Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
Phase: NA
Conditions: Chronic Pain, Intractable Pain
Sponsor: Abbott Medical Devices

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 1 of 44 
 
 
TRIUMPH 
MulTi-center pRospectIve stUdy deterMining the sustainability of 
Pain relief and psychosocial and functional responses wHen 
utilizing a multiple waveform enabled neurostimulator 
 
CRD_836 
Study Document No:  SJM-CIP-10145 
Version E 
Date:  19 NOV 2018 
Clinical Investigation Plan (CIP) 
 
 
Sponsor  
 
 
Abbott 
 
 
 
 
The Corporate Village 
 
 
 
 
Da Vincilaan 11- box F1 
 
 
 
 
1935 Zaventem  
Belgium 
 
 
 
 
 
Abbott 
 
 
 
 
6901 Preston Road 
 
 
 
 
Plano, TX 75024 USA 
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 2 of 44 
 
 
 
 
 
 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 3 of 44 
 
Table of Contents 
 
1 
Introduction............................................................................................................................................. 6 
2 
Background and Justification for Clinical Investigation .......................................................................... 6 
3 
Device(s) Under Investigation ................................................................................................................ 8 
 
Identification and Description of the Devices under investigation ................................................. 8 
3.1.1 
Device Description and Intended Purpose .............................................................................. 11 
3.1.2 
Device Handling and Storage .................................................................................................. 12 
4 
Clinical Investigation Design ................................................................................................................ 12 
 
Clinical Investigation Design ....................................................................................................... 12 
 
Objectives .................................................................................................................................... 12 
4.2.1 
Primary Objectives .................................................................................................................. 12 
4.2.2 
Secondary Objectives.............................................................................................................. 12 
 
Endpoints ..................................................................................................................................... 12 
4.3.1 
Primary Endpoint ..................................................................................................................... 12 
4.3.2 
Secondary Endpoint ................................................................................................................ 13 
4.3.3 
Demographic/Baseline Characteristic and Descriptive Endpoint(s) ........................................ 13 
 
Study Population ......................................................................................................................... 14 
4.4.1 
Inclusion Criteria ...................................................................................................................... 14 
4.4.2 
Exclusion Criteria ..................................................................................................................... 14 
5 
Procedures ........................................................................................................................................... 14 
 
Informed Consent Process .......................................................................................................... 14 
 
Point of Enrollment ...................................................................................................................... 15 
 
Scheduled Procedures ................................................................................................................ 15 
5.3.1 
Baseline ................................................................................................................................... 15 
5.3.2 
Trial System Implant ................................................................................................................ 16 
5.3.3 
End of Trial System Evaluation ............................................................................................... 16 
5.3.4 
Permanent System Implant ..................................................................................................... 17 
5.3.5 
3-Month Follow-up Visit ........................................................................................................... 17 
5.3.6 
6-Month Follow-up Visit ........................................................................................................... 17 
5.3.7 
12-Month Follow-up Visit ......................................................................................................... 18 
5.3.8 
18-Month Follow-up Visit ......................................................................................................... 18 
5.3.9 
24-Month Follow-up Visit ......................................................................................................... 18 
5.3.10 
MRI information (if applicable) ............................................................................................. 19 
5.3.11 
Death (if applicable), Revisions, Replacements or Explants (Additional Surgery).............. 19 
 
Patient Reported Outcome (PRO) Measures .............................................................................. 19 
5.4.1 
EuroQol 5- Dimensions Questionnaire (EQ5D) (EuroQol Group, 2009) ................................. 20 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 4 of 44 
 
5.4.2 
Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, & Pivik, 1995) ...................................... 20 
5.4.3 
State-Trait Anxiety Inventory for Adults (Spielberger, 1968) ................................................... 20 
5.4.4 
Patient Health Questionnaire-9 (PHQ-9) (Spitzer, Williams & Kroenke et. al) ........................ 20 
5.4.5 
Tampa Scale for Kinesiophobia (TSK) (Woby et al, 2005) ..................................................... 20 
5.4.6 
Medical Outcome Study (MOS) Sleep Scale (Hays & Stewart, 1992) .................................... 20 
5.4.7 
Patient-Reported Outcome Measure Information System (PROMIS) Physical Function – 
Short Form Version 1.2 ........................................................................................................................ 21 
5.4.8 
Pain Numerical Rating Score (NRS) ....................................................................................... 21 
5.4.9 
Pain Location ........................................................................................................................... 21 
5.4.10 
Stimulation Assessment ...................................................................................................... 21 
5.4.11 
Patient Global Impression of Change (PGIC) (Hurst & Bolton, 2004) ................................ 21 
 
Unscheduled Visits ...................................................................................................................... 21 
 
Study Flow Chart ......................................................................................................................... 22 
 
Description of Activities Performed by Sponsor Representatives ............................................... 24 
 
Subject Study Completion ........................................................................................................... 24 
 
Subject Withdrawal ...................................................................................................................... 25 
6 
Statistical Considerations ..................................................................................................................... 25 
6.1.1 
Primary Endpoint ..................................................................................................................... 25 
6.1.2 
Secondary Endpoints .............................................................................................................. 25 
6.1.3 
Demographic/Baseline Characteristic and Descriptive Endpoints .......................................... 26 
6.1.4 
Missing Data ............................................................................................................................ 27 
6.1.1 
Subgroup Analysis ................................................................................................................... 27 
 
Justification of Clinical Investigation Design ............................................................................... 28 
 
Overall Sample Size .................................................................................................................... 28 
 
Timing of Analysis ....................................................................................................................... 28 
 
Interim Analysis ........................................................................................................................... 28 
 
Statistical Criteria for Termination ............................................................................................... 28 
 
Deviations from Statistical Plan ................................................................................................... 28 
7 
Risks and Benefits ............................................................................................................................... 28 
 
Risks Associated with the Clinical Study Device ......................................................................... 28 
7.1.1 
Anticipated Adverse Device Effects ........................................................................................ 28 
7.1.2 
Risks Associated with Clinical Investigation Assessments ..................................................... 29 
 
Anticipated Benefits ..................................................................................................................... 30 
 
Risk-to-Benefit Rationale ............................................................................................................. 30 
8 
Requirements for Investigator Records and Reports ........................................................................... 30 
 
Deviations from CIP..................................................................................................................... 30 
 
Safety Reporting .......................................................................................................................... 30 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 5 of 44 
 
8.2.1 
Subject Death .......................................................................................................................... 31 
8.2.2 
Complaints ............................................................................................................................... 31 
 
Source records ............................................................................................................................ 32 
 
Records Retention ....................................................................................................................... 32 
9 
Clinical Data Handling .......................................................................................................................... 32 
 
Protection of Personally Identifiable Information ......................................................................... 32 
 
Data Management Plan ............................................................................................................... 32 
 
Document and Data Control ........................................................................................................ 33 
9.3.1 
Traceability of Documents and Data ....................................................................................... 33 
9.3.2 
Recording Data ........................................................................................................................ 33 
10 Monitoring............................................................................................................................................. 33 
11 Compliance Statement ......................................................................................................................... 33 
 
Statement of Compliance ............................................................................................................ 33 
 
Quality Assurance Audits and Regulatory Inspections ............................................................... 33 
 
Repeated and Serious Non-Compliance ..................................................................................... 34 
12 Suspension or Premature Termination of the Clinical Investigation .................................................... 34 
13 Clinical Investigation Conclusion ......................................................................................................... 34 
14 Publication Policy ................................................................................................................................. 35 
15 Reporting Results on ClincalTrials.gov Website .................................................................................. 35 
Appendix A: ABBREVIATIONS ................................................................................................................... 36 
Appendix B: CIP Revision History ............................................................................................................... 37 
Appendix C: Definitions ............................................................................................................................... 40 
Appendix D: Bibliography ............................................................................................................................ 41 
Appendix E: Case Report Form .................................................................................................................. 43 
Appendix F: Sample Informed Consent ...................................................................................................... 44 
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 6 of 44 
 
1 
Introduction 
This document is a clinical investigation plan (CIP) to evaluate the sustainability of pain control utilizing a 
multiple-waveform enabled neurostimulator in patients with chronic, intractable pain of the trunk and/or 
limbs. This clinical investigation is sponsored by Abbott (formerly St. Jude Medical) and will be conducted 
in accordance with this CIP.  
2 
Background and Justification for Clinical Investigation 
Spinal cord stimulation (SCS) is a minimally invasive and reversible procedure in which electrical leads are 
placed into the epidural space, applying stimulation to the large myelinated fibers of the dorsal column. 
SCS has been used successfully to treat a variety of pain conditions including, diabetic neuropathy 1, failed 
back surgery syndrome 2,3,4,5, complex regional pain syndrome 6,7, phantom limb pain 8, ischemic limb pain 
9, refractory unilateral limb pain syndrome 3, postherpetic neuralgia and acute herpes zoster pain 10. 
A systematic review and meta-analysis of SCS in refractory neuropathic back and leg pain 11 documented 
that SCS reduces pain, improves quality of life, reduces analgesic use, allows some patients to return to 
work, and may also result in significant cost savings over time with minimal significant adverse events.  
Historically, SCS has delivered a tonic stimulation pattern where impulses are delivered at a consistent 
amplitude, frequency, and pulse width, typically producing paresthesia (tingling sensation) over the patient’s 
area of pain. A variety of amplitudes, frequencies, and pulse widths can be programmed along with an 
option to turn the stimulation on and off throughout the day (known as Cycle Mode). However, recent 
technical developments provide expanded stimulation options. St. Jude Medical developed the Prodigy 
(MRI)™ and Proclaim Elite™ systems, both of which are capable of producing either tonic stimulation (see 
Figure 1) or BurstDRTM stimulation (Figure 2). 
BurstDR stimulation features a series of impulses in rapid succession, known as a burst train, followed by 
a short silent phase. Programmable parameters include the amplitude of the burst train, the time from onset 
of one burst train to the onset of the next burst train (burst rate), and the rate of pulses within each train 
(intra-burst rate) (See Figure 2).  BurstDR is thought to improve SCS effectiveness by mimicking the natural 
burst firing patterns found in the brain 12. Amplitudes programmed for BurstDR are typically lower than those 
traditionally used for tonic stimulation, often resulting in pain suppression without paresthesia. 
 
Previous studies using BurstDR have examined the safety and efficacy of the stimulation mode for patients 
who were already using tonic stimulation 13, 14, 15, 16. These studies reported favorable outcomes for the new 
stimulation mode, with many patients achieving greater pain control and experiencing less paresthesia with 
BurstDR compared to tonic stimulation. Currently, the body of evidence for BurstDR is limited to subjects 
with prior experience using tonic stimulation. Patients who trial the SCS system with tonic stimulation may 
be conditioned to associate paresthesia with pain relief. When the patient then switches to BurstDR 
stimulation, the lack of paresthesia may violate that previous association and reduce the potential benefit 
of treatment. The SUNBURST trial 16 provides some evidence that this may be the case. In the trial, BurstDR 
stimulation was shown to provide more pain relief than tonic stimulation, but 22% of the patients who failed 
to achieve at least 30% pain reduction with BurstDR did achieve clinically relevant pain relief with tonic 
stimulation. It is possible that these patients would have responded to BurstDR had they not previously 
been conditioned to tonic stimulation. Data regarding patients who use BurstDR stimulation from the 
beginning of their exposure to SCS is necessary to fully evaluate any qualitative or quantitative differences 
in therapy outcomes for the two waveforms. 
 
The SUNBURST trial in the US and PRODIGY I PMCF in Europe demonstrated clinically meaningful pain 
reduction with BurstDR at one year; however, no studies to date have reported outcomes beyond 12 
months. Longer-term follow-up is needed to demonstrate sustainable pain relief over time.   
 
For devices that deliver both tonic and BurstDR waveforms, individual patient characteristics (e.g. pain 
history, mental/physical health, and sensory experience) may affect the way a patient achieves maximum 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 7 of 44 
 
benefit from the therapy. After an initial crossover period, SUNBURST allowed patients to select the 
program mode (tonic or BurstDR) according to individual preference during the follow-up period. 
Approximately 60% of subjects used BurstDR most frequently at one year, while the other 40% used some 
combination of tonic and BurstDR programs. The relationships between program usage patterns, patient 
characteristics, and long-term outcomes have yet to be examined for these multi-waveform SCS devices. 
Exploring these relationships will likely provide valuable insight into patient needs and enhance clinical care 
decisions.  
 
Given the evidence gaps described above for BurstDR and multi-waveform devices, the goals of the current 
study are: to assess pain relief for BurstDR stimulation when presented as the initial SCS experience, 
assess long-term outcomes for BurstDR, and to explore the relationship between program usage patterns, 
patient characteristics, and therapy outcomes. 
 
 
Figure 1: Tonic pattern 
 
 
 
Figure 2: BurstDR pattern 
 
 
  
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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3 
Device(s) Under Investigation 
 
Identification and Description of the Devices under investigation 
Table 1: Identification of Devices under Investigation 
 
Device Type 
Device name 
Model/
Type 
Description 
Investigational 
or Market 
Released 
Trial System 
SJM Invisible 
Trial System 
3599 
& 
3032 
The SJM Invisible Trial™ System is an external 
pulse generator (model 3599) with disposable 
header (model 3032) that connects to, and is 
compatible with, commercially available SJM trial 
leads and extensions. It provides electrical 
stimulation 
to 
nerve 
structures 
either 
intraoperatively or post-operatively during a trial 
system evaluation period. The External Pulse 
Generator (EPG) can support up to 16 active 
electrodes. 
Stimulation settings are wirelessly programmed 
securely over Bluetooth using the Clinician 
Programmer and stored on the EPG. 
Batteries support a 14-day trial system evaluation 
period and the EPG also supplies diagnostics that 
can provide the user additional data regarding the 
neurostimulation trial. 
A complete description and illustration of use are 
provided 
in 
the 
External 
Pulse 
Generator 
Clinician’s Manual. 
Market 
Released 
Trial System 
Multiprogram 
Trial 
Stimulator® 
(MTS) - can 
only be used 
for on- the- 
table trials. 
3510 
The Multiprogram Trial Stimulator System (MTS) is 
a programmable device designed to deliver low-
intensity electrical impulses to nerve structures in 
the dorsal aspect of the spinal cord.  The system 
consists of an external stimulator, one or two trial 
cables, and percutaneous leads. The stimulator is 
a small, battery-powered, external device that 
delivers electrical impulses through the trial cable 
to the implanted lead(s). It contains electronic 
circuitry that allows the stimulator to be easily 
programmed with different stimulation settings for 
versatile pain control therapy.   
Market 
Released 
IPG 
Proclaim Elite 
5 IPG & 
Proclaim Elite 
7 IPG  
3660 
& 
3662 
This Implantable Pulse Generator (IPG) is an 
electronic device designed to be connected to one 
or more extensions or leads with up to 16 
electrodes in total. It is powered by a hermetically 
sealed battery within a titanium case and uses 
microelectric circuitry to generate constant-current 
electrical stimulation. The IPG can be programmed 
with multiple stimulation options. Each program 
can provide stimulation to a single anatomical area 
or to multiple areas, using either a tonic or BurstDR 
waveform. The IPG communicates wirelessly with 
Market 
Released 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 9 of 44 
 
the system programmer and controller, and IPG’s 
are available in small (3660) and large (3662) sizes 
to accommodate different power needs. These 
models can receive software upgrades after 
implantation to provide patients with additional 
features as approved by the respective regulatory 
agencies. 
A complete description and illustration of use are 
provided in the Clinician’s manual of the Proclaim 
Elite IPG. 
IPG 
Prodigy IPG 
3799 
The Prodigy IPG is a rechargeable, electronic 
device designed to be connected to one or more 
leads. It is powered by a hermetically sealed 
battery 
within 
a 
titanium 
case 
and 
uses 
microelectronic circuitry to generate constant 
current electrical stimulation. The IPG can deliver 
stimulation with a range of waveforms (called 
MultiStimTM) depending on the individual patient’s 
need. Prodigy is enabled to deliver both tonic and 
BurstDR stimulation. 
 
A complete description and illustration of use are 
provided in the Clinician’s manual of the Prodigy 
IPG  
Market 
Released 
IPG 
Prodigy MRI 
IPG 
3772 
The Prodigy MRI IPG is a rechargeable, electronic 
device designed to be connected to one or more 
leads. It is powered by a hermetically sealed 
battery within a titanium case and uses 
microelectronic circuitry to generate constant 
current electrical stimulation. The IPG can deliver 
stimulation with a range of waveforms (called 
MultiStim) depending on the individual patient’s 
need. Prodigy MRI is enabled to deliver both tonic 
and BurstDR stimulation and is conditionally 
approved for Magnetic Resonance Imaging (MRI) 
scans only when they meet the requirements. 
 
A complete description and illustration of use are 
provided in the Clinician’s manual of the Prodigy 
MRI. 
Market 
Released 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 10 of 44 
 
Clinician 
Programmer 
SJM Clinician 
Programmer 
for Invisible 
Trial System 
and Proclaim 
Elite 5 and 7 
3872 
The Clinician Programmer is a tablet-based 
programmer (iPad mini) that controls the creation 
and adjustment of all programming information for 
the SJM Invisible Trial EPG and Proclaim Elite IPG. 
The software is an iPad mini app with model 
number 3870 (for EPG) and 3874 (for IPG) or 
subsequent updates that runs on a standard 
commercial Apple iPad mini. The Clinician 
Programmer communicates with the EPG and IPG 
using Bluetooth Low Energy (BLE) technology. As 
with past SJM programmer models, this Clinician 
Programmer enables users to create and modify 
stimulation programs. 
A complete description and illustration of use are 
provided in the Clinician Programmer Clinician’s 
Manual. 
Market 
Released 
Clinician 
Programmer 
Rapid 
Programmer  
System for 
Prodigy 
(MRI) 
 
3835 
& 
3834 
The Rapid Programmer™ is intended to help 
clinicians determine the best performance of a 
neuromodulation system by leading the physician 
through a series of parameter combinations for the 
neuromodulation 
system 
and 
recording 
the 
stimulation effects. The device is intended to be 
used for programming the Prodigy (MRI) device 
while it is disconnected from an external power 
source. The clinician programming external device 
allows activation of BurstDR programs in addition 
to traditionally available tonic programs.  
 
A complete description and illustration of use are 
provided in the Clinician’s manual of the Rapid 
Programmer system. 
Market 
Released 
Patient 
Controller 
Patient 
Controller 
(iPod touch) 
for the 
Invisible Trial 
System 
3873 
The Patient Controller is a simplified controller that 
enables adjustment of pre-specified programming 
information for the SJM Invisible Trial System. The 
software is an iPod touch app with model number 
3871 that runs on a standard commercial Apple 
iPod touch using BLE technology. As with past 
SJM controller models, this Patient Controller 
enables users to adjust stimulation programs. 
A complete description and illustration of use are 
provided in the Patient Controller User’s Guide. 
Market 
Released 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 11 of 44 
 
Patient 
Controller 
iPod touch 
Mobile Digital 
Device for 
Proclaim Elite 
5 & 7 
3883 
The Patient Controller is a simplified controller that 
enables adjustment of pre-specified programming 
information for the Proclaim Elite IPG. The software 
is an iPod touch app with model number 3875 that 
runs on a standard commercial Apple iPod touch 
using BLE technology. As with past SJM controller 
models, this Patient Controller enables users to 
adjust stimulation programs. 
A complete description and illustration of use are 
provided in the Patient Controller User’s Guide 
Market 
Released 
Patient 
Controller 
Prodigy 
(MRI) patient 
programmer 
for Prodigy 
and Prodigy 
MRI 
 
3855 
& 
3856 
The Prodigy (MRI) patient programmer controls the 
creation and adjustment of all programming 
information for the Prodigy IPG (3855) and Prodigy 
MRI (3856). The device communicates by using 
radiofrequency (RF) signals from the programming 
wand to the implanted IPG. The device enables 
clinicians to create and modify programs for the 
IPG. It also provides patients with Patient-
Controlled Stimulation technology, which enables 
them to choose between several prescribed 
programs stored in the device’s memory. The 
Prodigy (MRI) Patient Controller External Device 
introduces the ability for a patient to select (an) 
existing BurstDR program(s) in addition to 
traditionally available tonic program(s).  
 
A complete description and illustration of use are 
provided in the Prodigy (MRI) patient programmer 
user’s guide. 
Market 
Released 
 
Prodigy 
(MRI) 
Charging 
System 
 
3730 
The Prodigy (MRI) Charging System provides the 
capability to recharge the IPG battery while 
stimulation is either on or off. The system consists 
of a charger, antenna, power adapter, and power 
cable. The charger transmits RF energy through 
the antenna to the IPG battery to recharge it.  
 
A complete description and illustration of use are 
provided in the Prodigy (MRI) Charging system 
user’s guide. 
Market 
Released 
 
Leads/Extens
ions 
/Accessories  
 
Any 
compatible 
and 
commercially 
available 
lead/extension and accessory may be used in the 
study. 
 Market 
Released 
 
3.1.1 
Device Description and Intended Purpose 
In this study, the commercially available St. Jude Medical Invisible Trial System will be used according to 
the Instructions for Use (or any other SJM EPG system with BurstDR form functionality when available and 
approved for use). For on-the-table trials (when the trial system evaluation and permanent implant are done 
during the same procedure) only, the MTS can be used according to the Instructions for Use. 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 12 of 44 
 
In this study, any commercially available Prodigy (MRI) neurostimulation system or Proclaim Elite system 
will be used according to the Instructions for Use (or any other SJM spinal cord stimulation system with 
both tonic and BurstDR form functionality when available and approved for use). 
 
Both Prodigy (MRI) and Proclaim Elite neuromodulation systems are indicated as an aid in the management 
of chronic, intractable pain of the trunk and/or limbs. 
 
3.1.2 
Device Handling and Storage 
The devices used during this study are commercially available and will be handled and stored according 
to the applicable product manuals and standard site practices. 
4 
Clinical Investigation Design 
 
Clinical Investigation Design  
 
The study is designed as a post-market, international, multicenter, interventional, prospective, single-arm 
study. The purpose of this clinical study is to examine pain relief and other outcomes for subjects with 
chronic, intractable pain of the trunk and/or limbs who use BurstDR stimulation during the trial evaluation 
period and at 6, 12, 18 and 24 months after permanent system implant. Furthermore, the study seeks to 
explore sustainable pain relief, psychological outcomes, and stimulation usage patterns with a device 
capable of delivering multiple stimulation modes (BurstDR and tonic) through 24 months post-permanent 
implant. Finally, this study will collect MRI safety information, when available, for enrolled patients. 
 
The investigation will be conducted in approximately 30 centers in EMEA, US, Canada and ANZ. Estimated 
enrollment duration is approximately 18 months with 24 months follow-up. Approximately 267 subjects will 
be enrolled in the study. A maximum of 53 subjects can be included per center. The study may continue up 
to 4 years, dependent on the rate of enrollment (approximately 18 months enrollment + 24 months follow-
up + time to close the investigation and provide final report). 
 
Objectives 
4.2.1 
Primary Objectives 
The primary objective is to evaluate pain relief in subjects with a multiple-waveform enabled 
neurostimulator. 
 
4.2.2 
Secondary Objectives 
The secondary objectives are to evaluate the psychosocial and functional responses in subjects with a 
multiple-waveform enabled neurostimulator. 
 
 
Endpoints 
4.3.1 
Primary Endpoint 
The primary endpoint is change from baseline to 6 months post-permanent implant in pain assessed by 
using the Numeric Rating Scale (NRS). 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 13 of 44 
 
4.3.2 
Secondary Endpoint 
o 
Change from baseline to 6 months post-permanent implant for quality of life measured using the 
EuroQuol -5 Dimensions (EQ5D) questionnaire. 
o 
Change from baseline to 6 months post-permanent implant for pain catastrophizing measured using 
the Pain Catastrophizing Scale (PCS). 
o 
Change from baseline to 6 months post-permanent implant for anxiety measured using the State-Trait 
Anxiety Inventory (STAI). 
o 
Change from baseline to 6 months post-permanent implant for depression measured using the Patient 
Health Questionnaire-9 (PHQ9). 
o 
Change from baseline to 6 months post-permanent implant for fear avoidance measured using the 
Tampa Scale for Kinesiophobia (TSK). 
o 
Change from baseline to 6 months post-permanent implant for sleep measured using the Medical 
Outcome Study (MOS) Sleep Scale. 
o 
Change from baseline to 6 months post-permanent implant for physical function measured using the 
Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale. 
4.3.3 
Demographic/Baseline Characteristic and Descriptive Endpoint(s) 
 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for quality of life measured 
using the EQ5D questionnaire. 
o 
Change from baseline to 3, 12, 18, and 24 months post-permanent implant for pain catastrophizing 
measured using the PCS. 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for anxiety measured using 
the STAI. 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for depression measured using 
the PHQ9.  
o 
Change from baseline to 3, 12, 18 and 24 months post-permanent implant for fear avoidance measured 
using the TSK. 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for sleep measured using the 
MOS Sleep Scale.  
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for physical function measured 
using the PROMIS Physical Function Scale. 
o 
Change from baseline to End of Trial system evaluation 3, 12, 18, and 24 months post-permanent 
implant in pain assessed by using the NRS. 
o 
Demographics and baseline characteristics. 
o 
Patient waveform preference (if applicable). 
o 
Patient satisfaction at End of Trial system evaluation 3, 6, 12, 18, and 24 months post-permanent 
implant. 
o 
Global improvement of the patient by using the Patient Global Impression of Change (PGIC) at End of 
Trial System Evaluation 3, 6, 12, 18, and 24 months. 
o 
Medication usage measured in decrease in chronic pain related medication intake since baseline at 3, 
6, 12, 18, and 24 months post-permanent implant. 
o 
Battery consumption and/or recharging activities. 
o 
Stimulation Assessment measured by using the Stimulation Assessment Form at 3, 6, 12, 18, and 24 
months post-permanent implant as well as any unscheduled visit where reprogramming occurs. 
o 
Program information including amplitude, pulse width, frequency and electrode configuration. 
o 
System information including device type, model number, serial number and number of leads. 
o 
Proportion of device, or procedure-related Serious Adverse Events (SAE’) s and non-serious adverse 
events in subjects who receive permanent implant of the SCS system. 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 14 of 44 
 
 
Study Population 
The patient population enrolled in this study will be comprised of male and female patients. Patients must 
meet the specific eligibility criteria to participate in the study.  
 
A patient, who meets all inclusion criteria, and none of the exclusion criteria, is eligible to participate in this 
study.  
 
4.4.1 
Inclusion Criteria 
1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain 
associated with the following:  failed back surgery syndrome and intractable low back and leg pain. 
2. Subject has a score of 6 or higher on the NRS for average pain specific to the area(s) of chronic 
pain being treated over the past 24 hours at the baseline visit. 
3. Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator 
system according to the system Instructions for Use. 
4. Subject is 18 years of age or older at the time of enrollment. 
5. Subject is willing to cooperate with the study requirements including compliance with the regimen 
and completion of all study visits. 
6. Subject has signed and received a copy of the Ethics Committee/Institutional Review Board 
(EC/IRB) approved informed consent.  
4.4.2 
Exclusion Criteria 
1. Subject currently has a spinal cord stimulation system implanted. 
2. Subject has previously failed SCS therapy (either trial system evaluation or permanent implant). 
3. Subject has a primary diagnosis for SCS implantation of Peripheral Vascular Disease (PVD), 
Angina Pectoris, or Chronic Migraine. 
4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field 
Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump. 
5. Subject is currently participating in another clinical investigation with an active treatment arm. 
6. Subject is unable to read and/or write. 
5 
Procedures 
 
The clinical study will be conducted in accordance with the CIP.  All parties participating in the conduct of 
the clinical study will be qualified by education, training, or experience to perform their tasks and this training 
will be documented appropriately. 
 
The clinical study will not commence until Abbott receives written approval from the IRB/EC and relevant 
regulatory authorities and all required documents have been collected from the site(s). 
 
The following sections provide a detailed description of procedures required by this CIP. 
 
Informed Consent Process 
The Principal Investigator (PI) or his/her authorized designee will conduct the Informed Consent Process, 
as required by applicable regulations and the center’s IRB/EC. This process will include a verbal discussion 
with the subject on all aspects of the clinical investigation that are relevant to the subject’s decision to 
participate, such as details of clinical investigation procedures, anticipated benefits, and potential risks of 
clinical investigation participation. During the discussion, the Principal Investigator or his/her authorized 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 15 of 44 
 
designee will avoid any improper influence on the subject and will respect subject’s legal rights. The subject 
shall be provided with the informed consent form written in a language that is understandable to the subject 
and has been approved by the center’s IRB/EC. The subject shall have adequate time to review, ask 
questions and consider participation. 
 
If the subject agrees to participate, the Informed Consent form must be signed and dated by the subject 
and by the person obtaining the consent. The signed original will be filed in the subject’s hospital or research 
charts, and a copy will be provided to the subject. 
 
The Principal Investigator or his/her authorized designee will document the informed consent process in 
the subject’s hospital and/or research charts. The date of signature will be entered on an applicable Case 
Report Form (CRF). 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment should be reported 
to Sponsor within 5 working days and to the reviewing center’s IRB/EC according to the IRB’s/ EC’s 
reporting requirements. 
If, during the clinical investigation, new information becomes available that can significantly affect a 
subject's future health and medical care, the Principal Investigator or his/her authorized designee will 
provide this information to the subject. If relevant, the subject will be asked to confirm their continuing 
informed consent in writing. 
 
Point of Enrollment 
Patients are considered enrolled in the study from the moment the patient has provided written Patient 
Informed Consent (Refer to section 5.1 for the Informed Consent Process).  
 
Scheduled Procedures 
The Principal Investigator is responsible for ensuring all clinical investigation data is collected as required 
per CIP scheduled procedures. 
5.3.1 
Baseline 
(in clinic, visit must be completed minimum 3 days and max 45 days before the trial system evaluation) 
 
The following activities must occur before any study procedure/visit. 
 
• 
The Principal Investigator or delegated study personnel is responsible for screening all potential 
patients to determine patient eligibility for the study. 
• 
If a patient meets all inclusion criteria and does not meet any of the exclusion criteria, he/she is 
eligible for the study. 
• 
The patient is enrolled in the study when the patient signed the EC/IRB approved Informed Consent 
form. 
 
Record enrollment information (name of the study, date of consent and Inclusion/Exclusion information) in 
the hospital records and complete the Baseline CRF electronically preferably within 5 days after enrollment. 
Notification of enrollment to the Sponsor will take place only when the Sponsor receives the Baseline CRF. 
  
NOTE: As soon as the patient signs the Patient Informed Consent form, all Adverse Device Effects and all 
Serious Adverse Events need to be reported according to the guidelines mentioned in this CIP (refer to 
section 8.2). 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 16 of 44 
 
In case the subject was consented to participate in the study, but does not meet inclusion/exclusion criteria, 
and was not implanted, the subject should be withdrawn and a withdrawal form must be completed. The 
patient will resume his/her regular standard of care with his/her physician. 
 
In case the subject was consented to participate in the study and was implanted but does not meet 
inclusion/exclusion criteria, then this is considered a protocol violation. A protocol deviation form needs to 
be completed and the Sponsor must be informed. The EC/IRB and Competent Authority (CA), if applicable, 
should be notified appropriately about any deviations with regards to the violation of inclusion/exclusion 
criteria. 
 
The following information will be collected at the baseline visit: 
• 
Demographics, Pain History, Pain Primary/Secondary Diagnosis, occupational/lifestyle information 
• 
NRS 
• 
Other Patient Reported Outcome Measures (EQ5D questionnaire, PCS, STAI, PHQ9, TSK, MOS 
Sleep Scale, PROMIS Physical Function scale, Pain Location).  
• 
Chronic Pain related medication usage 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 
5.3.2 
Trial System Implant 
(In clinic, prior to permanent implantation, within 3-45 days from Baseline visit) 
Subjects must undergo a successful trial system evaluation of the SCS system prior to permanent 
implantation of the SCS system. It is a requirement that the subjects will be trialed with BurstDR and only 
a BurstDR program will be provided to, and used by, the subject. In case of an on-the-table trial evaluation 
(aka all-in-one procedure), the pain mapping can be done with tonic. The trial system evaluation procedure 
will be conducted according to the national standards and guidelines. The SCS Trial System Evaluation 
visit will include recording the following: 
 
• 
Trial System implant and system information  
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 
5.3.3 
End of Trial System Evaluation 
(In clinic, prior to permanent implantation, timing in accordance with physician standard operation 
procedures) 
If the trial system evaluation is unsuccessful, per standard of care, the subject is considered as a trial 
system failure and must be withdrawn from the study (withdrawal date is the date when the trial system 
evaluation ended). The End of Trial System Evaluation visit will include recording the following: 
 
• 
Trial system evaluation conclusion information, patient reported pain relief and patient satisfaction 
• 
Patient Reported Outcome Measures (NRS, PGIC) 
• 
Programming information and program usage including programming parameters record 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 17 of 44 
 
 
5.3.4 
Permanent System Implant 
(In clinic, timing in accordance with physician standard operation procedures) 
Implantation of the SCS system will be performed according to standard operating procedures and will 
occur after a successful trial system evaluation period. Subjects will receive a patient programmer and will 
be instructed on how to use the system to relieve their pain. Subjects will be able to adjust the stimulation 
in order to generate the best results. Following system implantation, the stimulator will be activated and 
programmed by trained personnel and/or an Abbott representative either during post-operative recovery or 
at an office visit in accordance with the physician’s and hospital’s standard operating procedures. As of 
permanent implant, the subject can be stimulated with both tonic and/or BurstDR waveforms. The SCS 
system implantation will include recording of the following: 
 
• 
Permanent system implant and system information 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
MRI information (if applicable) 
• 
Death (if applicable) 
5.3.5 
3-Month Follow-up Visit 
± (In clinic, 3 months post-permanent implant +/-30 days) 
Enrolled and permanent system implanted subjects will be evaluated at 3 months post-permanent 
implantation of the SCS system. In case the subject requires reprogramming, it should be performed before 
the print-out of the current programming parameters record and prior to any study visit assessments.  
During the visit, the following evaluations and procedures will be performed. 
• 
Occupational/lifestyle information 
• 
NRS, PGIC, patient satisfaction, patient reported pain relief, battery usage 
• 
Other Patient Reported Outcome Measures (PCS, TSK, Stimulation Assessment, Pain Location) 
• 
Programming information and program usage including programming parameters record 
• 
Chronic Pain related medication usage 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
MRI information (if applicable) 
• 
Death (if applicable) 
5.3.6 
6-Month Follow-up Visit 
This visit should be conducted in-clinic 6 months (±30 days) post-permanent implant. 
Subjects with a permanent implant will be evaluated 6 months after initial permanent system implant. In 
case the subject requires reprogramming, it should be performed before the printout of the current 
programming parameters record and prior to any study visit assessments.  During the visit, the following 
evaluations and procedures will be performed. 
• 
Occupational/life style information 
• 
NRS, PGIC, patient satisfaction, patient reported pain relief, battery usage 
• 
Other Patient Reported Outcome Measures (EQ5D questionnaire, PCS, STAI, PHQ9, TSK, MOS sleep 
scale, PROMIS physical function scale, Pain Location, Stimulation Assessment) 
• 
Programming information and program usage including programming parameters record 
• 
Chronic Pain related medication usage 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 18 of 44 
 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
MRI information (if applicable) 
• 
Death (if applicable) 
5.3.7 
12-Month Follow-up Visit 
This visit should be conducted in-clinic 12 months (±60 days) post-permanent implant  
Subjects with a permanent implant will be evaluated 12 months after initial permanent system implant. In 
case the subject requires reprogramming, it should be performed before the printout of the current 
programming parameters record and prior to any study visit assessments.  During the visit, the following 
evaluations and procedures will be performed. 
• 
Occupational/life style information 
• 
NRS, PGIC, patient satisfaction, patient reported pain relief, battery usage 
• 
Other Patient Reported Outcome Measures (EQ5D questionnaire, PCS, STAI, PHQ9, TSK, MOS sleep 
scale, PROMIS physical function scale, Pain Location, Stimulation Assessment) 
• 
Programming information and program usage including programming parameters record 
• 
Chronic Pain related medication usage 
• 
Adverse events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
MRI information (if applicable) 
• 
Death (if applicable) 
5.3.8 
18-Month Follow-up Visit  
This visit should be conducted in-clinic 18 months (±60) days post-permanent implant  
Subjects with a permanent implant will be evaluated 18 months after initial permanent system implant. In 
case the subject requires reprogramming, it should be performed before the printout of the current 
programming parameters record and prior to any study visit assessments.  During the visit, the following 
evaluations and procedures will be performed. 
• 
Occupational/life style information 
• 
NRS, PGIC, patient satisfaction, patient reported pain relief 
• 
Other Patient Reported Outcome Measures (EQ5D questionnaire, PCS, STAI, PHQ9, TSK, MOS sleep 
scale, PROMIS physical function scale, Pain Location, Stimulation Assessment) 
• 
Programming information and program usage including programming parameters record 
• 
Chronic Pain related medication usage 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
MRI information (if applicable) 
• 
Death (if applicable) 
5.3.9 
24-Month Follow-up Visit 
This visit should be conducted in-clinic 24 months +/- 60 days post-permanent implant  
Subjects with a permanent implant will be evaluated 24 months after initial permanent system implant. In 
case the subject requires reprogramming, it should be performed before the printout of the current 
programming parameters record and prior to any study visit assessments.  During the visit, the following 
evaluations and procedures will be performed. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 19 of 44 
 
• 
Occupational/life style information 
• 
NRS, PGIC, patient satisfaction, patient reported pain relief 
• 
Other Patient Reported Outcome Measures (EQ5D questionnaire, PCS, STAI, PHQ9, TSK, MOS sleep 
scale, PROMIS physical function scale, Pain Location, Stimulation Assessment) 
• 
Programming information and program usage including programming parameters record 
• 
Chronic Pain related medication usage 
• 
Subject study completion 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
MRI information (if applicable) 
• 
Death (if applicable) 
5.3.10 MRI information (if applicable) 
An MRI procedure is not indicated as part of this clinical investigation. If an MRI is performed as part of 
standard practice after permanent device implant, details related to the MRI parameters, device 
functionality, and adverse events will be collected to evaluate the safety of the SCS device. Note: Guidelines 
for performing an MRI are contained in the MRI Procedure Information Clinician’s Manual for compatible 
devices.  
5.3.11 Death (if applicable), Revisions, Replacements or Explants (Additional Surgery) 
The subject and the implanting physician will collectively make the decision about any possible revision, 
replacement or explant 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.  The following information will be collected only for revisions, 
replacements or explants that occur after the initial permanent procedure: 
• 
Permanent implant and system information (including accessories)  
• 
Reason for revision, replacement or explant 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 
 
If the device is explanted for any reason, and re-implantation is not an option, the subject will be withdrawn 
from the study.  Subjects who undergo a revision or replacement procedure will resume their previous 
follow-up schedule. 
 
Patient Reported Outcome (PRO) Measures 
The Study Coordinator or designee will give the subject questionnaires to complete on his or her own or 
apply an interview technique. 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 question unless otherwise noted. 
The questionnaires to be completed by the subject will have to be administered in this order; 
1. EuroQol 5- Dimensions Questionnaire (EQ5D) 
2. Pain Catastrophizing Scale (PCS) 
3. State-Trait Anxiety Inventory for Adults (STAI) 
4. Patient Health Questionnaire-9 (PHQ9) 
5. Tampa Scale for Kinesiophobia (TSK)  
6. Medical Outcome Study (MOS) Sleep Scale 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 20 of 44 
 
7. Patient-Reported Outcome Measure Information System (PROMIS) Physical Function (if 
available in the country) 
 
The following PRO measures will be collected according to the study requirements. 
5.4.1 
EuroQol 5- Dimensions Questionnaire (EQ5D) (EuroQol Group, 2009) 
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide 
range of health conditions and treatments. It provides a simple descriptive profile and a single index 
value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: 
mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 
levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is 
also included in the measure as a patient-reported estimate of overall health status. 
5.4.2 
Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, & Pivik, 1995) 
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts 
and feelings while a patient is experiencing pain).  Subjects answer questions about how they feel 
and what they think about when they are in pain (i.e., not at the current moment).  The scale includes 
13 statements concerning pain experiences that are rated on a scale between 0 ‘not at all’ and 4 
‘always’.  The scale is self-administered and takes 5 minutes to complete.  A higher score indicates 
a higher level of catastrophizing.  
5.4.3 
State-Trait Anxiety Inventory for Adults (Spielberger, 1968) 
The State-Trait Anxiety inventory is a self-administered screening for anxiety.  Subjects respond to 
40 items rated on a scale from 0 to 4.  It clearly differentiates between the temporary condition of 
“state anxiety” and the more general and long-standing quality of “trait anxiety” by providing a score 
for each. Higher scores suggest greater levels of anxiety. 
5.4.4 
Patient Health Questionnaire-9 (PHQ-9) (Spitzer, Williams & Kroenke et. al) 
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and 
measuring the severity of depression.  The questionnaire consists of 9 questions that rate the 
frequency of the symptoms of depression. A follow up non-scored question screens and assigns 
weight to the degree to which depressive problems have affected the patient’s level of function. The 
responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a 
higher likelihood of major depression. 
5.4.5 
Tampa Scale for Kinesiophobia (TSK) (Woby et al, 2005) 
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the 
original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury.  
The scale is based on the model of fear avoidance, fear of work related activities, fear of movement 
and fear of re-injury (Vlaeyan et al., 1995).  The TSK has also been linked to elements of catastrophic 
thinking (Burwinkle et al., 2005).  The scale can be useful in measuring unhelpful thoughts and beliefs 
about pain in people with chronic pain.   
5.4.6 
Medical Outcome Study (MOS) Sleep Scale (Hays & Stewart, 1992) 
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions 
of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory 
impairments.  It includes 12 questions with the first question assessing how long it takes the subject 
to fall asleep. The second question asks how many hours each night the subject slept.  The remaining 
10 questions have a range of 6 responses from 1=”all of the time” to 6=”none of the time”.  The scale 
is self-administered and validated. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 21 of 44 
 
5.4.7 
Patient-Reported Outcome Measure Information System (PROMIS) Physical Function 
– Short Form Version 1.2 
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical 
capability rather than actual performance of physical activities. The scale measures universal 
physical function rather than disease-specific impairment and assesses current function rather than 
function over a specified time period.  Each question has five potential response options ranging in 
value from one to five to give a total score ranging from 8 to 40.  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 physical function. This questionnaire is not available in all languages (e.g. Finnish); as such, 
it is only required at sites where a translation is available.  
5.4.8 
Pain Numerical Rating Score (NRS)  
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. 
5.4.9 
Pain Location 
Pain Location is assessed using a map of the body that is labelled with different numbered quadrants.  
The subject is asked via interview to indicate the area he/she is feeling pain. 
5.4.10 Stimulation Assessment 
The Stimulation Assessment Form includes questions to identify the sensations experienced when 
stimulation is used. Subjects identify the intensity and areas of sensations, if experienced. Intensity 
is rated on a scale of 0 (no feeling) to 10 (very intense). A map of the body is labeled with different 
numbered quadrants to identify the areas of sensations. The subject will be requested via interview 
technique to indicate the area he/she is feeling sensations. 
5.4.11 Patient Global Impression of Change (PGIC) (Hurst & Bolton, 2004) 
The PGIC is a categorical rating scale used to evaluate the subject’s impression of change in his/her 
condition since the beginning of the study treatment.  The subject will be requested to rate their 
overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her 
condition on a seven-point categorical scale via an interview technique.  The categories are as 
follows:  1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-
better, and 7-a great deal better.  Although this tool does not specify the area of change (e.g., pain, 
function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of 
the subject.  PGIC values of 6 or 7 are reported to correlate best with actual change (Amirfeyz et al, 
2009). 
 
Unscheduled Visits 
An Unscheduled visit is defined as any visit where an active study subject returns to the participating study 
site for medical care outside of a specified study visit.  Examples of unscheduled visits may include subjects 
returning to the office for a reportable adverse event, medication adjustment, wound check and/or device 
programming change after the permanent system implant. During the visit, the following evaluations and 
procedures will be performed: 
• 
Reason for unscheduled visit 
• 
Programming information and program usage including programming parameters record (after 
reprogramming if it occurs) 
• 
Stimulation assessment (after reprogramming if it occurs) 
• 
Adverse Events (if applicable) 
• 
Deviations (if applicable) 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 22 of 44 
 
• 
Withdrawal (if applicable) 
 
Following an Unscheduled visit, the subject should be seen for the next scheduled study visit within window. 
 
Study Flow Chart 
 
Figure 3: Study Flow Chart 
 
 
 
 
 
Subjects May Choose Any Combination of Tonic and BurstDR 
Programming at Scheduled or Unscheduled Visits 
Baseline 
Trial System Evaluation 
Period using BurstDR 
End of Trial System 
Evaluation 
3 Month Follow-up 
6 Month Follow-up 
12 Month Follow-up 
18 Month Follow-up 
24 Month Follow-up 
Trial System Failure/Declined 
permanent system implant 
Withdrawal 
Subject study completion 
Permanent System Implant and Programming 
(Burst and/or tonic per subject/clinician discretion) 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 23 of 44 
 
Table 2: List of all clinical investigation specific tests and procedures 
 
 
Visit 
 
 
 
 
 
 
 
 
 
 
 
Study Activity 
Baseline (must be completed minimum 3 
days before the trial procedure) 
Trial System Implant (within 3-45 days from 
Baseline) 
End of Trial System Evaluation 
Permanent System implant procedure   
3 Month (3 months+/- 30 days post -
permanent implant) 
6 Month (6 months +/- 30 days post -
permanent implant) 
12 Month (12 months +/- 60 days post -
permanent implant) 
18 Month (18 months +/-60 days post -
permanent implant) 
24 Month (24 months +/-60 days post -
permanent implant) 
 
Additional surgery (System Revision, 
Replacement /Explant) 
Unscheduled Visit 
Informed Consent 
Process 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
Demographics, Pain 
History & Primary 
diagnosis 
 
X 
 
 
 
 
 
 
 
 
 
 
Occupational/lifestyle 
information 
X 
 
 
 
X 
X 
X 
X 
X 
 
 
NRS 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
PGIC, patient 
satisfaction, patient 
reported pain relief 
and battery usage  
 
 
 
 
X 
X 
X 
X 
X 
 
 
EQ5D questionnaire 
X 
 
 
 
 
X 
X 
X 
X 
 
 
PCS  
X 
 
 
 
X 
X 
X 
X 
X 
 
 
STAI 
X 
 
 
 
 
X 
X 
X 
X 
 
 
PHQ9  
X 
 
 
 
 
X 
X 
X 
X 
 
 
TSK  
X 
 
 
 
X 
X 
X 
X 
X 
 
 
MOS Sleep Scale 
X 
 
 
 
 
X 
X 
X 
X 
 
 
PROMIS physical 
function scale 
X* 
 
 
 
 
 
X* 
X* 
X* 
X* 
 
 
Pain Location 
X 
 
 
 
X 
X 
X 
X 
X 
 
 
Stimulation 
Assessment 
 
 
 
 
X 
X 
X 
X 
X 
 
(X) 
Chronic Pain Related 
Medication 
X 
 
 
 
X 
X 
X 
X 
X 
 
 
 
Implant procedure 
and system data 
 
X 
 
X 
 
 
 
 
 
X 
 
Trial system 
evaluation conclusion 
 
 
X 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 24 of 44 
 
 
 
Visit 
 
 
 
 
 
 
 
 
 
 
 
Study Activity 
Baseline (must be completed minimum 3 
days before the trial procedure) 
Trial System Implant (within 3-45 days from 
Baseline) 
End of Trial System Evaluation 
Permanent System implant procedure   
3 Month (3 months+/- 30 days post -
permanent implant) 
6 Month (6 months +/- 30 days post -
permanent implant) 
12 Month (12 months +/- 60 days post -
permanent implant) 
18 Month (18 months +/-60 days post -
permanent implant) 
24 Month (24 months +/-60 days post -
permanent implant) 
 
Additional surgery (System Revision, 
Replacement /Explant) 
Unscheduled Visit 
Programming 
information and 
program usage 
including 
programming 
parameters record 
 
 
X 
 
X 
X 
X 
X 
X 
 
(X) 
Reason for 
revision/replacement/
explant 
 
 
 
 
 
 
 
 
 
 
X 
 
Reason for 
unscheduled visit 
 
 
 
 
 
 
 
 
 
 
X 
Adverse Event  
(X) 
(X) 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Deviation 
(X) 
(X) 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Withdrawal 
(X) 
(X) 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
MRI evaluation 
 
 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
 
(X) 
Death 
(X) 
(X) 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Subject study 
completion 
 
 
 
 
 
 
 
 
X 
 
 
 
X* if the translated questionnaire is available in the country 
(X) if applicable 
 
Description of Activities Performed by Sponsor Representatives 
Trained Sponsor personnel will provide technical expertise and technical guidance on the use of the SCS 
systems, including training and proctored case coverage. 
 
While Sponsor representatives may perform these activities, the Principal Investigator remains responsible 
for ensuring all clinical investigation data is collected as required per CIP. 
 
Subject Study Completion 
When the subject’s participation in the clinical study has been completed, the subject will return to the 
medical care as per physician’s recommendation. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 25 of 44 
 
 
Subject Withdrawal 
Respecting the subject’s right to withdraw, the Investigator should make all reasonable efforts to retain the 
subject in the clinical investigation until completion of the clinical investigation. Subjects must be informed 
about their right to withdraw from the clinical investigation at any time and for any reason without sanction, 
penalty or loss of benefits to which the subject is otherwise entitled. Withdrawal from the clinical 
investigation will not jeopardize their future medical care or relationship with the Investigator. Subjects will 
be requested to specify the reason for the request to withdraw. Reasons for subject’s withdrawal include, 
but are not limited to: 
 
• 
Subject refuses to continue participating in the study. 
• 
Subject does not meet the inclusion/exclusion criteria  
• 
Subject is deceased (cause must be documented). 
• 
Subject’s non-compliance. 
• 
Subject’s participation is terminated by the PI or Investigator, although the subject consented, since 
participation is no longer medically appropriate. 
• 
Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow up visits but has not 
explicitly requested to be withdrawn from the clinical study (this does not apply to missed visits). Site 
personnel should 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. 
 
A subject will be considered ‘Lost to Follow-up’ after 2 consecutive missed visit(s) and a minimum of 
two unsuccessful phone calls from investigational site personnel to the subject or contact to schedule 
the next follow-up visit. These two phone calls must be documented in the subject’s hospital records. 
If the subject is deemed lost to follow-up a letter should be sent to the subject’s last known address 
or to the subject’s general practitioner (GP) and a copy of the letter must be maintained in the 
subject’s hospital records. This letter serves as a last attempt to bring the patient back into 
compliance. If the patient does not return to the hospital for the next study visit within 2 weeks after 
the letter was sent, the subject shall be considered as withdrawn. The date of withdrawal should be 
the date of the first missed study visit.  
 
When subject withdrawal from the clinical investigation occurs, the subject should be followed up as part of 
standard care. The status of the subject’s condition should be documented at the time of withdrawal. 
6 
Statistical Considerations 
6.1.1 
Primary Endpoint  
The analysis population will include subjects who complete the NRS at both baseline and 6-month follow-
up visit.  The primary endpoint will be calculated as follows: 
 
Change in pain = pain at 6 months assessed by NRS – pain at baseline assessed by NRS 
Relative Change in pain (%) = (change in pain at 6 months/pain at baseline assessed by NRS)*100% 
 
Change and relative change (%) in pain will be summarized by mean and standard deviation, median, 
minimum, maximum and a 95% confidence interval. Results will be descriptively compared to data from 
existing tonic and BurstDR trials to evaluate efficacy. 
6.1.2 
Secondary Endpoints 
The following secondary endpoints will be used to evaluate the relationship between patient 
characteristics, program usage, and therapy outcomes. Endpoints will be summarized by mean, standard 
deviation, median, minimum, maximum, and a 95% confidence interval. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 26 of 44 
 
6.1.2.1 
Change in Quality of life 
 
The endpoint will be measured using the EQ5D questionnaire.  The analysis population will include subjects 
who complete the EQ5D questionnaire at baseline and at the 6-month follow-up visit.  The endpoint will be 
calculated as a raw difference score as well as relative change reported as a percentage change from 
baseline. 
6.1.2.2 
Change in Sleep 
 
The endpoint will be measured using the MOS Sleep Scale.  The analysis population will include subjects 
who complete the MOS Sleep Scale at baseline and at the 6-month follow-up visit.  The endpoint will be 
calculated as a raw difference score as well as relative change reported as a percentage change from 
baseline. 
6.1.2.3 
Change in Physical Function 
 
The endpoint will be measured using the PROMIS Physical Function Scale.  The analysis population will 
include subjects who complete the PROMIS Physical Function Scale at baseline and at the 6-month follow-
up visit.  The endpoint will be calculated as a raw difference score as well as relative change reported as a 
percentage change from baseline. 
6.1.2.4 
 Change in Fear Avoidance 
 
The endpoint will be measured using the TSK.  The analysis population will include subjects who complete 
TSK at baseline and at the 6-month follow-up visit.  The endpoint will be calculated as a raw difference 
score as well as relative change reported as a percentage change from baseline.  
6.1.2.5 
Change in Anxiety 
 
The endpoint will be measured using the STAI.  The analysis population will include subjects who complete 
the STAI at baseline and at the 6-month follow-up visit. The endpoint will be calculated as a raw difference 
score as well as relative change reported as a percentage change from baseline.  
6.1.2.6 
Change in Depression 
 
The endpoint will be measured using the PHQ9.  The analysis population will include subjects who complete 
the PHQ9 at baseline and at the 6-month follow-up visit. The endpoint will be calculated as a raw difference 
score as well as relative change reported as a percentage change from baseline.  
6.1.2.7 
Change in Pain Catastrophizing 
 
The endpoint will be measuring using the Pain Catastrophizing Scale. The analysis population will include 
subjects who complete the PCS at baseline and at the 6-month follow-up visit. The endpoint will be 
calculated as a raw difference score as well as relative change reported as a percentage change from 
baseline. 
6.1.3 
 Demographic/Baseline Characteristic and Descriptive Endpoints 
The following descriptive endpoints will be reported: 
 
o 
Change from baseline to 12, 18, and 24 months post-permanent implant for quality of life measured 
using the EQ5D questionnaire will be summarized by mean, standard deviation and 95% confidence 
interval. 
o 
Change of the PCS score from baseline at 3, 12, 18 and 24 months post-permanent implant will be 
summarized by mean, standard deviation, and 95% confidence interval. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 27 of 44 
 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for anxiety measured using 
the STAI will be summarized by mean, standard deviation, and 95% confidence interval. 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for depression measured using 
the PHQ9 will be summarized by mean, standard deviation, and 95% confidence interval. 
o 
Change from baseline to 3, 12, 18 and 24 months post-permanent implant for fear avoidance measured 
using the TSK will be summarized by mean, standard deviation, and 95% confidence interval. 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for sleep measured using the 
MOS Sleep Scale will be summarized by mean, standard deviation, and 95% confidence interval. 
o 
Change from baseline to 12, 18 and 24 months post-permanent implant for physical function measured 
using the PROMIS Physical Function Scale will be summarized by mean, standard deviation, and 95% 
confidence interval. 
o 
Change from baseline to End of Trial System Evaluation 3, 12, 18, and 24 months post-permanent 
implant for pain measured using the NRS will be summarized by mean, standard deviation, and 95% 
confidence interval. 
o 
Demographics and medical history will be reported.  The continuous variable(s) will be summarized by 
mean and standard deviation. The categorical variable(s) will be summarized by frequencies and 
percentages. 
o 
Patient waveform preference at 3, 6, 12, 18, and 24 months post-permanent implant will be summarized 
by frequencies and percentages for participants who had multiple waveforms available to choose from.  
o 
Patient satisfaction at End of Trial System Evaluation 3, 6, 12, 18, and 24 months post-permanent 
implant will be summarized by frequencies and percentages. 
o 
Global improvement of the patient by using the Patient Global Impression of Change at End of Trial 
System Evaluation 3, 6, 12, 18, and 24 months will be summarized by frequencies and percentages. 
o 
Medication usage measured in decrease in chronic pain related medication intake since baseline at 3, 
6, 12, 18, and 24 months post-permanent implant by frequencies and percentages. 
o 
Battery consumption and/or recharging activities at 3, 6, 12, 18, and 24 months will be summarized by 
frequencies and percentages. 
o 
Stimulation Assessment measured by using the Stimulation Assessment Form at 3, 6, 12, 18, and 24 
months post-permanent implant will examine types of perceived stimulation as well as stimulation 
coverage and intensity. 
o 
Program information including amplitude, pulse width, frequency and electrode configuration will be 
summarized. 
o 
System information including device type, model number, lot number, and number of leads will be 
summarized. 
o 
Device, or procedure-related SAEs and non-serious AEs in subjects who receive permanent implant of 
the SCS stimulation system will be summarized by frequencies and percentages. 
 
6.1.4 
Missing Data 
 
Imputation methods will be used as appropriate to account for missing data, subject dropouts and 
withdrawals. If spurious data are discovered, these data will be excluded from analyses. Specific methods 
for handling missing data and reasons for exclusion of any data from analyses will be summarized where 
appropriate. 
 
6.1.1 
Subgroup Analysis 
Primary and secondary endpoints will be stratified by the subjects who had an ‘on-the-table trial’ and 
subjects who had a BurstDR trial. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 28 of 44 
 
 
Justification of Clinical Investigation Design 
The study is designed as a post-market, international, multicenter, interventional, prospective, single-arm 
study. The investigation will be conducted in approximately 30 centers in EMEA, US, Canada, and ANZ. 
The international and long-term follow-up study design will provide the real-world experience of multiple 
waveform enabled neurostimulator in patients with chronic, intractable pain of the trunk and/or limbs. 
 
Overall Sample Size 
The study aims to enroll 267 subjects based on assumptions drawn from experience with the Prodigy I 
study. Assuming a trial failure rate of 30%, and an attrition rate of 10% between baseline and trial, and 14% 
from permanent implant to 6-month follow-up, 168 subjects are projected to complete the permanent 
implant and 145 subjects are projected to complete the 6-month follow-up for primary endpoint evaluation. 
One hundred forty-five (145) subjects with evaluable NRS data at baseline and 6-month visit provides a 
95% confidence interval on the NRS change from baseline to 6-month with half interval width of 0.49 
assuming the standard deviation of the NRS change is 3.   
 
Timing of Analysis 
The analysis of primary and secondary endpoints will be conducted when 145 subjects have a permanent 
system implant and complete the 6-month follow-up endpoint evaluation. The final report will be conducted 
after all enrolled subjects either complete the 24-month visit or are discontinued from the study prior to the 
24-month visit. 
 
Interim Analysis 
An interim analysis of descriptive endpoints will be performed when all enrolled subjects either reach the 
12-month visit or are discontinued from the study prior to the 12-month visit.  
 
 
Statistical Criteria for Termination 
There are no statistical criteria for terminating this clinical investigation. 
 
Deviations from Statistical Plan 
If any deviations from the original statistical plan occur, such deviations will be documented in the clinical 
study report or statistical report containing the analysis results. 
7 
Risks and Benefits 
There are no additional risks of the clinical study beyond those associated with the implant and use of the 
CE/FDA-approved trial and permanent neurostimulation systems. Please refer to section 7.1.1 for the list 
of anticipated adverse events. 
 
Risks Associated with the Clinical Study Device 
7.1.1 
Anticipated Adverse Device Effects 
The use of a neurostimulation system involves risks. In addition to the risks commonly associated with 
surgery, below are listed the anticipated potential adverse effects with the use of a neurostimulation system: 
 
• 
Unpleasant sensations or motor disturbances, including involuntary movement, caused by 
stimulation at high outputs (if either occurs, turn off your EPG/IPG immediately) 
• 
Undesirable changes in stimulation, which may be related to cellular changes in tissue around the 
electrodes, or changes in electrode position  
• 
Changes in stimulation or reduced pain relief due to loose electrical connections   

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 29 of 44 
 
• 
Changes in stimulation or reduced pain relief due to lead failure 
• 
Stimulation in unwanted places or chest wall stimulation 
• 
Changes in stimulation or reduced pain relief due to lead migration 
• 
Epidural hemorrhage  
• 
Hematoma  
• 
Infection  
• 
Spinal cord compression  
• 
Paralysis from placement of a lead in the epidural space 
• 
Cerebrospinal fluid (CSF) leakage 
• 
Paralysis below the level of implant 
• 
Weakness, clumsiness and numbness below the level of implant  
• 
Pain below the level of implant 
• 
Persistent pain at the lead site 
• 
Persistent pain at the IPG site 
• 
Seroma (mass or swelling) at the IPG site 
• 
Seroma at the lead incision site 
• 
Allergic or rejection response to device/implant materials 
• 
Implant migration  
• 
Skin erosion around the implant 
• 
Loss of stimulation due to premature battery depletion/battery failure 
 
The St. Jude Medical™ MRI conditional neurostimulation systems are designed to minimize the potential 
adverse events that may cause patient harm. The following potential adverse events 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  
• 
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  
 
7.1.2 
Risks Associated with Clinical Investigation Assessments 
7.1.2.1 
Residual Risks Associated with the devices in this study, as identified in the risk analysis 
report 
 
The clinical risks associated with neurostimulation systems are well known. Any potential residual risks are 
considered to be outweighed by the benefits, and the overall residual risk was determined to be acceptable. 
Clinical evidence demonstrates acceptable safety and performance of the device under this post-market 
study. 
7.1.2.2 
Risks Associated with participation in the clinical study 
 
The risks involved with this study are comparable to those associated with the implant of any other 
commercially available neurostimulation system. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 30 of 44 
 
7.1.2.3 
Possible Interactions with Concomitant Medical Treatments and/or concurrent medical 
interventions 
 
Please refer to the Clinician’s Manual for information related to MRI compatibility and any possible 
interactions with concomitant medical treatment. 
 
7.1.2.4 
Steps that will be taken to control or mitigate the risks 
 
The Sponsor will employ measures throughout the course of this study to minimize these risks (e.g. clearly 
defined inclusion and exclusion criteria to ensure that only appropriate subjects are enrolled, proper 
consenting process, selection of investigational sites that have a sufficient level of clinical expertise, 
Investigator selection, appropriate training for all involved in the study activities etc.).  
 
Anticipated Benefits 
The information collected in this clinical study will be added to the current knowledge and understanding of 
treatment options for patients requiring a SCS treatment. 
 
Risk-to-Benefit Rationale 
Any undesirable side effects, under normal conditions of use, are considered acceptable risks when 
weighed against the performance of the device and benefits to the subject. 
 
8 
Requirements for Investigator Records and Reports 
 
Deviations from CIP 
A deviation is defined as an instance(s) of failure to follow, intentionally or unintentionally, the requirements 
of the CIP. The Investigator should not deviate from the CIP. 
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects; such non-compliance exposes subjects to unreasonable risks. Examples: failure to 
adhere to the inclusion/exclusion criteria, failure to perform safety assessments intended to detect adverse 
events. Investigators should seek to minimize such risks by adhering to the CIP. 
 
The PI must maintain accurate, complete, and current records, including documents showing the date of 
and reason for each deviation from the CIP. Relevant information for each deviation will be documented as 
soon as possible on the applicable CRF. The site will submit the CRF to the Sponsor. 
 
The PI is required to adhere to local regulatory requirements for reporting deviations to IRB/EC. 
 
Under emergency circumstances, deviations from the CIP to protect the rights, safety and well-being of 
subjects may proceed without prior approval of the Sponsor and the IRB/EC. Such deviations shall be 
documented and reported to the Sponsor and the IRB/EC as soon as possible. 
 
Safety Reporting 
Safety surveillance within this study and the safety reporting both performed by the Investigator and the 
Sponsor, starts as soon as the subject is enrolled in this study (date of signature of the informed consent). 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 31 of 44 
 
Safety surveillance and the safety reporting will continue until the last investigational visit has been 
performed, the subject is deceased, the subject/Investigator concludes his participation into the clinical 
investigation or the subject withdrawal from the clinical investigation. 
 
All adverse event data including deaths will be collected throughout the clinical investigation and will be 
reported to the Sponsor on a CRF. 
 
Adverse events will be monitored by the Investigator until they are adequately resolved or the subject has 
ended his/her participation in the trial, whichever comes first. The status of the subject’s condition should 
be documented and reported to the Sponsor at each visit. 
 
Per the CIP, the applicable reportable adverse event data including deaths will be collected throughout the 
clinical study and will be reported to the Sponsor through the EDC system. The Sponsor will ensure that all 
applicable events are reported to the relevant authorities as per regulations. The Investigator must notify 
the IRB/EC, if appropriate, in accordance with national and local laws and regulations, of the AEs reported 
to the Sponsor.  
 
Reportable events to Sponsor are considered:  
 
• 
All non-Serious Adverse Device Effects (procedure/device related) 
• 
All Serious Adverse Events (whether or not the event is considered device or procedure 
related)  
• 
Adverse events related to MRI scan 
 
All the above events will be reported to the Sponsor, as soon as possible, but 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 that requirement is more stringent. The date the site staff became aware that the event met 
the criteria for an SAE must be recorded in the source documents. 
 
For unexpected failure modes or unexpected adverse events, the site should follow their standard reporting 
practices for medical device reporting (MDR)/Vigilance reporting for medical devices per the regulations. 
8.2.1 
Subject Death 
Subject deaths will be documented and reported to the Sponsor on the applicable CRF as soon as possible 
after becoming aware of the event.  It is the Investigator’s responsibility to notify the IRB/EC per the IRB/EC 
policy. 
 
Should death occur, the Investigator is requested to record death information in the hospital records and 
immediately document the information on the Death CRF and submit to Sponsor through the electronic 
data capture (EDC) system deployed by Abbott. 
 
• 
All efforts to obtain the details about the circumstances surrounding the patient death should be 
made by the Investigator. 
• 
If a death event is an outcome of an adverse event, an AE CRF must be completed in addition to 
the Death CRF.  
• 
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.  
8.2.2 
Complaints 
During the study, the Investigator will be responsible for reporting all complaints. A complaint is defined as 
any written, electronic or oral communication that alleges deficiencies related to the identity, quality, 
durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 32 of 44 
 
 
If the complaint does not involve an AE, the Investigator must notify the Abbott Post Market Surveillance 
Department by submitting the information on the device via email to NMD CCoordinators@sjm.com or by 
phone +1 972-309-8000 as soon as possible after becoming aware of the complaint. This information will 
not be collected on a CRF for the study. 
 
If the complaint involves an AE, the Investigator must complete an AE CRF, including the information on 
the complaint and submit to Abbott as soon as possible and in accordance with the local laws and 
regulations.  
 
Source records 
Source documents will be created and maintained by the investigational site team throughout the clinical 
investigation. The data reported on the CRFs will be derived from, and be consistent with, these source 
documents, and any discrepancies will be explained in writing. 
 
Records Retention 
The Sponsor and the Principal Investigators will maintain the clinical investigation documents as required. 
Measures will be taken to prevent accidental or premature destruction of these documents. The Principal 
Investigator or the Sponsor may transfer custody of records to another person/party and document the 
transfer at the investigational site or the Sponsor’s facility, as appropriate. 
 
These documents must be retained by the investigational site for a period of 2 years after the conclusion 
of the clinical investigation and made available for monitoring or auditing by the Sponsor’s representative 
or representatives of the applicable regulatory agencies. 
 
All original source documents must be stored for the maximum time required by the regulations at the 
hospital, research institute, or practice in question. If original source documents can no longer be 
maintained at the site, the Investigator will notify the Sponsor.  
9 
Clinical Data Handling 
The Sponsor will be responsible for the data handling. The Sponsor and/or its affiliates will be responsible 
for compiling and submitting all required reports to governmental agencies. Data will be analyzed by the 
Sponsor and may be transferred to the Sponsor’s locations worldwide and/or any other worldwide 
regulatory authority in support of a market-approval application. 
 
Protection of Personally Identifiable Information 
Abbott respects and protects personally identifiable information collected or maintained for this clinical 
investigation. 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 investigation. All data will be secured against unauthorized access. 
 
Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, database cleaning, and 
issuing and resolving data queries. If appropriate, the DMP may be updated throughout the clinical 
investigation duration. All revisions will be tracked and document controlled. 
 
Subject data will be captured in a validated electronic data capture (EDC) system hosted by the Sponsor. 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system deployed 
by Abbott. An electronic audit trail will be used to track any subsequent changes of the entered data. 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 33 of 44 
 
 
 
Document and Data Control 
9.3.1 
Traceability of Documents and Data 
The Investigator will ensure accuracy, completeness legibility and timeliness of the data reported to the 
Sponsor on the CRFs and in all required reports. 
9.3.2 
Recording Data 
The CRF will be reviewed by the authorized site personnel. An appropriate comment will be provided to 
explain changes to data reported on the CRF. 
Source documents will be created and maintained by the investigational site team throughout the clinical 
study.  The data reported in the EDC will be derived from, and be consistent with, these source documents, 
and any discrepancies will be explained in writing.  
10 Monitoring 
Centralized monitoring will occur through routine internal data review. This monitoring is designed to 
identify missing and inconsistent data, data outliers, and potential CIP deviations that may be indicative of 
site non-compliance. On-site monitoring may occur at the discretion of the Sponsor. 
11 Compliance Statement 
 Statement of Compliance 
This clinical investigation will be conducted in compliance with the most current regional and local laws and 
regulations. Principles of Good Clinical Practice will be followed as based on the most current version of 
the World Medical Association (WMA) Declaration of Helsinki. 
 
The Investigator will sign a Clinical Trial Agreement and agrees to be compliant with it. The Investigator will 
not start enrolling subjects or requesting informed consent from any subject prior to obtaining IRB/EC 
approval and relevant Regulatory Authority approval, if applicable, and authorization from the Sponsor in 
writing for the clinical investigation. If additional requirements are imposed by the IRB/EC or relevant 
Regulatory Authority, those requirements will be followed. If any action is taken by an IRB/EC or a relevant 
Regulatory Authority with respect to the clinical investigation, that information will be forwarded to the 
Sponsor. 
 
For OUS sites; As the Sponsor, Abbott has taken up general liability insurance in accordance with the 
requirements of the applicable local laws. An appropriate Abbott country representative will be utilized to 
understand the requirements for the type of insurance that will be provided for subjects, and such 
information will be incorporated into the site informed consent, as applicable. If required, additional subject 
coverage or a clinical investigation specific insurance will be provided by the Sponsor. 
 Quality Assurance Audits and Regulatory Inspections 
The Investigator and/or delegate should contact the Sponsor immediately upon notification of a regulatory 
authority inspection at the site. A monitor or designee will assist the Investigator and/or delegate in 
preparing for the audit. The Sponsor may perform quality assurance audits, as required. 
 
The Principal Investigator or institution will provide direct access to source data during and after the clinical 
investigation for monitoring, audits, IRB/EC review and regulatory authority inspections, as required. The 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 34 of 44 
 
Principal Investigator or institution will obtain permission for direct access to source documents from the 
subject, hospital administration and national regulatory authorities before starting the clinical investigation. 
 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 monitor or designee 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 investigation, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the Investigator’s participation in the clinical investigation. In case of termination, the Sponsor will 
inform the responsible regulatory authority, as required, and ensure that the IRB/EC is notified, either by 
the Principal Investigator or by the Sponsor. 
12 Suspension or Premature Termination of the Clinical Investigation 
The Sponsor reserves the right to terminate the clinical investigation at any stage, with appropriate written 
notice to the Investigators, IRB/ECs and relevant Regulatory authorities, if required.  
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate participation 
in a clinical investigation at the investigational sites for which they are responsible. The Investigators will 
follow the requirements specified in the Clinical Trial Agreement.  
 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation or when so instructed 
by the IRB/EC or regulatory authority, the Sponsor may suspend the clinical investigation while the risk is 
assessed. The Sponsor will terminate the clinical investigation if an unacceptable risk is confirmed. If the 
Sponsor completes an analysis of the reasons for the suspension, implements the necessary corrective 
actions, and decides to lift the temporary suspension, the Sponsor will inform the Principal Investigators, 
IRB/EC, or regulatory authority, where appropriate, of the rationale, providing them with the relevant data 
supporting this decision. Approval from the IRB/EC or regulatory authority, where appropriate, will be 
obtained before the clinical investigation resumes. If subjects have been informed of the suspension, the 
Principal Investigator or authorized designee will inform them of the reasons for resumption. 
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual investigational 
site in the interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing resources 
to fulfill the obligations from the CIP and existing agreements for following up the subjects enrolled in the 
clinical investigation, and the Principal Investigator or authorized designee will promptly inform the enrolled 
subjects at his/her investigational site, if appropriate. 
13 Clinical Investigation Conclusion 
The clinical investigation will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to Investigators or the Sponsor has provided formal 
documentation of clinical investigation closure  

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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14 Publication Policy 
Publications or presentations of clinical investigation methods or results will adhere to Abbott’s publication 
policy, which is based on Good Publication Practices and International Committee of Medical Journal 
Editors (ICMJE) guidelines. A copy of the policy will be provided upon request of the Investigator. 
 
15 Reporting Results on ClincalTrials.gov Website 
The clinical investigation will be registered on ClinicalTrials.gov. A full report of the pre-specified outcomes, 
regardless of the results, will be made public through the ClinicalTrials.gov website no later than 12 months 
after clinical investigation completion, as required by section 801 of the Food and Drug Administration (FDA) 
Amendments Act.  
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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Appendix A: ABBREVIATIONS  
Abbreviation 
Term 
ADE 
AE 
ANZ 
BLE 
CA 
CIP 
CRF 
CSF 
DMP 
DRG 
EC 
eCRF 
EDC 
EMEA 
EPG 
EQ5D 
FDA 
GP 
ICMJE 
IFU 
IPG 
IRB 
ISB 
MOS 
MP 
MRI 
MTS 
NRS 
OUS 
PCS 
PGIC 
PHQ-9 
PI 
PNfS 
PNS 
PRO 
PROMIS 
PVD 
SADE 
SCS 
SJM 
SAE 
STAI 
TSK 
WMA 
Adverse Device Effect 
Adverse Event 
Australia – New Zealand 
Bluetooth® Low Energy 
Competent Authority 
Clinical Investigational Plan 
Case Report Form 
Cerebrospinal Fluid 
Data Management Plan 
Dorsal Root Ganglion 
Ethics Committee 
Electronic Case Report Form 
Electronic Data Capture 
Europe, Middle East, Africa 
External Pulse Generator 
Euro Qol 5- Dimensions 
Food and Drug Administration 
General Practitioner 
International Committee of Medical Journal Editors 
Instructions for Use 
Implantable Pulse Generator 
Institutional Review Board 
Investigator Site Binder 
Medical Outcome Study 
Monitoring Plan 
Magnetic Resonance Imaging 
Multiprogram Trial Stimulator 
Numeric Rating Scale 
Outside United States 
Pain Catastrophizing Scale 
Patient Global Impression of Change 
Patient Health Questionnaire - 9 
Principal Investigator 
Peripheral Nerve field Stimulation System 
Peripheral Nerve Stimulation 
Patient Reported Outcome 
Patient-Reported Outcome Measurement Information System 
Peripheral Vascular Disease 
Serious Adverse Device Effect 
Spinal Cord Stimulation 
St. Jude Medical 
Serious Adverse Event 
State Trait Anxiety Inventory 
Tampa Scale for Kinesiophobia 
World Medical Association 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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Appendix B: CIP Revision History 
This CIP may be amended as appropriate by the Sponsor. Rationale will be included with each amended 
version in the revision history table below. The version number and date of amendments will be 
documented. 
 
The acknowledgement of the amended CIP by the Coordinating Investigator (if applicable) and the Principal 
Investigators will be collected on the signature pages. 
 
IRB/EC and relevant Regulatory Authorities, if applicable, will be notified of amendments to the CIP. 
 
Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
Not Applicable 
A 
24 May 2015 
First release of CIP 
NA 
Amendment 1 
B 
14 Nov 2016 
Amended version to 
included changes 
mentioned in the ‘details’ 
section. 
- 
Implementation 
wording new CIP 
template 
- 
The Patient 
Reported 
Outcomes are no 
longer requested 
at every study visit.  
- 
The visit windows 
were adapted as 
of the 6-month visit 
(60 days) 
- 
There no longer a 
maximum 
timeframe between 
the end of trial 
system evaluation 
and permanent 
implant 
- 
There is no longer 
a need to printout 
the programming 
parameters record 
after the 
permanent implant 
procedure 
- 
US region included 
- 
Inclusion/Exclusion 
criteria changed 
and/or re-worded 
- 
Sample size 
increased to 267 
- 
Use of MTS is 
added for on-the-
table trials only 
- 
The use of the 
Global Pain Scale 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 38 of 44 
 
is no longer 
applicable 
- 
The NRS changed 
to 1 question only 
- 
The risk section 
has been 
reworded 
- 
There will be a sub 
analysis by 
subjects who had 
‘on-the-table trials, 
tonic trials and 
Burst trials. 
- 
In case the subject 
requires 
reprogramming 
during follow-up 
visits, it should be 
performed prior to 
printout of the 
programming 
parameters record 
and any study visit 
assessments.   
Amendment 2 
C 
15 Dec 2017 
Amended to improve 
readability and clarity of 
measures used in the 
study. Additionally, MRI 
data collection was added 
(if scan conducted as 
standard of care)  
- 
Revised 
introduction to 
clarify study 
rationale 
- 
Clarified 
description of 
collected 
measures  
- 
Added language 
regarding MRI 
data collection  
- 
Reformatted 
references 
- 
Changed SJM to 
Abbott where 
appropriate 
Amendment 3 
D 
10 OCT 
2018 
Amended to include 
measure collection at 18 
months. 
- 
EQ-5D, PCS, 
STAI, PHQ-9, 
TSK, MOS Sleep 
Scale, and 
PROMIS physical 
function scales 
have been added 
to 18-month visit 
- 
Reference to a 
tonic-trial subgroup 
analysis removed 
because no such 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 39 of 44 
 
group can exist 
according to 
protocol rules 
- 
3-day timeframe 
for SAE reporting 
specified 
- 
Various 
administrative 
corrections and 
clarifications 
Amendment 
3.1 
E 
19 NOV 
2018 
Addition prior to 
implementing Amendment 
3 includes programming 
information and stimulation 
assessment at unscheduled 
visit.  
- 
Programming 
information and 
stimulation 
assessment will be 
collected at 
unscheduled visit if 
reprogramming 
occurs. 
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 40 of 44 
 
Appendix C: Definitions 
 
Non-study Specific Definitions 
 
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 clinical investigation. 
 
This definition includes events related to the medical device or procedures. 
 
Serious Adverse Event (SAE) 
 
An adverse event that led to: 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o 
A life-threatening illness or injury OR 
o 
A permanent impairment to a body structure or a body function OR 
o 
An in-patient or prolonged hospitalization OR 
o 
A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function OR 
o 
A malignant tumor  
• 
Fetal distress, fetal death or a congenital abnormality or birth defect 
 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not considered 
a serious adverse event. 
 
Adverse Device Effect (ADE) 
 
An adverse event related to the use of a medical device. 
 
This definition includes adverse events 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. 
 
Serious Adverse Device Effect (SADE) 
 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 41 of 44 
 
Appendix D: Bibliography 
1. de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal cord 
stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes Complications. 2009; 
23(1): 40-45. 
 
2. 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. 
 
3. 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. 
 
4. Leveque JC, Villavicencio AT, Bulsara K, Rubin L, Gorecki J. Spinal cord stimulation for failed back 
surgery syndrome. Neuromodulation. 2001; 4(1); 1-9. 
 
5. 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; 30(12); 1412-1418. 
 
6. 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. 
 
7. 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. 
 
8. 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. 
 
9. Amann W, Berg P, Gersbach P, Gamain J, Raphael JH, Ubbink DT. Spinal cord stimulation in the 
treatment of non-reconstructable stable critical leg ischemia: results of the European Peripheral Vascular 
Disease Outcome Study (SCS-EPOS). Eur J Vasc Endovasc Surg. 2003; 26(3): 280-286. 
 
10. 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. 
 
11. Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back 
and leg pain/failed back surgery syndrome: results of a systematic review and meta-analysis. J Pain 
Symptom Manage. 2006; 31: S13-S19. 
 
12. De Ridder D, Vanneste S, Plazier M, Vancamp T. Mimicking the brain: evaluation of St Jude Medical’s 
Prodigy Chronic Pain System with Burst Technology. Expert Rev Med Devices. 2015; 12(2): 143-150. 
13. Courtney P, Espinet A, Mitchell B et al. Improved pain relief with burst spinal cord stimulation for two 
weeks in patients using tonic stimulation: results from a small clinical study. Neuromodulation. 2015; 18(5): 
361-366. 
14. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb 
and back pain. World Neurosurg. 2013; 80(5): 642-649. 
15. de Vos CC, Bom MJ, Vanneste S, Lenders MWPM, De Ridder D. Burst spinal cord stimulation evaluated 
in patients with failed back surgery and painful diabetic neuropathy. Neuromodulation. 2014; 17: 152-159 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 42 of 44 
 
16. Deer T, Slavin KV, Amirdelfan K et al. Success using neuromodulation with burst (SUNBURST) study: 
results from a prospective, randomized controlled trial using a novel burst waveform. Neuromodulation. 
2017; E-pub ahead of print. doi: 10.1111/ner.12698 
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 43 of 44 
 
Appendix E: Case Report Form 
The CRF’s will be kept under a separate cover and are available upon request.  
 
 

Study Document No: SJM-CIP10145 Ver. E 
Study Name: TRIUMPH 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 44 of 44 
 
Appendix F: Sample Informed Consent 
The study specific informed consent will be kept under a separate cover and is available upon request