical characteristics for the 
subjects who have withdrawn and those who continue to be enrolled in the study. This analysis 
will be reported in the annual progress reports.  
 
 COMPLIANCE TO CIP 
 
Adherence to the CIP 
A deviation is defined as an event where the clinical investigator, site personnel, sponsor or 
sponsor representative did not conduct the clinical study according to the Clinical Investigational 
Plan, IRB requirements or the Investigator Agreement. The investigator is not allowed to deviate 
from the CIP, except as specified under emergency circumstances.  
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, 
safety and well-being of subjects, since the non-compliance exposes subjects to unreasonable 
risks. For example, failure to adhere to the inclusion/exclusion criteria: these criteria are 
specifically defined by the Sponsor to exclude subjects for whom the device is not beneficial and 
the use involves unreasonable risks. This may be considered failure to protect the rights, safety 
and well-being of the consented subject. Similarly, failure to perform safety assessments 
intended to detect AEs may be considered failure to protect the rights, safety and well-being of 
the consented subject. Investigators should seek minimization of such risks by adhering to the 
CIP. 
 
Simultaneously, in the event that adhering to the CIP might expose the subject to unreasonable 
risks, the investigator is also required to protect the rights, safety and well-being of the subject 
by intentionally deviating from the requirements of the CIP, so that subjects are not exposed to 
unreasonable risks.  
 
It is the responsibility of the investigator to provide adequate medical care to a subject 
consented for participation in a study. 
 
Regulations require that the Investigator maintain accurate, complete, and current records, 
including documents showing the date of and reason for every deviation from the Clinical 
Investigational Plan.  
 
Regulations require Investigators obtain approval from St. Jude Medical and the IRB [as 
required] before initiating changes in or deviations from the protocol, except when necessary to 
protect the life or physical well-being of a subject in an emergency. Under emergency 

 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
circumstances, deviations from the CIP to protect the rights, safety and well-being of human 
subjects may proceed without prior approval of the sponsor and the IRB. Such deviations shall 
be documented and reported to the sponsor and the IRB as soon as possible, but no later than 
5 working days. 
 
Prior approval must be requested when the Investigator anticipates, contemplates, or makes a 
conscious decision to depart from the CIP, except when unforeseen circumstances are beyond 
the investigator’s control (e.g. a subject who fails to attend a scheduled follow-up visit, a subject 
is too ill to perform a CIP-required test, etc.). All deviations, including those beyond the 
investigator’s control, must be reported to the St. Jude Medical as soon as possible and to 
appropriate regulatory authorities in specified timelines (if appropriate). The Investigator is 
required to adhere to local regulatory requirements for reporting deviations to IRB. 
 
Investigator will notify St. Jude Medical and the reviewing IRB within 5 working days of: 
• 
Any deviation to protect the life or physical well-being of a subject in an emergency 
• 
Any failure to obtain informed consent 
 
Repeated and Serious Non-Compliance 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined 
by the Sponsor, a Clinical Research Associate or clinical representative will attempt to secure 
compliance by one or more of the following actions: 
• 
Visiting the investigator 
• 
Contacting the investigator by telephone 
• 
Contacting the investigator in writing 
• 
Retraining of the investigator 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or 
any other conditions of the clinical study, the Sponsor will either secure compliance or, at its 
sole discretion, terminate the investigator’s participation in the clinical study. 
 
 AMENDMENTS TO CLINICAL INVESTIGATIONAL PLAN 
Study related documents such as, the CIP, Informed Consent form and other subject 
information, or other clinical study documents will be amended as needed. Proposed 
amendments to the CIP will be agreed upon between the Sponsor and the coordinating 
investigator (if applicable). The amendment will identify the changes made and the reason for 
the changes. The amendments to the CIP and the subject’s Informed Consent will be notified to, 
or approved by, the IRB and regulatory authorities, if required.  
 
Any amendment affecting the subject requires that the subject be informed of the changes and 
a new consent be signed and dated by the investigator at the subject’s next follow up. 
 INVESTIGATION SUSPENSION OR TERMINATION 
The Sponsor reserves the right to stop the study at any stage, with appropriate written notice to 
the investigator. Possible reasons for early termination of the study by the sponsor, either at 
local, national or international level, may include, but are not limited to: 
• 
The device / therapy fails to perform as intended 

 
 
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Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
• 
Occurrence of SAE which cannot be prevented in future cases 
• 
Sponsor’s decision 
• 
Request from Regulatory bodies 
• 
Request of IRB  
• 
Concern for subject safety and welfare 
• 
Failure to secure subject Informed Consent prior to any investigational activity 
• 
Repeated non-compliance with this CIP or the Clinical Trial Agreement 
• 
Inability to successfully implement this CIP 
• 
Falsification of data, or any other breach of ethics or scientific principles 
• 
Loss of or unaccounted use of investigational device inventory 
The study will be terminated according to applicable regulations. The investigator may also 
discontinue participation in the clinical study with appropriate written notice to the Sponsor. 
Should either of these events occur, the investigator will return all documents to the sponsor; 
provide a written statement as to why the premature termination has taken place and notify the 
IRB. Follow-up for all consented subjects will be as per CIP requirements. An Investigator, IRB 
or regulatory authority may suspend or prematurely terminate participation in a clinical study at 
the investigational sites for which they are responsible.  
 
If suspicion of an unacceptable risk to subjects arises during the clinical study or when so 
instructed by the IRB or regulatory authority, St. Jude Medical may suspend the clinical study as 
appropriate while the risk is assessed. St. Jude Medical will terminate the clinical study if an 
unacceptable risk is confirmed.  
 
St. Jude Medical will consider terminating or suspending the participation of a particular 
investigational site or investigator in the clinical study if monitoring or auditing identifies serious 
or repeated deviations on the part of an investigator.  
 
If suspension or premature termination occurs, the terminating party will justify its decision in 
writing and promptly inform the other parties with whom they are in direct communication. The 
Principal Investigator and St. Jude Medical will keep each other informed of any communication 
received from IRB or regulatory authority.  
 
If for any reason St. Jude Medical suspends or prematurely terminates the study at an individual 
investigational site, St. Jude Medical will inform the responsible regulatory authority, as 
appropriate, and ensure that the IRBs are notified, either by the Investigator or by St. Jude 
Medical. If the suspension or premature termination was in the interest of safety, St. Jude 
Medical will inform all other Principal Investigators.  
 
If suspension or premature termination of enrollment occurs, St. Jude Medical will remain 
responsible for providing resources to fulfill the obligations from the CIP and existing 
agreements for following up the subjects consented for participation in the clinical study, and the 
Investigator or authorized designee will promptly inform the consented subjects at his/her 
investigational site, if appropriate. 
 

 
 
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Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
 RESUMING THE STUDY AFTER TEMPORARY SUSPENSION 
When St. Jude Medical concludes an analysis of the reasons for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, St. Jude Medical will 
inform the Investigators, IRB, or regulatory authority, where appropriate, of the rationale, providing 
them with the relevant data supporting this decision. Concurrence will be obtained before the 
clinical study resumes from the IRB or regulatory authority where appropriate. If subjects have 
been informed of the suspension, the Principal Investigator or authorized designee will inform 
them of the reasons for resumption. 
 
 ADMINISTRATIVE REQUIREMENTS AND QUALITY ASSURANCE 
 
Study Investigators 
The study will be conducted by qualified investigators who have been evaluated and have 
completed the required training related to implant and use of DRG Neurostimulation Systems. 
 
Institutional Review Board (IRB) 
Before study enrollment can begin, the Investigator must provide the Sponsor with a copy of the 
approval notice for the protocol and informed consent forms, signed by the committee 
Chairperson or designee. An Investigator shall report to the Sponsor, within 5 working days, a 
withdrawal of approval by the reviewing IRB of the Investigator’s part of an investigation. 
 
Informed Consent 
Written Informed Consent will be obtained from all subjects before any study-related procedures 
are performed. All potential subjects must be properly informed as to the purpose of the study 
and the potential risks and benefits known or that can be reasonably predicted or expected. The 
Investigator will retain the original copy of the Informed Consent Form signed by the subject and 
a duplicate will be provided to the subject. Only the consent form approved by the IRB should 
be used. 
 
 DATA MANAGEMENT 
The Sponsor will be responsible for the data handling. The sponsor and/or its affiliates will be 
responsible for compiling and submitting all required reports to governmental agencies. 
 
St. Jude Medical respects and protects personally identifiable information collected or 
maintained for this clinical trial. The privacy of each subject and confidentiality of his/her 
information will be preserved in reports and when publishing any data. Confidentiality of data will 
be observed by all parties involved at all times throughout the clinical trial. All data will be 
secured against unauthorized access. 
 
Data will be captured in a validated electronic database management system hosted by St. 
Jude Medical. Only authorized site personnel will be permitted to enter data into the electronic 
data capture (EDC) system deployed by St. Jude Medical. An electronic audit trail will be used 
to track any subsequent changes of the entered data. 

 
 
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Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
 
Data Management Plan (DMP) 
A detailed Data Management Plan will be established to ensure consistency of the data. This 
document will include procedures used for data review, database cleaning, and issuing and 
resolving data queries. If appropriate, the DMP may be updated throughout the study duration. 
All revisions will be tracked and document controlled. 
Data will be captured in a validated electronic database management system hosted by St. 
Jude Medical. Only authorized site personnel will be permitted to enter data into the electronic 
data capture (EDC) system deployed by St. Jude Medical. An electronic audit trail will be used 
to track any subsequent changes of the entered data. 
XXXXX 
 MONITORING 
It is the responsibility of St. Jude Medical as the sponsor of the study to ensure the study is 
conducted, recorded, and reported according to the approved protocol, subsequent 
amendment(s), applicable regulations, and guidance documents. Monitoring will be conducted 
according to the St. Jude Medical Clinical Monitoring standard operating procedure. 
 
Prior to beginning the study, St. Jude Medical will contact the investigator or designee to 
discuss the study and data requirements. A St. Jude Medical monitor will periodically review the 
subject records and associated source documents. The investigator shall make subject and 
study records available to the clinical monitor for monitoring.  
 
Centralized monitoring will occur through routine internal data review. This monitoring is designed 
to identify missing and inconsistent data, data outliers, and potential protocol deviations that may 
be indicative of site non-compliance. On-site monitoring may occur at the discretion of the 
Sponsor.  
 REGULATORY INSPECTIONS 
The investigator and/or delegate should contact St. Jude Medical immediately upon notification 
of a governmental agency inspection at the site. A clinical monitor or designee will assist the 
investigator and/or delegate in preparing for the audit. 
 
An investigator, or any person acting on behalf of such a person with respect to the study, will 
permit authorized governmental agency employees, at reasonable times and in reasonable 
manner, to inspect and copy all records relating to the study. 
 
An investigator will permit authorized governmental agency employees to inspect and copy 
records that identify subjects, upon notice that governmental agency has reason to suspect that 
adequate informed consent was not obtained, or that reports required to be submitted by the 
investigator, to the Sponsor or IRB have not been submitted or are incomplete, inaccurate, false 
or misleading. 
 
 DOCUMENT RETENTION 
St. Jude Medical and the Principal Investigators will maintain the clinical study documents as 
required by St. Jude Medical, Inc. and applicable regulatory requirements. They will take 
measures to prevent accidental or premature destruction of these documents.  The Principal 

 
 
Study Document No: SJM-CIP-10113 Ver. E 
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Clinical Investigational Plan  
 
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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
Investigator or St. Jude Medical may transfer custody of records to another person/party and 
document the transfer at the investigational site or at St. Jude Medical’s facility. 
 
These documents must be retained by the investigational site for a period of 2 years after 
clinical study conclusion and made available for monitoring or auditing by St. Jude Medical’s 
representative or representatives of the FDA and other applicable regulatory agencies. The 
Investigator must ensure the availability of source documents from which the information was 
derived. 
 
 DEVIATIONS FROM THE INVESTIGATION PLAN 
All deviations from the Investigational plan will be recorded on a worksheet and in the EDC 
system. In accordance with 21 CFR 812.150(a)(4), an Investigator shall notify the Sponsor and 
the reviewing IRB of any deviation from the investigational plan to protect the life or physical 
well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in 
no event later than 5 working days after the emergency occurred. Except in such an emergency, 
prior approval by the Sponsor is required for changes in or deviations from a plan, and if these 
changes or deviations may affect the scientific soundness of the plan or the rights, safety, or 
welfare of human subjects, FDA and IRB in accordance with 812.35(a) also is required. 
 
 CLINICAL EVENTS COMMITTEE (CEC) 
A Clinical Events Committee (CEC) will be responsible for providing an independent review and 
adjudication of all subject deaths and adverse events. The CEC will review adverse events and 
determine device and/or procedure relatedness and whether serious or not (ADEs, SADEs, and 
SAEs). The CEC will base their final adjudication on the information provided on the case report 
forms, medical records, and their clinical knowledge and experience. The committee will consist 
of a minimum of three (3) members, comprised of pain specialists with experience in medical 
device implants/studies. The CEC will meet on an as-needed basis, at a minimum twice a year, 
to assess individual events in the study.XXXXXX 
 PUBLICATION POLICY 
The results of the clinical study will be submitted for publication, regardless of the outcome. A 
‘Publication Agreement’ will be signed between the Principal Investigator and the Sponsor either 
as a separate Publication Agreement or within the Clinical Trial Agreement. The International 
Committee of Medical Journal Editors (ICMJE) guidelines on publication will be followed 
(www.icmje.org). This study will be posted on ClinicalTrials.gov and results will be posted on 
ClinicalTrials.gov as required. 
 

 
 
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Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
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disclosed or used without the express written consent of St. Jude Medical 
 
 BIBLIOGRAPHY 
1. “Front Matter.”Relieving Pain in America. A blueprint for transforming prevention, care, 
education, and research. Washington, DC: The National Academies Press, 2011. 
2. Manchikanti L, Singh V, Pampati V, Smith HS, Hirsch JA. Analysis of growth of 
interventional techniques in managing chronic pain in the Medicare population: a10-year 
evaluation from 1997 to 2006. Pain Physician. 2009;12:9–34. 
3. de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. (2009). Effect and 
safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. 
J Diabetes Complications. 2009;23(1):40-5. 
4. Duyvendak W. Spinal cord stimulation with a dual quadripolar surgical lead placed in 
general anesthesia is effective in treating intractable low back pain and leg pain. 
Neuromodulation. 2007;10(2):113-119. 
5. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical 
management for neuropathic pain: a multicentre randomised controlled trial in patients with 
failed back surgery syndrome. Pain. 2007;132(1-2):179-188. 
6. Leveque JC, Villavicencio AT, Bulsara K, Rubin L, Gorecki J. Spinal cord stimulation for 
failed back surgery syndrome. Neuromodulation. 2001;4(1):1-9. 
7. North RB, Kidd DH, Olin J, et al. Spinal cord stimulation for axial low back pain: a 
prospective, controlled trial comparing dual with single percutaneous electrodes. Spine. 
2005;30(12):1412-1418.  
8. Forouzanfar T, Kemler MA, Weber WE, Kessels AG, van Kleef M. Spinal cord stimulation in 
complex regional pain syndrome: cervical and lumbar devices are comparably effective. Br J 
Anaesth. 2004; 92(3):348-353. 
9. Harke H, Gretenkort P, Ladleif HU, Rahman S. Spinal cord stimulation in sympathetically 
maintained complex regional pain syndrome type I with severe disability. A prospective 
clinical study. Eur J Pain. 2005;9(4):363-73. 
10. Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, & van Kleef M. Effect of 
spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final 
follow-up of patients in a randomized controlled trial. J Neurosurg. 2008;108(2):292-298 
11. Katayama Y, Yamamoto T, Kobayashi K, Kasai M, Oshima H, & Fukaya C. Motor cortex 
stimulation for phantom limb pain: comprehensive therapy with spinal cord and thalamic 
stimulation. Stereotact Funct Neurosurg. 2001;77(1-4):159-162. 
12. Amann W, Berg P, Gersbach P, Gamain J, Raphael JH, & Ubbink DT. Spinal cord 
stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of 
the European Peripheral Vascular Disease Outcome Study (SCS-EPOS). Eur J Vasc 
Endovasc Surg. 2003; 26(3), 280-286. 
13. Kumar A, Felderhof C, & Eljamel MS. Spinal cord stimulation for the treatment of refractory 
unilateral limb pain syndromes. Stereotact Funct Neurosurg. 2003;81(1-4):70-74. 
14. Harke H, Gretenkort P, Ladleif HU, Koester P, & Rahman S. Spinal cord stimulation in 
postherpetic neuralgia and in acute herpes zoster pain. Anesth Analg. 2002;94(3):694-700. 
15. Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, & Cohen SP. Spinal Cord 
Stimulation for Patients with Failed Back Surgery Syndrome: A Systematic Review. Pain 
Physician. 2009;12(2):379-397. 
16. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment 
outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105-
21. 
17. Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to 
neuropathic pain: the Neuropathic Pain Scale. Neurology. 1997;48(2):332-8. 

 
 
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Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
18. Fishbain DA, Lewis JE, Cutler R, Cole B, Rosomoff HL, Rosomoff RS. Can the neuropathic 
pain scale discriminate between non-neuropathic and neuropathic pain? Pain 
Med. 2008;9(2):149-60. 
19. Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, 
Choi S, Cook K, DeVellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Pilkonis P, Revicki 
D, Rose M, Weinfurt K, Hays R, Lai JS, on behalf of the PROMIS Cooperative Group. The 
Patient Reported Outcomes Measurement Information System (PROMIS) developed and 
tested its first wave of adult self-reported health outcome item banks: 2005-2008. Journal of 
Clinical Epidemiology. 2010;63(11): 1179-94. 
20. Stone AA, Broderick JE, Junghaenel DU, Schneider S, Schwartz JE. PROMIS fatigue, pain 
intensity, pain interference, pain behavior, physical function, depression, anxiety, and anger 
scales demonstrate ecological validity. Journal of Clinical Epidemiology. 2015;doi: 
10.1016/j.jclinepi.2015.08.029.  
21. Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on 
subjective outcome measures. J Manipulative Physiol Ther. 2004;27(1):26-35. 
22. Amirfeyz R1, Pentlow A, Foote J, Leslie I. Assessing the clinical significance of change 
scores following carpal tunnel surgery. Int Orthop. 2009;33(1):181-5. 
23. Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain measures: what do the NRS, 
VAS, VRS, and FPS-R measure? Scand J Pain. 2018;18(1):99-107. 
24. Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating 
scales. Pain. 2011;152(10):2399-404.  
 
 
 
 

 
 
Study Document No: SJM-CIP-10113 Ver. E 
Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
APPENDIX A: ABBREVIATIONS 
 
 
Abbreviation 
Term 
AE 
CEC 
CIP 
CRPS 
DMP 
DRG 
eCRF 
EDC 
ICMJE 
IPG 
IRB 
ISO 
MP 
NA 
PG 
RDC 
SAE 
SJM 
TENS 
Adverse Event 
Clinical Events Committee 
Clinical Investigational Plan 
Complex Regional Pain Syndrome 
Data Management Plan 
Dorsal Root Ganglion Stimulation 
Electronic Case Report Form 
Electronic Data Capture 
International Committee of Medical Journal Editors 
Implantable Pulse Generator 
Institutional Review Board 
International Organization for Standardization 
Monitoring Plan 
Not Applicable 
Pulse Generator 
Remote Data Capture 
Serious Adverse Event 
St. Jude Medical 
Transcutaneous Electrical Nerve Stimulation 
 
 

 
 
Study Document No: SJM-CIP-10113 Ver. E 
Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
Page 43 of 44 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
APPENDIX B: CIP REVISION HISTORY 
XXXXX 
APPENDIX C: DECLARATION OF HELSINKI 
The most current version of the document will be followed. 
 
 

 
 
Study Document No: SJM-CIP-10113 Ver. E 
Study Name: TARGET (DRG) Post-Approval Study 
Clinical Investigational Plan  
 
Page 44 of 44 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
APPENDIX D: LIST OF CLINICAL INVESTIGATION SITES AND IRB 
A list of Clinical Investigational sites and IRB will be kept under a separate cover and is 
available upon request.  
 
APPENDIX E: SAMPLE INFORMED CONSENT 
Sample Informed Consent form will be kept under a separate cover and is available upon 
request.  
 
APPENDIX F: CASE REPORT FORMS 
Final Case Report Forms will be kept under a separate cover and are available upon request.  
 
APPENDIX G: INSTRUCTIONS FOR USE 
 
IFUs will be kept under a separate cover and are available upon request.