DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
Phase: NA
Conditions: Chronic Pain
Sponsor: MedtronicNeuro

DTM™-LE SCS Study 
Clinical Investigational Plan V2.0 
Approval Date 25-FEB-2021 
NCT04601454 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Differential-Target Multiplex Low Energy Spinal 
Cord Stimulation (DTM-LE SCS) Study 
Clinical Investigation Plan Identifier MDT20042 
Study Product Name Medtronic Intellis™ with AdaptiveStim™ 
Neurostimulation System 
Sponsor Medtronic, Inc. 
Medtronic Neuromodulation 
700 Central Ave NE 
Minneapolis, MN, 55432 
U.S.A. 
+1-763-514-4000 
Document Version 2.0 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 
 

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

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Table of Contents 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
Table of Figures ......................................................................................................................... 8 
Table of Tables .......................................................................................................................... 8 
2. 
Glossary .............................................................................................................................. 9 
3. 
Synopsis ........................................................................................................................... 10 
4. 
Introduction ..................................................................................................................... 16 
4.1 Background ........................................................................................................................... 16 
4.2 Purpose ................................................................................................................................. 18 
5. 
Objectives ........................................................................................................................ 18 
5.1 Objectives ............................................................................................................................. 18 
5.1.1 
Primary Objective ................................................................................................................ 18 
5.1.2 
Secondary Objective ........................................................................................................... 18 
 
 
6. 
Study Design .................................................................................................................... 19 
6.1 Duration ................................................................................................................................ 20 
6.2 Rationale ............................................................................................................................... 20 
7. 
Product Description.......................................................................................................... 21 
7.1 General ................................................................................................................................. 21 
7.2 Manufacturer ......................................................................................................................... 21 
7.3 Packaging .............................................................................................................................. 21 
7.4 Intended Population ............................................................................................................... 21 
7.5 Product Use ........................................................................................................................... 22 
7.6 Product Training Materials ...................................................................................................... 22 
7.7 Product Return ...................................................................................................................... 22 
7.8 Product Accountability ............................................................................................................ 22 
8. 
Study Site Requirements ................................................................................................. 22 
8.1 Investigator/Investigation Site Selection .................................................................................. 22 
8.2 Study Site Activation .............................................................................................................. 23 
8.3 Role of the Sponsor Representatives ....................................................................................... 23 
9. 
Selection of Subjects ........................................................................................................ 24 

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9.1 Study Population .................................................................................................................... 24 
9.2 Subject Enrollment ................................................................................................................. 24 
9.3 Inclusion Criteria .................................................................................................................... 24 
9.4 Exclusion Criteria ................................................................................................................... 25 
10. 
Study Procedures .......................................................................................................... 26 
10.1 Schedule of Events ................................................................................................................. 26 
10.2 Data Collection ...................................................................................................................... 27 
10.3 Visit Windows ........................................................................................................................ 28 
10.4 Subject Screening .................................................................................................................. 29 
10.5 Prior and Concomitant Medications/Therapies .......................................................................... 29 
10.6 Subject Consent ..................................................................................................................... 30 
10.7 Enrollment/Baseline ............................................................................................................... 31 
10.8 Device Trial ........................................................................................................................... 32 
10.8.1 
Device Trial Start (≤ 20 days post-Baseline) ........................................................................ 32 
10.8.2 
Device Mid-Trial (If necessary) ............................................................................................ 32 
10.8.3 
Device Trial End ................................................................................................................... 33 
10.9 Device Implant (≤ 35 days post Device Trial End) .................................................................... 33 
10.10 
Device Activation (Day 0; 9-16 days after implant) ........................................................... 34 
10.11 
Post Implant Telephone Calls .......................................................................................... 34 
10.12 
Post-Implant Scheduled Visits .......................................................................................... 35 
10.12.1 
1-Month Visit .................................................................................................................. 35 
10.12.2 
3-Month Visit .................................................................................................................. 35 
10.12.3 
6-Month Visit .................................................................................................................. 36 
10.12.4 
12-Month/Final Study Visit ............................................................................................. 36 
10.13 
Unscheduled Visits .......................................................................................................... 37 
10.14 
Device Interrogation ....................................................................................................... 37 
10.15 
Imaging ......................................................................................................................... 37 
10.16 
System Modification ........................................................................................................ 37 
10.17 
Assessment of Efficacy .................................................................................................... 38 
10.17.1 
Visual Analog Scale (VAS) ................................................................................................ 38 
 
 

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10.17.11 
Programming Parameters ............................................................................................... 41 
10.18 
Assessment of Safety ...................................................................................................... 41 
10.19 
Recording Data ............................................................................................................... 41 
10.19.1 
Case Report Form Data ................................................................................................... 41 
10.19.2 
Programming Parameter Data ........................................................................................ 42 
10.19.3 
Image Data ...................................................................................................................... 42 
10.20 
Deviation Handling ......................................................................................................... 42 
10.21 
Subject Exit, Withdrawal or Discontinuation ...................................................................... 43 
10.21.1 
Study Completed ............................................................................................................. 44 
10.21.2 
Lost to Follow-up ............................................................................................................ 44 
10.21.3 
Conditional Disengagement ............................................................................................ 44 
11. 
Risks and Benefits ........................................................................................................ 44 
11.1 Potential Risks ....................................................................................................................... 44 
11.1.1 
Foreseeable Risks ................................................................................................................ 45 
11.2 Risk Minimization ................................................................................................................... 46 
11.3 Potential Benefits ................................................................................................................... 47 
11.4 Risk-Benefit Rationale ............................................................................................................ 47 
12. 
Adverse Events and Device Deficiencies ...................................................................... 47 
12.1 Adverse Events ...................................................................................................................... 47 
12.2 Device Deficiency ................................................................................................................... 48 
12.3 Processing Updates and Resolution ......................................................................................... 48 
12.4 Definitions/Classifications ....................................................................................................... 48 
12.5 Reporting of Adverse Events ................................................................................................... 54 

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12.5.1 
Adverse Event and Device Deficiency Classification ........................................................... 54 
12.5.2 
Adverse Event and Device Deficiency Reporting Requirements ........................................ 55 
12.6 Subject Death ........................................................................................................................ 56 
12.7 Product Complaint Reporting .................................................................................................. 57 
13. 
Data Review Committees ............................................................................................. 58 
14. 
Statistical Design and Methods .................................................................................... 58 
14.1 General Aspects of Analysis .................................................................................................... 58 
14.1.1 
Analysis Sets ........................................................................................................................ 58 
14.1.2 
Handling Missing Data ........................................................................................................ 59 
14.1.3 
Multiplicity .......................................................................................................................... 59 
14.1.4 
Investigation Site Pooling .................................................................................................... 59 
14.2 Analysis Execution ................................................................................................................. 59 
14.3 Interim Analysis ..................................................................................................................... 59 
14.4 Primary Objective ................................................................................................................... 59 
14.4.1 
Hypothesis ........................................................................................................................... 59 
14.4.2 
Endpoint definition and derivation ..................................................................................... 60 
14.4.3 
Analysis Methods ................................................................................................................ 60 
14.4.4 
Determination of Subjects/Data for Analysis ..................................................................... 60 
14.5 Secondary Objective .............................................................................................................. 60 
14.5.1 
Hypothesis ........................................................................................................................... 60 
14.5.2 
Endpoint Definition and derivation .................................................................................... 60 
14.5.3 
Analysis Methods: ............................................................................................................... 61 
14.5.4 
Determination of Subjects/Data for Analysis ..................................................................... 61 
 
14.7 Safety assessment ................................................................................................................. 61 
14.8 Sample Size Justification ......................................................................................................... 62 
14.9 Minimization of Bias ............................................................................................................... 62 
15. 
Ethics ............................................................................................................................ 62 
15.1 Statement(s) of Compliance.................................................................................................... 62 
16. 
Study Administration .................................................................................................... 63 
16.1 Monitoring ............................................................................................................................. 63 

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16.1.1 
Monitoring Visits ................................................................................................................. 63 
16.2 Data Management .................................................................................................................. 63 
16.3 Direct Access to Source Data/Documents ................................................................................ 64 
16.4 Confidentiality ........................................................................................................................ 64 
16.5 Liability ................................................................................................................................. 65 
16.6 CIP Amendments ................................................................................................................... 65 
16.7 Record Retention ................................................................................................................... 65 
16.7.1 
Investigator Records ........................................................................................................... 65 
16.7.2 
Sponsor Records ................................................................................................................. 66 
16.8 Reporting Requirements ......................................................................................................... 67 
16.8.1 
Investigator Reports ............................................................................................................ 67 
16.8.2 
Sponsor Reports .................................................................................................................. 67 
16.9 Publication and Use of Information ......................................................................................... 68 
16.9.1 
Criteria for Determining Authorship ................................................................................... 68 
16.9.2 
Transparency ....................................................................................................................... 68 
16.10 
Suspension or Early Termination ...................................................................................... 69 
16.10.1 
Planned Study Closure .................................................................................................... 69 
16.10.2 
Early Termination or Suspension .................................................................................... 69 
16.10.3 
Procedures for Termination or Suspension .................................................................... 70 
17. 
References .................................................................................................................... 71 
18. 
Appendices ................................................................................................................... 72 
19. 
Version History ............................................................................................................. 72 
 
 
 

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Table of Figures 
Figure 10-1: Study Visit Diagram ................................................................................................................. 27 
 
Table of Tables 
Table 10-1: Data collection and study procedure requirements at subject visits ...................................... 28 
Table 10-2: Study Visit Target Windows ..................................................................................................... 29 
Table 12-1: AE and DD Definitions .............................................................................................................. 49 
Table 12-2: Adverse Event Classification Responsibilities .......................................................................... 55 
Table 12-3: Reporting Requirements .......................................................................................................... 56 
Table 14-1: Precision by Sample Size and Standard Deviation of VAS ....................................................... 62 
Table 16-1: Investigator Reports ................................................................................................................. 67 
 
 
 

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Study Design 
This is a prospective, multi-center, open-label, post-market study to evaluate 
the efficacy and energy use of a low energy DTM™ (DTM-LE) SCS therapy for 
pain relief. The study will be conducted in up to 15 sites in the United States.  
 
All eligible subjects will undergo an SCS Device Trial per labeling that includes 
intraoperative testing. If the final lead placements span 
 T8 to 
 T10 
after trial lead implant and patient flexion, DTM-LE stimulation will be 
programmed for pain relief and comfort. DTM-LE SCS will deliver different, 
simultaneously running signals within the range of FDA-approved device 
capabilities to 
 different locations between 
 T8 and 
 T10 vertebral 
levels. 
 
 to achieve successful pain 
relief, defined as a subject-reported assessment with ≥50% improvement in 
overall pain from baseline.  
 
After a successful DTM-LE SCS Device Trial, subjects will proceed with the 
standard of care to an implant of a Medtronic Intellis™ with AdaptiveStim™ 
rechargeable neurostimulator. Post-implant and after the wound has healed, 
the device will be activated and programmed to the DTM-LE SCS parameters.  
 
Device activation will be Day 0 for the study. Subjects will complete post-
implant visits at 1-, 3-, 6-, and 12-month. The primary endpoint will be 
evaluated at the 3-Month Visit. 
Sample Size 
Approximately 30 subjects are needed to provide data at 3-Month visit, with 
an estimated attrition of 40% between enrollment and implant and an 
estimated attrition of 10% between implant and 3-Month visit, up to 56 
subjects may be enrolled into the study. 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria:  
To be included in this study, a patient must meet the following inclusion 
criteria:  
1. 18 years of age or older 
2. Willing and able to provide signed and dated informed consent 

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3. Capable of comprehending and consenting in English 
4. Candidate per labeling for an SCS system (trial and implant) as an aid in 
the management of chronic, intractable pain of the trunk and/or limbs 
5. Has moderate to severe back and leg pain, as determined by the 
investigator, or designee 
6. Baseline VAS is ≥6 for overall pain 
7. Baseline VAS is ≥6 for back or leg pain 
8. ODI score of 21 to 80 out of 100 
9. On stable (no change in dose, route, or frequency) pain medications 
(prescribed and over-the-counter) being used specifically for back and leg 
pain, as determined by the investigator or designee, for at least 28 days 
prior to enrolling in the study 
10. Willing and able to comply with all study procedures and visits 
11. Willing and able to not increase their pain medications (prescribed and 
over-the-counter) being used specifically for back and leg pain through 
the 3-month visit 
12. Able to differentiate between pain associated with the indication for SCS 
implant and other types of pain, as determined by the investigator, or 
designee 
 
Exclusion Criteria:  
To be included in this study, a patient must not meet any of the following 
exclusion criteria:  
1. Previously trialed or implanted with spinal cord stimulator, peripheral 
nerve stimulator, or an implantable intrathecal drug delivery system 
2. Expected to be inaccessible for follow-up 
3. Current diagnosis of moderate to severe central lumbar spinal stenosis 
with symptomatic neurogenic claudication as determined by the 
investigator, or designee 
4. Currently enrolled or planning to enroll in an interventional clinical study 
that could potentially confound the study results (co-enrollment in an 
interventional study is only allowed when documented pre-approval is 
obtained from the Medtronic study manager, or designee) 
5. If female, is pregnant or is of child-bearing potential and unwilling to use 
a medically acceptable form of birth control during the study 
6. Has untreated major psychiatric comorbidity, as determined by the 
investigator, or designee 
7. Serious drug-related behavioral issues (e.g. alcohol dependency, illegal 
substance abuse), as determined by the investigator, or designee 

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8. Unable to achieve supine or prone position 
9. If subject is classified as vulnerable or requires a legally authorized 
representative (LAR) 
 
Additional Inclusion Criteria (to be evaluated at Device Trial/Implant): 
1. Final lead placements span 
 T8 to 
 T10 after patient flexion at 
Device Trial  
2. The subject reports ≥ 50% improvement in overall pain relief at the 
Device Trial End Visit  
3. Final lead placements span 
 T8 to 
 T10 at Device Implant  
Study Procedures 
and Assessments 
Specific data and procedure requirements per visit are summarized in the 
Procedure Table.  
Study Visits 
• 
Enrollment/Baseline Visit 
• 
Device Trial Start Visit 
• 
Device Mid-Trial Visit (If necessary) 
• 
Device Trial End Visit  
• 
Device Implant Visit 
• 
Device Activation Visit 
• 
1-Month Visit  
• 
3-Month Visit 
• 
6-Month Visit 
• 
12-Month/Final Study Visit 
Enrollment/Baseline Visit: 
Subjects are considered enrolled at the time the study-specific informed 
consent (and HIPPA or other data protection authorization as required by 
local regulations) is signed. Subjects in compliance with inclusion/exclusion 
criteria will be eligible to participate. A VAS score for overall (back and leg), 
back, and leg pain will be collected. Subjects that do not have a VAS ≥ 6 cm 
for overall pain and a VAS ≥ 6 cm for either back or leg pain will be exited 
from the study. 
 
 Subjects that meet eligibility 
criteria will be scheduled for a device trial and the following will be collected: 
 
 
 
 
 
 
• 
Demographics 
• 
Medical/surgical history 
• 
Pain medications 
 

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The baseline visit can be a stand-alone visit or can be performed on the same 
day as the Device Trial Start Visit. 
 
Device Trial Start Visit (≤ 20 days post Baseline Visit) 
Subjects will be implanted with two compact percutaneous leads per labeling.  
If subjects have leads spanning the 
 T8 to 
 T10 vertebral levels after 
trial lead implantation and flexion, they will continue in the study and DTM-LE 
stimulation will be programmed for pain relief and comfort. Imaging, device 
information, and programming parameters will be collected.   
 
Device Mid-Trial Visit (If necessary) 
Subjects will be called during the device trial by a sponsor representative 
(e.g., field clinical engineer) to assess effectiveness of stimulation parameters 
and facilitate re-programming, as needed. An in clinic mid-trial visit may be 
performed, if necessary, for issues (such as inadequate pain relief that 
requires in-clinic re-programming/device interrogation) that cannot be 
addressed over the phone. Imaging and programming parameters will be 
collected, if performed. 
 
Device Trial End  
Subjects will be trialed per standard of care and within device labeling limits 
while enrolled into the study. Subjects will come in for the Device Trial End 
Visit within 7 days of the device trial start. At the Device Trial End Visit, if a 
subject has ≥ 50% improvement in overall pain with DTM-LE SCS 
programming, they will have their trial leads explanted and will proceed to 
implant. If a subject does not have ≥ 50% improvement overall pain relief 
with DTM-LE SCS programming, they will be treated per standard of care and 
exited from the study. The outcome (i.e., success or failure) of the trial for 
those subjects that did not have a successful DTM-LE SCS trial will be 
recorded. Programming parameters will be collected. Images will be collected 
if performed. Trial lead explant must occur within 10 days of trial lead 
implant. 
 
Implant (≤ 35 days post end of device trial) 
Subjects who were DTM-LE SCS programming responders during the device 
trial and who met all eligibility criteria will be implanted with an Intellis™ with 
AdaptiveStim™ neurostimulation system including two compact 
percutaneous leads per labeling. Subjects who have leads spanning the 
 
T8 to 
 T10 vertebral bodies will continue in the study. Imaging, 
programming parameters and device information will be collected. The 
stimulator will be “OFF” when the subject leaves this visit. 
 
Device Activation Visit (9 – 16 days post implant)  
The Device Activation Visit will take place 9-16 days after implant, pending 
wound healing. The stimulator will be turned “ON” at this visit and subjects 

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will be programmed to DTM-LE SCS settings. Programming parameters will be 
collected. Imaging will be collected, if performed. 
 
Post-Implant Telephone Calls 
Subjects will be called weekly by delegated study site personnel post-device 
activation to assess their pain relief status up to the 3-Month Visit and then 
monthly following the 3-Month Visit. If an in-clinic visit falls on the week or 
month of a scheduled telephone call, the call will not be performed. If the 
subject reports inadequate pain relief, they may be contacted by a sponsor 
representative (e.g., field clinical engineer) to assess for re-programming 
and/or come in for an unscheduled visit. 
 
Post Implant 1-, 3-, 6-, and 12-Month/Final Study Visit (±15 days post Device 
Activation) 
Post implant visits will occur at 1-, 3-, 6-, and 12-month post device 
activation. At the 1-month visit, stimulation threshold testing will be 
performed in the upright and supine positions for each programmed group.  
Imaging and programming parameters will be collected through the 12-
Month/Final Study Visit, if re-programming or imaging occurs.  
 
The following measures will be collected during follow-up: 
• 
VAS (all follow-up visits) 
 
 
Safety Assessments 
This study will collect and characterize all device-related, therapy-related, and 
procedure-related adverse events and device deficiencies from the Device 
Trial Start Visit until study exit. 
Statistics 
The Confidence Intervals for One Mean module in statistical software PASS 11 
was used to provide the following sample size justification: a sample size of 
30 subjects produces a two-sided 95% confidence interval with a distance 
from the mean to the limits that is equal to 0.97 when the estimated 
standard deviation is 2.6.  
 
With estimated attrition of 40% between enrollment and implant and 10% 
between implant and 3-Month, to achieve approximately 30 subjects at 3-
Month visit, up to 56 subjects may be enrolled into the study. 
 
For the primary objective, the mean change of overall pain intensity from 
baseline to 3-Month visit will be reported with a 95% confidence interval (CI). 
Primary analysis will use per-protocol analysis set who are implanted, follow 
DTM-LE SCS programming, and provide data at both baseline and 3-Month 
visits. Sensitivity analyses will use completers analysis set who are implanted 
and provide data at both baseline and 3-Month visits regardless of 

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programming patterns, as well as implanted analysis set with multiple 
imputation (MI) for missing data.  
 
The secondary objective will be analyzed with descriptive statistics from 
Device Trial to 12-Month visit. Subjects who contribute to follow-up visits will 
be included in the analysis.  
 
 
 
Adverse events and device deficiencies will be summarized using summary 
tables displaying the frequency and percentages. Adverse events will be 
summarized by seriousness as well. 
 
4. Introduction 
4.1 Background 
Spinal Cord Stimulation (SCS) uses electrical signals to modulate the nervous system, resulting in pain 
relief. These signals are defined by programs comprised of parameter settings for the amplitude, 
frequency, pulse width, active electrodes, current distribution, and therapy cycle. The parameters can 
be modulated to produce programs for purposes such as improved pain relief and/or comfort, reduced 
side-effects, increased energy efficiency, or delay or prevent therapy habituation. There are multiple 
hypotheses to account for the mechanisms of action of different SCS parameters. Non-rechargeable SCS 
systems have a finite energy capacity that limits the parameter settings available to meet an acceptable 
implant longevity. Introduction of therapy cycling, alternating periods of therapy turned ON and OFF, 
may maintain or even improve outcomes associated with SCS while preserving battery life.1,2, 3, 4 Recent 
studies have shown that effective pain relief of traditionally higher energy programs can be maintained 
at lower energy doses through reduction of parameters (frequency, pulse width, amplitude).5,6,7. 
Development of lower energy SCS programs would increase recharge interval or reduce daily recharge 
duration in rechargeable cell (RC) systems and enable an acceptable device longevity in non-
 
1 Shatin D, Mullett K, Hults G. Totally Implantable Spinal Cord Stimulation for Chronic Pain: Design and Efficacy. PACE 9 (1986) 577-583 
2 Provenzano D, Yu C, Verrills P, Guirguis M, Harrison N, Bradley K. Pulse Dosing of 10 kHz Paresthesia-Independent Spinal Cord Stimulation 
Provides Same Efficacy with Substantial Reduction of Device Recharge Time. Abstract 2019 
3 Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as 
Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation 2019; 
22:1 190-193 
4 Deer TR, Patterson DG, Baksh J, Pope JE, Metha P, Raza A, Agnesi F, Chakravarthy K. Novel Intermittent Dosing Burst Paradigm in Spinal Cord 
Stimulation. [Article in Press] Neuromodulation 2020 
5 Thomson SJ, Tavakkolizadeh M, Love-Jones S, Patel NK, Gu JW, Bains A, Doan Q, Moffitt M. Effects of Rate on Analgesia in Kilohertz Frequency 
Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation 2018 21:1 (67-76) 
6 Paz-Solis J, Thomson S, Jain R, Chen L, Huertas I, Doan Q. Customization of Neural Dose: Real-World Data Demonstrating The Relationship 
Between Frequency, Pulse-Width, And Amplitude In Achieving Sub-Perception SCS Pain Relief (The HALO Study). Abstract 2019 
7 Verdolin MH. Case Series of Subperception SCS trial of multiple energy doses at T9-10 for FBSS. NANS Abstract 2020 

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rechargeable systems for programs with higher frequency and/or pulse-width settings. Evidence is 
needed to guide best programming practice as well as future parameter options. 
 
Understanding of frequency modulation has been expanded from traditional stimulation at a range of 
around 40 – 100 Hz,8 to stimulation in the range of hundreds to thousands of cycles-per-second or with 
burst patterns,9,10 ,11  where the therapy provides pain relief while producing reduced or no sensation of 
stimulation (aka paresthesia). While sub-paresthesia threshold stimulation was initially shown to be 
effective using higher frequency and higher energy consumption parameters, the PROCO study 
demonstrated that frequencies from 10 kHz down to 1 kHz, at 50% paresthesia perception threshold, 
and with titration of pulse width and amplitude, could provide pain relief while reducing the mean 
charge per second by about a third.5 This observation was extended with the HALO study, from 1 kHz 
down to 10 Hz, and the “rule of neural dosing” was introduced to describe the increase in pulse width 
and amplitude titration required with lower frequencies.6 The Hi Lo Sham study similarly showed that 
targeted, sub-perception therapy produced similar pain relief for both a high and low energy program 
that were both superior to sham during a 3-day trial period.7 
 
Therapy cycling is another strategy that has long been employed with traditional SCS where automatic 
on/off cycling mode has shown greater pain relief than patients stimulated continuously.1 It is now being 
studied with otherwise higher energy consuming therapies. The 10kHz SCS Pulse Dosing study 
demonstrated that subthreshold, 10 kHz, 30 μs therapy could be cycled off from 50 up to 97% of the 
time and still maintain pain relief in a significant number of patients at 3 months.2  The Burst SCS 
Microdosing study showed no difference in pain relief between the BurstDR waveform, Burst with 5 s 
on:5 s off, and Burst with 5 s on:10 s off.3 This was expanded upon with the BOLD study, which tested 
cycling in 30 s increments from a 1:12 to a 1:3 paradigm and showed most patients were using the 1:12 
option at 6 months.4  
 
The understanding of mechanisms of action for SCS has recently been expanded to include the concept 
of glial cell modulation. Neural-glial cell interaction has been implicated in development of the chronic 
pain state.12,13,14 Additionally, glia are electrically responsive cells in the spinal cord and outnumber 
neurons by 12:1.15 The Differential Target Multiplexed™ waveform was designed to target neural and 
glial cells. Preclinical research suggests the ability of DTM™ SCS to impact neural-glial cell interaction, 
showing statistically significant reversal of pain behaviors compared to either low or high frequency 
 
8 Sharan A, Cameron T, Barolat G. Evolving patterns of spinal cord stimulation in patients implanted for intractable low back and leg pain. 
Neuromodulation. 2002;5(3):167–79. doi:10.1046/j.1525-1403.2002.02027.x. 
9 De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World neurosurgery . 
2013; 80( 5): 642-649.e1. 
10 Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz highfrequency spinal cord stimulation for 
patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain medicine 2013; Electronic Publication Date: 5 
Dec 2013. 
11 De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord stimulation: Toward paresthesia-free pain suppression. 
Neurosurgery.2010; 66: 986-990. 
12 Milligan ED, Watkins LR. Pathological and protective roles of glia in chronic pain. Nat Rev Neurosci. 2009 Jan;10(1):23-36. 
13 Vallejo R, Tilley DM, Vogel L, Benyamin R. The role of glia and the immune system in the development and maintenance of neuropathic 
pain. Pain Pract. 2010 May-Jun;10(3):167-84. 
14 De Leo JA, Tawfik VL, LaCroix-Fralish ML. The tetrapartite synapse: Path to CNS centralization and chronic pain. Pain. 2006; 122:17-21. 
15 Ruiz-Sauri A., Orduña-Valls J.M., Blasco-Serra A. et al. Glia to neuron ratio in the posterior aspect of the human spinal cord at thoracic 
segments relevant to spinal cord stimulation. Journal of Anatomy, vol. 235, no. 5, 2019, pp. 997-1006. 

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6. Study Design 
This is a prospective, multi-center , open-label, post-market study to evaluate the efficacy and energy 
use of a low energy DTM™ (DTM-LE) SCS therapy for pain relief. The study will be conducted in up to 15 
sites in the United States.  
Up to 56 subjects are expected to be enrolled in the study to allow for approximately 30 subjects to 
complete the 3-Month Visit. All implanted subjects with devices activated will be followed through the 
12-Month/Final Study Visit.  The study sample size accounts for expected attrition; therefore, subjects 
who discontinue prior to study completion will not be replaced. 
All eligible subjects will undergo an SCS Device Trial per labeling that includes intraoperative testing. If 
the final lead placements span 
 T8 to 
 T10 after trial lead implant and patient flexion, DTM-LE 
stimulation will be programmed for pain relief and comfort. DTM-LE SCS will deliver different, 
simultaneously running signals within the range of FDA-approved device capabilities at 
 unique 
locations between 
 T8 and 
 T10 vertebral levels and will be programmed within the following 
limits: 
 
 
 
 

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on 
 
 
  
After a successful DTM-LE SCS Device Trial, subjects will proceed with the standard of care to an implant 
of a Medtronic Intellis™ with AdaptiveStim™ rechargeable neurostimulator. Approximately 9-16 days 
post-implant, after the wound has healed, the device will be activated and programmed using DTM-LE 
SCS.  
Device activation will be Day 0 for the study. Subjects will complete follow-up visits at 1-, 3-, 6-, and 12-
months. The primary endpoint will be evaluated at the 3-Month visit. 
Subjects may be enrolled at approximately 15 study sites in the US, with no more than 10 subjects 
enrolled at any individual study site. Enrollment will be competitive across study sites. The per-study site 
enrollment cap may be increased upon Sponsor approval. 
6.1 Duration 
The expected total study duration is approximately 2 years.  Enrolled subjects will have up to 10 
scheduled visits including Baseline, Device Trial (up to 3 visits), Device Implant, Device Activation, Post 
Implant (1-month, 3-month, and 6-month visit) and Final Study (12-month visit).  Subjects' participation 
in the study is expected to last up to 14 months from enrollment (>1 month for screening, baseline, 
implant and recovery; 12 months of required follow-up until study closure); however, this may vary 
based on the time between the device trial end and device implant.   
6.2 Rationale 
This study will evaluate the efficacy and energy use of a low energy DTM™ (DTM-LE) SCS therapy for 
pain relief. The data collected will provide insight into the efficacy of programming settings that utilize 
energy reducing strategies and has the potential to shape future clinical practices that may reduce 
recharge burden in rechargeable systems and enable an acceptable device longevity in non-
rechargeable systems. Furthermore, the study may contribute evidence to support the evolution and 
flexibility of the DTM™ SCS therapy. The study design builds on existing pre-clinical and clinical evidence 
supporting the use of a DTM™ waveform and facilitates additional data collection to further understand 
the use of a low energy DTM™ waveform in the management of pain relief for subjects with chronic, 
intractable pain of the trunk and/or limbs. 

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7. Product Description 
7.1 General  
The Intellis™ with AdaptiveStim™ Technology neurostimulation system will be used in this study.  
Neurostimulation systems include a neurostimulator, lead(s), extension(s), programmers, and 
accessories. This study will include only Medtronic commercially available products used within their 
intended approved indication. Products will be obtained through normal commercial channels and will 
not be provided as a part of this study. 
 
The implanted components of the Intellis™ with AdaptiveStim™ system include the following: 
• 
Model 97715 Intellis™ with AdaptiveStim™ neurostimulation system 
• 
Model 977D260 Vectris™ 1x8 Compact Trial Screening Lead Kit 
• 
Models 977A260, 977A275, and 977A290 Vectris™ SureScan™ MRI 1x8 Compact Lead Kits 
• 
Models 97791 and 97792 Injex™ Anchor Accessory Kits 
 
The non-implanted components of the Intellis™ with AdaptiveStim™ system include the following: 
• 
Model 97725 Wireless External Neurostimulator 
• 
Model 97745 Patient Controller 
• 
Model 375003 Boot for Wireless External Neurostimulator 
• 
Model 97755 Recharger 
• 
Model 8880T2 Communicator 
• 
Other accessories used (e.g., tunneling tools, needle kits, wrenches, or screws) 
7.2 Manufacturer 
The neurostimulation system is manufactured by Medtronic, Inc. with operational headquarters in 
Minneapolis, Minnesota 55432-5604, USA. 
7.3 Packaging 
The devices that will be used in this study have been approved or cleared by the FDA for spinal cord 
stimulation as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The 
devices specified in Section 7.1 will be shipped in their commercially available form which includes 
packaging and labeling.  
7.4 Intended Population 
In the United States a Medtronic implantable neurostimulation system is indicated for spinal cord 
stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or 
limbs-including unilateral or bilateral pain associated with the following conditions according to product 
labeling: 
• 
Failed Back Syndrome (FBS) or low back syndrome or failed back 
• 
Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated 
disk 
• 
Post Laminectomy pain 

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Multiple low back operations 
• 
Unsuccessful disk surgery 
• 
Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical 
interventions 
• 
Peripheral causalgia 
• 
Epidural fibrosis 
• 
Arachnoiditis or lumbar adhesive arachnoiditis 
• 
Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or Causalgia 
7.5 Product Use 
The Medtronic Intellis™ with AdaptiveStim™ Technology Neurostimulation System and related 
components and accessories are commercially available for SCS in the United States and shall be used in 
accordance with commercial labeling. Exposure to the study product is considered from the time the 
subject is first exposed to the neurostimulation system, at the beginning of the device trial, until the 
product is explanted, or the subject discontinues from the study, if later.  
7.6 Product Training Materials 
Only investigators who are trained and experienced in implanting neurostimulation spinal cord 
stimulation systems will perform the implant procedures required for this clinical study. 
7.7 Product Return 
All products are commercially available, and no products will be provided from Medtronic as a part of 
this study. All explanted devices (devices or leads or activators, etc.) should be returned to Medtronic 
for analysis when permissible by local laws and regulations. If the products are explanted but not 
returned, a justification will be reported on the appropriate case report forms or disposition logs. To 
receive a Returned Product Mailer Kit, please contact your local Medtronic field personnel. 
7.8 Product Accountability 
All products are commercially available, and no products will be provided from Medtronic as a part of 
this study; therefore, no device accountability or traceability is required. 
8. Study Site Requirements 
8.1 Investigator/Investigation Site Selection 
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety and well-being of the subjects 
involved in the clinical investigation. 
The principal investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be experienced in the field of application and training in the use of spinal cord stimulation 

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• 
Be able to demonstrate that the proposed investigational study site: 
 
Has the required number of eligible subjects needed within the recruitment period 
 
Has one or more qualified investigators, a qualified investigational study site team 
and adequate facilities for the foreseen duration of the clinical investigation 
Study site personnel training will be completed and documented prior to participation in this study. 
8.2 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train study site personnel on 
the clinical investigation plan, relevant standards and regulations (as required), informed consent, 
programming, and data collection and reporting tools. If new members join the study site team, they 
will receive training on the applicable study requirements relevant to their role before contributing to 
the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following:  
• 
IRB approval (and voting list, as required by local law) of the current version of the CIP and 
IC.  
• 
Fully executed CTA  
• 
CV/medical license of investigators and key members of the investigation study site team (as 
required).  
• 
Documentation of delegated tasks. 
• 
Documentation of study training.  
In addition, all participating study site staff must be trained on the current version of the CIP as well as 
on the applicable study requirements depending on their role and must be delegated by the principal 
investigator to perform study related activities.   
Medtronic will provide each study site with documentation of study site/investigator readiness; this 
letter must be received prior to performing study related activities. 
8.3 Role of the Sponsor Representatives 
Sponsor representatives who are qualified and trained on the protocol may participate in the conduct of 
the study under the direct supervision of the principal investigator as described below.  The principal 
investigator or other study site personnel designated on the delegation of authority form must collect all 
required data, record the study activities, and be responsive to the subject’s needs during an activity 
performed by a sponsor representative. Sponsor representatives may provide support at the study site 
as required for the study under supervision of the Principal Investigator, including: 
• 
Provide study training relevant and pertinent to the involvement of personnel conducting 
study activities and investigator responsibilities 
• 
Provide technical support at visits under the supervision of a study investigator 
• 
Perform monitoring and auditing activities  
In addition, for this study, sponsor representatives may be authorized by the principal investigator to 
perform the following trial related duties:  

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• 
Support study investigators in performing the study trial/implant procedure 
• 
Support data collection during the trial/implant procedure and device testing 
• 
Support data collection during visits 
• 
Perform device programming, device interrogation, and device download including printing 
or uploading of device information 
• 
Identify location of active lead contacts using images 
• 
Collect stimulation thresholds 
• 
Discuss any issues with programming or subject compliance with the principal investigator 
or other site personnel 
Medtronic personnel may not perform the following: 
• 
Practice medicine, provide medical diagnoses or make decisions related to subject 
treatment/care 
• 
Discuss a subject’s condition or medical treatment with the subject or a member of the 
subject’s family 
• 
Assist the subject by direct physical contact except as required by the specific protocol-
related task to be conducted 
• 
Complete source documents or entry into the electronic medical record 
• 
Enter data on eCRFs, with the exception of Medtronic Use Only fields/forms 
9. Selection of Subjects 
9.1 Study Population 
The intended study population is patients with chronic intractable back and leg pain.  
9.2 Subject Enrollment 
A subject is considered enrolled into the study when the subject and the principal investigator or 
authorized designee, as required, have personally signed and dated the IC. The date the subject signed 
the IC, and data protection authorization if applicable, must be documented in the subject’s medical 
records. Subjects will be screened to ensure they meet all of the inclusion and none of the exclusion 
criteria to be eligible to participate in this study. A subject who does not meet inclusion/exclusion 
criteria or who discontinues prior to implant for any other reason (e.g. fails device trial, cannot be 
implanted due to hardware, etc.) will be considered a screen fail.  Subjects will continue to be followed 
in the study once device activation after implant has been completed, except in the case of early 
withdrawal.  
9.3 Inclusion Criteria 
To be included in this study, a patient must meet the following inclusion criteria:  
1. 18 years of age or older 
2. Willing and able to provide signed and dated informed consent 

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3. Capable of comprehending and consenting in English 
4. Candidate per labeling for an SCS system (trial and implant) as an aid in the management of 
chronic, intractable pain of the trunk and/or limbs 
5. Has moderate to severe back and leg pain, as determined by the investigator, or designee 
6. Baseline VAS is ≥6 for overall pain 
7. Baseline VAS is ≥6 for back or leg pain 
8. ODI score of 21 to 80 out of 100 
9. On stable (no change in dose, route, or frequency) pain medications (prescribed and over-the-
counter) being used specifically for back and leg pain, as determined by the investigator or 
designee, for at least 28 days prior to enrolling in the study 
10. Willing and able to comply with all study procedures and visits 
11. Willing and able to not increase their pain medications (prescribed and over-the-counter) being 
used specifically for back and leg pain through the 3-month visit 
12. Able to differentiate between pain associated with the indication for SCS implant and other 
types of pain, as determined by the investigator, or designee 
Additional inclusion criteria, to be evaluated at device trial/implant: 
1. Final lead placements span 
 T8 to 
 T10 after patient flexion at Device Trial 
2. The subject reports ≥ 50% improvement in overall pain relief at the Device Trial End Visit 
3. Final lead placements span 
 T8 to 
 T10 at Device Implant 
9.4 Exclusion Criteria 
To be included in this study, a patient must not meet any of the following exclusion criteria:  
1. Previously trialed or implanted with spinal cord stimulator, peripheral nerve stimulator, or an 
implantable intrathecal drug delivery system 
2. Expected to be inaccessible for follow-up 
3. Current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic 
neurogenic claudication as determined by the investigator, or designee 
4. Currently enrolled or planning to enroll in an interventional clinical study that could potentially 
confound the study results (co-enrollment in an interventional study is only allowed when 
documented pre-approval is obtained from the Medtronic study manager, or designee) 
5. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable 
form of birth control during the study 
6. Has untreated major psychiatric comorbidity, as determined by the investigator, or designee 
7. Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as 
determined by the investigator, or designee 
8. Unable to achieve supine or prone position 
9. If subject is classified as vulnerable or requires a legally authorized representative (LAR) 

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10. Study Procedures 
10.1 Schedule of Events 
Figure 10-1 is a flow diagram of how subjects will complete the study. Subjects will be required to come 
into the clinic for up to 10 study visits: 
• 
Enrollment/Baseline Visit 
• 
Device Trial Start Visit  
• 
Device Mid-Trial Visit (if necessary) 
• 
Device Trial End Visit 
• 
Device Implant Visit 
• 
Device Activation Visit (Day 0) 
• 
1-Month Visit 
• 
3-Month Visit 
• 
6-Month Visit 
• 
12-Month/Final Study Visit 
 

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Figure 10-1: Study Visit Diagram 
 
 
10.2 Data Collection 
Study procedures, tasks and data collection requirements are summarized in Table 10-1 below. 

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considered an increase in pain medications if the medication is ceased prior to the date of the Device 
Activation Visit. 
Subjects that have previously been trialed or implanted with spinal cord stimulator, peripheral nerve 
stimulator, or an implantable intrathecal drug delivery system will not be eligible to participate in the 
study. 
10.6 Subject Consent 
Informed consent is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular study after information has been given and explained to the 
subject on all aspects of the  study that are relevant to the subject’s decision to participate. This process 
includes obtaining an IC form and a/an Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language as required by law that has been approved 
by the study site’s IRB and signed and dated by the subject. A subject may only consent after 
information has been given and explained to the subject on all aspects of the clinical investigation that 
are relevant to the subject’s decision to participate.  
Prior to enrolling subjects, the IC site and the Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language as required by law must be approved by the 
IRB.  The document(s) must be controlled (i.e. versioned and/or dated) to ensure it is clear which 
version(s) were approved by the IRB.  Any adaptation of the sample IC must be reviewed and approved 
by Medtronic and the IRB reviewing the application prior to enrolling subjects.  
The investigator must notify the subject of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the subject, 
as this could impact a subject’s willingness to participate in the study. If relevant, consent may be 
requested from subjects to confirm their continued participation. 
Prior to initiation of any study-specific procedures, IC must be obtained from the subject. Likewise, 
privacy or health information protection regulation may require subjects to sign additional forms to 
authorize study sites to submit subject information to the study sponsor. The IC process must be 
conducted by the principal investigator or an authorized designee, and the IC Form and Authorization to 
Use and Disclose Personal Health Information/Research Authorization/other privacy language as 
required by law must be given to the subject in a language he/she is able to read and understand. Only 
subjects capable of reading and understanding English are eligible to participate in this study. Signing 
and dating of the ICF or HIPAA authorization or other data protection form by a legally authorized 
representative will not be permitted for this study. The process of IC must be conducted without using 
coercion or undue improper influence on or inducement of the subject to participate by the investigator 
or other study site personnel. The IC process shall not waive or appear to waive subject’s legal right. The 
language used shall be as non-technical as possible and must be understandable to the subject and the 
impartial witness, where applicable.  
The subject must have ample time and opportunity to read and understand the IC form, to inquire about 
details of the study, and to decide whether or not to participate in the study. All questions about the 
study should be answered to the satisfaction of the subject. 
When the subject decides to participate in the study, the IC must be signed and personally dated by the 
subject and investigator or authorized designee, as required by the IC, and ensured by the principal 

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investigator or his/her authorized designee. Subjects must be able to personally sign and date the 
consent form to participate in this study. 
A copy of the IC and the Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language, signed and dated as required by law, must be provided to the 
subject.  
If the IC is obtained the same day the subject begins participating in study-related procedures, it must 
be documented in the subject’s case history that consent was obtained prior to participation in any 
study-related procedures. It is best practice for the IC process to be documented in the subject’s case 
history, regardless of circumstance. 
The original of the signed IC must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  
The IC and Authorization to Use and Disclose Personal Health Information/Research Authorization/other 
privacy language as required by law must be available for monitoring and auditing. Any Medtronic Field 
personnel who support the study visits must be able to review the subject’s signed and dated IC and 
verify its completeness prior to proceeding with visit support. In the event the Medtronic Field 
personnel identify IC as being incomplete, study visits/procedures will not be allowed to occur until the 
consent of the subject can be adequately and appropriately obtained.  
10.7 Enrollment/Baseline 
A subject is considered enrolled when the consent process has been finalized. The date the subject 
signed the IC and Data Protection Authorization, as required by law, must be documented in the 
subject’s medical records. At the Baseline visit, subjects will be consented prior to any study-related 
procedures or testing being conducted. Subjects in compliance with inclusion/exclusion criteria will be 
eligible to participate. A VAS score for overall (back and leg), back, and leg pain will be collected. 
Subjects that do not have a VAS ≥ 6 cm for overall pain and a VAS ≥ 6 cm for either back or leg pain will 
be exited from the study.
 
. Subjects that meet eligibility criteria will proceed with the remaining data 
collection for the baseline visit and will be scheduled for a device trial. The baseline visit can be a stand-
alone visit or can be performed on the same day as the Device Trial Start Visit.  
The following information will be collected at the baseline visit: 
• 
Informed Consent 
• 
Inclusion/Exclusion Criteria 
• 
Demographics 
• 
Medical/surgical history 
• 
VAS 
 
 
 
 
 
 
 
 
• 
Pain Medications 

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10.8 Device Trial 
The Device Trial Start Visit must occur within 14 days of the Baseline Visit.  Subjects will have up to 3 
Device Trial Visits: 
• 
Device Trial Start Visit 
• 
Device Mid-Trial Visit (if necessary) 
• 
Device Trial End Visit 
10.8.1 
Device Trial Start (≤ 20 days post-Baseline) 
All eligible subjects will undergo an SCS Device Trial per labeling that includes intraoperative testing. 
Subjects will be implanted with two Medtronic compact percutaneous leads as a part of the device trial 
procedure. No devices will be provided by the sponsor as a part of this study. A flexion maneuver will be 
performed. If subjects have leads spanning the 
 T8 to 
 T10 vertebral levels after trial lead implant 
and flexion maneuver, they will continue in the study and DTM-LE stimulation will be programmed for 
pain relief and comfort. The most recent fluoroscopy/x-ray will be used to confirm lead location. DTM-LE 
SCS will deliver different, simultaneously running signals within the range of FDA-approved device 
capabilities to 
 different locations between 
 T8 and 
 T10 vertebral levels and will be 
programmed within the following limits: 
 
 
 
 
 
 
 
 
 
 
 
 
 During this visit, subjects will be 
provided with a patient programmer and wireless external neurostimulator (WENS) and educated on 
their use. Subjects will be informed how they can turn their device off, if needed. 
The following information will be collected at the Device Trial Start Visit: 
• 
Device Information 
• 
Programming parameters/device interrogation report(s) with initial and final settings  
• 
Imaging (post flexion maneuver) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.8.2 
Device Mid-Trial (If necessary) 
Subjects will be called during the device trial by a sponsor representative (e.g., field clinical engineer) to 
assess effectiveness of stimulation parameters and facilitate re-programming, as needed.  Subjects may 
come in for a study visit during the trial, if necessary, for issues (such as inadequate pain relief that 

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requires in-clinic re-programming/device interrogation) that cannot be addressed over the phone.  
Imaging may be performed to assess for lead migration if deemed necessary by the investigator. 
The following information will be collected at the Device Mid-Trial Visit, if conducted: 
• 
Programming parameters/device interrogation report(s) with initial and finial settings  
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.8.3 
Device Trial End 
Subjects will be trialed per standard of care and within device labeling limits while enrolled into the 
study. Subjects will come in for the Device Trial End Visit within 7 days of the device trial start. At the 
Device Trial End Visit, if a subject has ≥ 50% improvement in overall pain with DTM-LE SCS programming, 
they will have their trial leads explanted and will proceed to implant. If a subject does not have ≥ 50% 
overall pain relief with DTM-LE SCS programming, they will be treated per standard of care and exited 
from the study. The outcome of the trial for those subjects that did not have a successful DTM-LE SCS 
trial will be recorded (success or failure).  Trial lead explant must occur within 10 days of trial lead 
implant.  Imaging may be performed to assess for lead migration if deemed necessary by the 
investigator. 
The following information will be collected at the Device Trial End Visit: 
• 
Percent Improvement in Overall Pain 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.9 Device Implant (≤ 35 days post Device Trial End) 
Subjects who report a positive device trial (≥ 50% improvement in overall pain) with DTM-LE SCS 
parameters and who meet eligibility criteria will be implanted with a Model 97715 Intellis™ with 
AdaptiveStim™ neurostimulation system including two Model 977A260/75/90 Vectris™ leads per 
standard of care and within device labeling. No products will be provided from Medtronic as a part of 
this study.  Prior to system implant, eligibility criteria must be re-confirmed by the investigator and 
documented in source records. Subjects who have leads spanning the 
 T8 to 
 T10 vertebral levels 
will continue in the study. Once in the recovery room, the device will be interrogated to measure 
electrode impedances and make sure that the device programming is ”OFF”. Device interrogation 
report(s) will be uploaded via CDU. 
The following information will be collected at the Device Implant Visit: 
• 
Device Information 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging  

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• 
Changes to pain medications 
• 
AEs/DDs 
10.10 
Device Activation (Day 0; 9-16 days after implant) 
The Device Activation visit will take place 9-16 days after implant, pending wound healing.  If wound has 
not healed, the Device Activation Visit will be rescheduled.  Device Activation is considered Day 0 for the 
purpose of calculating the post implant visits and telephone calls.  Imaging may be performed to assess 
for lead migration if deemed necessary by the investigator. The subject’s most recent imaging should be 
referenced for programming. The stimulator will be turned “ON” at this visit and the subject will be 
programmed within the following limits: 
 
 
 
 
 
 
 
 
 
 
During this visit, subjects will be educated on the use of their patient programmer/recharger. Subjects 
will be informed how they can turn their device off, if needed. Device interrogation report(s) with initial 
and final programmed settings will be uploaded via CDU.  
The following information will be collected at the Device Activation Visit: 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.11 
Post Implant Telephone Calls 
Subjects will be called by delegated study site personnel post-device activation to assess pain relief 
status and confirm that their stimulator is on.  Subjects will also be assessed for AEs (new or existing) 
and asked about any pain medication changes.  Phone calls will be performed weekly up to the 3-Month 
Visit and then monthly following the 3-Month Visit. If an in-clinic visit falls on the week or month of a 
scheduled telephone call, the call will not be performed. If the subject reports inadequate pain relief, 
the subject will be called by a sponsor representative (e.g., field clinical engineer) to assess if re-
programming is required.  The subject may come in for an unscheduled visit, if necessary, for issues that 
cannot be addressed over the phone.   
The following information will be collected during phone calls: 
• 
Pain relief/programming feedback 
• 
Changes to pain Medications 
• 
AEs/DDs 

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10.12 
Post-Implant Scheduled Visits 
10.12.1 
1-Month Visit 
The 1-Month visit will occur 30 days ± 10 days after device activation (Day 0). Following the completion 
of all subject assessments required for this visit (see below), AdaptiveStim™ as well as the Position Diary 
will be turned ON and the device will be oriented. AdaptiveStim™ will then be turned OFF  and 
stimulation threshold testing will be performed in the upright and supine positions for all programmed 
groups. AdaptiveStim™ may be turned back on, if needed, on an individual basis with sponsor approval. 
Before configuring AdaptiveStim™ Technology, it is recommended to allow a 4-week healing period after 
implanting the neurostimulator to allow time for the implanted components to stabilize. If there is not a 
≥ 50% decrease in the VAS for overall pain collected at the visit compared to the Baseline VAS for overall 
pain, the subject may be re-programmed within the following limits: 
 
 
 
 
 
 
 
 
 
 
Device interrogation report(s) with initial and final programmed settings will be uploaded via CDU. 
Imaging may be performed to assess for lead migration if deemed necessary by the investigator. 
The following information will be collected during the 1-Month Follow-up visit: 
• 
VAS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.12.2 
3-Month Visit 
The 3-Month visit will occur 90 days ± 15 days after device activation (Day 0). If there is not a ≥ 50% 
decrease in the VAS for overall pain collected at the visit compared to the Baseline VAS for overall pain, 
the subject may be re-programmed. If re-programming occurs, device interrogation report(s) with initial 

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and final programmed settings will be uploaded via CDU. Imaging may be performed to assess for lead 
migration if deemed necessary by the investigator. 
The following information will be collected during the 3-Month Follow-up visit: 
• 
VAS 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.12.3 
6-Month Visit  
The 6-Month visit will occur 180 days ± 30 days after device activation (Day 0). If there is not a ≥ 50% 
decrease in the VAS for overall pain collected at the visit compared to the Baseline VAS for overall pain, 
the subject may be re-programmed. If re-programming occurs, device interrogation report(s) with initial 
and final programmed settings will be uploaded via CDU. Imaging may be performed to assess for lead 
migration if deemed necessary by the investigator. 
The following information will be collected during the 6-Month Follow-up visit: 
• 
VAS 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.12.4 
12-Month/Final Study Visit 
The 12-Month/Final Study visit will occur 360 days ± 30 days after device activation (Day 0). At the 
completion of this visit subjects will be programmed per standard of care and exited from the study. 
Imaging may be performed to assess for lead migration if deemed necessary by the investigator.  
The following information will be collected during the 12-Month Follow-up visit: 
• 
VAS 
 
 
 
 
 
 

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• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.13 
Unscheduled Visits 
Unscheduled visits may occur if programming changes are required to correct programming errors, to 
reprogram to optimize pain control, or as needed for an AE or DD.  Whenever feasible, subjects should 
have their devices interrogated. Imaging may be performed to assess for lead migration if deemed 
necessary by the investigator and subjects may be re-programmed, if necessary. 
The following information may be collected at unscheduled follow-up visits: 
• 
VAS 
• 
Reason for the visit 
• 
Programming parameters/device interrogation report(s) with initial and finial settings 
• 
Imaging (if performed) 
• 
Changes to pain medications 
• 
AEs/DDs 
10.14 
Device Interrogation  
For visits occurring at the study site, device interrogation report(s) with initial and final interrogation 
settings as well as electrode impedance measurements must be obtained and uploaded via CDU when 
programming occurs, if applicable.  Source for the interrogation reports should be kept at the study site. 
It is recommended that data are not cleared during any interrogation. 
10.15 
Imaging 
Fluoroscopy or x-ray images will be obtained at Device Trial and Permanent Implant.  Images may also 
be obtained at any other time the investigator feels is necessary to perform images per standard of care. 
Any images collected for the study will be annotated with a vertebral marker and the distal electrode on 
each lead will be annotated to reflect which one is electrode 0 and which is electrode 8. 
10.16 
System Modification 
A system modification will be reported in the event the initially implanted device requires invasive 
modification. System modifications (e.g. lead or device revision, replacement, or explant) may occur due 
to ineffective or loss of therapy, adverse event, or device deficiency. In the event of a system 
modification, the follow-up schedule for the subject will remain unchanged. If a system modification 
occurs, contact a member of the Medtronic study team as the decision to allow the subject to continue 
with the study will be handled on a case-by-case basis.  

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The following information will be collected for a system modification: 
• 
Device interrogation report(s) with initial and final programmed settings from the old and 
new implantable neurostimulator (INS) uploaded via CDU, if replaced and subject remains in 
the study 
• 
If any portion of the implanted system is replaced, record all changes in source 
documentation and device identification CRF (e.g. new lead model/serial number) 
• 
AEs/DDs 
All explanted product should be returned to Medtronic for analysis when permissible by local laws and 
regulations. See Section 7.7 for product return details. 
10.17 
Assessment of Efficacy 
Subject assessments will be performed by appropriately trained, qualified and delegated site personnel 
according to the usual practices of the site.   
10.17.1 
Visual Analog Scale (VAS) 
Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning “no pain” and 10 cm meaning “worst 
pain imaginable”. Overall pain is defined as a combination of back and leg pain, but not pain from other 
body parts. Subjects will be asked to report their average pain intensity (overall, back, and leg) that is 
related to their SCS device treatment “in the last 24 hours” by marking a line perpendicular to the VAS 
line at the point that represents their pain intensity.  Site personnel will determine the score by 
measuring the distance (cm) on the 10-cm line between the left, “no pain” anchor and where the 
subject’s mark meets the line.  The total length of the line will be measured (to ensure that it is 10 cm) 
and the distance from the “no pain” mark to the subject’s mark divided by the total distance of the line 
will be recorded. The scored VAS ranges from 0 – 10. 
The VAS will be collected during the Enrollment/Baseline, 1-, 3-, 6-, and 12-Month visits. The VAS will 
also be collected at any unscheduled visits, as applicable. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
   

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10.17.8 
Pain Medications 
Only medications used specifically for the treatment of back and/or leg pain will be collected during the 
study. Pain medications will be collected at baseline and any changes to pain medications will be 
collected throughout the study. 

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10.17.11 
Programming Parameters 
Programming parameters will be collected during the Device Trial, Device Implant, Device Activation, 1-, 
3-, 6-, and 12-Month visits.  Programming parameters will also be collected at unscheduled visits, as 
applicable.  Imaging collected as a part of standard of care will also be collected during the study to be 
used in reference to programming. 
10.18 
Assessment of Safety 
This study will collect and characterize all device-related, therapy-related, and procedure-related 
adverse events and device deficiencies from the time the subject is enrolled until study exit. See Section 
12 for further information on the collection of AEs and safety. 
10.19 
Recording Data 
Data entered must be traceable to source documents. Source documentation is defined as the first time 
data appear, and may include original documents, data, and records (e.g., hospital records, clinical and 
office charts, procedure reports, laboratory notes, memoranda, subjects’ assessments or evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate copies, X-rays, and subject files). 
In general, eCRFs (or paper copies) may not serve as source documents. Source documentation for data 
elements not routinely captured in medical records may vary from study site to study site; the study site 
may use source document worksheets if identified as source documents. 
The investigator must ensure the availability of source documents from which the information on the 
eCRFs was derived. The type and location of source documents should be documented. Where printouts 
of electronic medical records, are provided as source documents, or where copies of source documents 
are retained as source documents, those should be certified. Certification must contain (1) the signature 
of the individual making the copy, (2) the date the copy was made and (3) a statement attesting to the 
accuracy and completeness of the copy.  
The source documents must be made available for monitoring or auditing by Medtronic’s representative 
or representatives of the competent authorities and other applicable regulatory agencies. 
10.19.1 
Case Report Form Data 
This study will use a remote data capture (RDC) system to collect study required Case Report Form (CRF) 
information. Electronic CRFs (eCRFs) will be provided by the sponsor; required data will be taken from 
source documents and directly entered into the study database via the eCRFs by the appropriately 

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delegated site personnel, in accordance with applicable regulations.
 
 Data from the subject assessments will be entered into the database by delegated site personnel. 
Representatives from the clinical site may not make changes to the diaries except for administrative 
entries. The principal investigator, or appropriately delegated personnel, are responsible for entering 
data on the eCRFs. The principal investigator, or appropriately delegated personnel, is required to 
approve all data on eCRFs via electronic signature. 
10.19.2 
Programming Parameter Data 
Through device interrogations with the Model A710 Intellis Clinician Programmer Application/8880T2 
Communicator, programming and device data (eg, session data files) will be collected from the 
neurostimulator. These data will be electronically transferred as a PDF file to a computer at the study 
site using Clinical Data Upload (CDU). Those PDF files can then be stored as a source document at the 
site and be uploaded into the Neuro Programmer Upload (NPU) application. The NPU application is 
designed to capture programming and device data (eg, “session data reports”) and store them within a 
Medtronic database for analysis and reporting. If programming and device data are not able to be 
uploaded into NPU, these data may be securely transferred to Medtronic. 
10.19.3 
Image Data 
Images collected during the study will be annotated with a vertebral marker and the highest electrode 
on each lead will be annotated to reflect which one is electrode 0 and which is electrode 8. Site 
personnel will redact, at a minimum, the subject’s name and label each image with the Subject’s ID prior 
to sending them to Medtronic via upload to a secure file sharing application. Medtronic will keep all 
copies of the images that they receive in a secure location and may use them for other business 
purposes outside of this study. 
10.20 
Deviation Handling 
A study deviation is defined as an instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the CIP, IRB, or CTA. The investigator is not allowed to deviate from the CIP, except 
under emergency circumstances to protect the rights, safety and well-being of human subjects. Prior 
approval by Medtronic is expected in situations where the investigator anticipates, contemplates, or 
makes a conscious decision to deviate. Prior approval is not required when a deviation is necessary to 
protect the safety, rights or well-being of a subject in an emergency or in unforeseen situations beyond 
the investigator’s control (e.g. subject failure to attend scheduled follow-up visits, inadvertent loss of 
data due to computer malfunction, inability to perform required procedures due to subject illness). For 
medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis). However, 
prior approval from Medtronic is required for such situations.  

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All study deviations must be reported on the CRF regardless of whether medically justifiable, pre-
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
Multiple deviations of the same type at the same visit may be reported on one case report form. 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life 
or physical well-being of a subject in an emergency, the deviation must be reported to the IRB as well as 
Medtronic within five (5) working days. Reporting of all other study deviations should comply with IRB 
policies, RA requirements, and/or local laws and must be reported to Medtronic as soon as possible 
upon the study site becoming aware of the deviation.  
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, 
terminate the investigation). Repetitive or serious investigator compliance issues may result in initiation 
of a corrective action plan with the investigator and study site, and in some cases, may necessitate 
suspending enrollment until the problem is resolved or ultimately terminating the investigator's 
participation in the study. Medtronic will provide study site-specific reports to investigators summarizing 
information on deviations that occurred at the investigational study site on a periodic basis.  
Examples of study deviations include but are not limited to: 
• 
Failure to obtain proper IC 
• 
Failure to collect required study data (e.g. required subject assessments) 
• 
Inclusion/exclusion criteria not met 
• 
Missing required device interrogation files 
• 
Visits outside of window 
10.21 
Subject Exit, Withdrawal or Discontinuation 
A subject has the right to withdraw from the study at any time and for any reason without prejudice to 
his/her future medical care by the principal investigator or institution.  Subjects will be provided 
standard medical care by their physician after their study participation ends.  
If a subject is withdrawn from the study, the reason for withdrawal shall be recorded on a study exit 
eCRF and in the subject’s medical record.  Subjects are urged to remain in the study as long as possible 
but may be exited from the study for any of the following situations: 
• 
Eligibility criteria not met 
• 
Pregnancy 
• 
Failure to follow study requirements 
• 
Subject death 
• 
Subject lost to follow-up (LTFU)  
• 
Subject chooses to withdraw (e.g., consent withdrawal, relocation to another geographic 
location)  
• 
Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion 
criteria not met, failure of subject to maintain adequate study compliance)  
• 
Adverse events  
• 
Normal study completion 

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A study exit eCRF, including reason for exit, is required for all subjects and will be completed for any 
enrolled subject who permanently discontinues from the study or completes the protocol-required 
study follow-up and has completed the study. Prior to exiting a subject from the study, it is 
recommended to follow the subject until all ongoing device, therapy, and/or procedure related AEs are 
resolved or unresolved with no further actions planned.  Following exit, subjects will continue to receive 
standard medical care.  Upon exiting from the study, no further study data will be collected, or study 
visits will occur for the subject. All data available through the time of the subject’s exit will be used for 
analysis. If discontinuation is because of safety or lack of effectiveness, the subject may be asked to be 
followed for collecting safety data outside the clinical investigation. 
10.21.1 
Study Completed  
At the completion of the 12-month follow-up/final study visit, subjects will be exited from the study, 
both a 12-month follow-up/final study visit CRF and a Study Exit CRF need to be completed. 
10.21.2 
Lost to Follow-up 
A subject is considered to be lost to follow-up if at least two attempts to contact the subject are 
unsuccessful. The method of attempt (e.g., one letter and one phone record, or two letters) must be 
documented in the subject’s medical record. In addition, regulations set forth by the governing IRB must 
be followed.  
10.21.3 
Conditional Disengagement 
After a subject is enrolled every effort should be made to keep the subject in the study. However, it is 
recognized that there are circumstances where limited data may be collected, or study exit will need to 
occur. In these cases, we will consider either modified data collection requirements where subjects may 
conditionally disengage in study procedures but data from the subject can still be collected because the 
subject has not revoked consent, or exit when study participation is completely ended.  
Subjects may be conditionally disengaged from study procedures for any of the following reasons: 
• 
Subject chooses to disengage (e.g., follow-up schedule cannot be adhered to, study 
burden too large, relocation to another geographic location but telephone follow-up still 
acceptable)  
• 
Investigator deems conditional disengagement necessary (e.g. medically justified)  
If the subject wishes to disengage from the study, or the investigator deems it necessary, the study site 
is required to document the reason. Prior approval from the study team is required and data collection 
requirements no longer apply, but study sites are encouraged to collect as much data as possible on the 
regular CRFs. 
11. Risks and Benefits 
11.1 Potential Risks  
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post-market surveillance. 
This is a post-market study and subjects will be treated in accordance with the labeled instructions for 

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use and indications for Medtronic’s SCS therapy. There are foreseeable risks that exist for all SCS 
patients regardless of whether they are in the study. Furthermore, there are additional risks associated 
with subjects taking part in this study which are stated in Section 11.1.1.5 and there may be additional 
risks related to this study, other than the ones described below, that are not yet known.    
11.1.1 
Foreseeable Risks 
11.1.1.1 
Risks of Surgery 
Implanting a neurostimulation system has risks similar to spinal procedures, including spinal fluid leak 
(spinal fluid collection under the skin), headaches, swelling, bruising, bleeding, infection, or paralysis.  
Subjects on anticoagulation therapy may be at higher risk for problems after surgery such as hematomas 
that could result in paralysis. 
11.1.1.2 
Spinal Cord Stimulation Adverse Events Summary 
The implantation of a spinal cord stimulation system involves risks that are similar to other spinal 
procedures. In addition to those risks associated with surgery, the following adverse events may occur 
with implantation or use of a neurostimulation system:  
• Allergic or immune system response to the implanted materials  
• Infection  
• Lead, extension, or neurostimulator erosion through the skin or migration  
• Leakage of cerebrospinal fluid  
• Loss of pain relief may return patients to their underlying pain condition  
• Patients on anticoagulation therapies may be at greater risk for postoperative complications such 
as hematomas that can result in paralysis  
• Persistent pain at the neurostimulator site  
• Placement of the epidural lead-extension is a surgical procedure that may expose patients to risks 
of epidural hemorrhage, hematoma, or paralysis  
• Radicular chest wall stimulation  
• Seroma or hematoma at the neurostimulator site  
• Change in stimulation, possibly related to cellular changes around the electrode(s), shifts in 
electrode position, loose electrical connections, lead or extension fractures, which has been 
described by some patients as uncomfortable stimulation (jolting or shocking sensation).  
• Formation of reactive tissue around the lead in the epidural space can result in delayed spinal cord 
compression and paralysis, requiring surgical intervention. Time to onset can range from weeks 
to many years after implant.  
• Stimulation-dependent gastrointestinal symptoms such as diarrhea, incontinence, or constipation  
• Stimulation-dependent bladder symptoms such as urinary retention, incontinence, or frequency  
 
The safety and effectiveness of this therapy has not been established for pregnancy, unborn fetus, or 
delivery. The study procedures may involve unknown risks for female subjects, their embryo or fetus 
(unborn child), or delivery if they become pregnant. For this reason, pregnant females have been 

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excluded from participating in this study. Female subjects must agree to not become pregnant during 
the study by using a medically acceptable method of birth control; an identified pregnancy will result in 
immediate study withdrawal. 
11.1.1.3 
System Revision Risk 
The Intellis neurostimulators will provide at least 9 years of operation before replacement is 
recommended. It is possible that the system will need to be revised (explanted, replaced, or 
repositioned) earlier than 9 years. Possible reasons for revision/explant may include infection, 
malfunction, and migration of the system components. The risks associated with system revision are 
equivalent to the commercially available systems. 
11.1.1.4 
Risks Associated with the Recharging System 
The recharger, antenna, and belt are not sterile, and contact with the wound could cause an infection. 
The recharger is not intended to be used on an unhealed wound. Use of rechargeable neurostimulation 
systems may be associated with adverse events including heating sensation, discomfort, blistering not 
caused by heating, skin irritation, or redness near the implanted neurostimulator during or after 
recharging. Subjects should check for skin irritation or redness near the neurostimulator during 
recharging.  
11.1.1.5 
Study-Specific Risks 
Parameters used during the study may not be effective, which could result in an increased level of pain.  
Although secure electronic systems will be used, data will be anonymized, and other measures will be 
taken in this study to protect subject privacy there is not a guarantee of absolute confidentially and 
privacy; therefore, there is a slight risk of a loss of subject privacy in case of a data breach involving a 
subject's protected health information. 
11.2 Risk Minimization 
The potential risks associated with the study were assessed, identified, and have been mitigated as far 
as possible. Any potential risks associated with this study are further minimized by selecting qualified 
investigators with proper SCS therapy and device implantation experience and training study personnel 
on the CIP. Instructions will be given to the study participants to ensure they can properly use the 
patient programmer/recharger system and at any time during the study, subjects will be able to turn 
their device “OFF”. Furthermore, a subject has the right to withdraw from the study at any time and for 
any reason (e.g., due to insufficient pain relief). Labeling that contains precautions, warnings, and 
contraindications, as well as instructions on the use of the devices are available to investigators who 
may provide this information to subjects.  
Further mitigations reside in careful construction of the study. This includes selecting an appropriate 
patient population via inclusion/exclusion screening and closely monitoring subject progress and events 
reported for the study. Data will be anonymized, and secure electronic systems will be used for data 
transfer. In addition, investigators will be actively involved in the implantation and follow-up of the 
subjects in the study.  

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11.3 Potential Benefits 
There may be no direct medical benefit to subjects participating in the study. During the study, subjects 
will have increased interaction with physicians or medical staff compared to routine clinical care, which 
may provide some indirect health benefits. Spinal cord stimulation and the settings used during this 
study may reduce pain intensity, return the patient to a more fully functional status, and/or improve 
quality of life. These benefits cannot be guaranteed due to the investigational nature of this study.  
The primary anticipated benefit of this study is to help Medtronic with the understanding of SCS therapy 
and assist with the design of future studies and product improvements. The information gathered from 
this study could also help clinicians optimize therapy for their patients.  
11.4 Risk-Benefit Rationale 
Subjects participating in this study will be exposed to risks from commercial SCS therapy that have been 
deemed, through existing pre-market application approval, to be outweighed by the benefits of treating 
chronic, intractable pain within approved indications. Additional risks that exist due to participation in 
the study, including reduced efficacy and uncomfortable stimulation, are low severity, have been 
minimized by mitigations within the study design, and will be properly communicated to potential 
subjects. Based on the risk acceptance criteria for the DTM-LE SCS Study laid out in the Study Risk 
Management Plan, the study-specific residual risk is determined to be acceptable given the expected 
benefits of furthering the understanding of SCS therapy to inform future studies and product 
improvements outweigh these additional risks and support the conduct of this study. 
12. Adverse Events and Device Deficiencies 
12.1 Adverse Events 
AE definitions are provided in  Table 12-1. All device-related, therapy-related, and procedure-related 
adverse event information will be collected throughout the study duration, starting at the time of 
signing the IC. Each event will be classified according to 5 different levels of causality using the following 
terms: 
• 
Not related 
• 
Unlikely 
• 
Possible 
• 
Probable 
• 
Causal 
Only events that are classified as possible, probable or causal are considered to be related.   
Reporting of these events to Medtronic will occur on an AE Form. Each event must be reported 
separately. Documented pre-existing conditions are not considered AEs unless the nature or severity of 
the condition has worsened and meets reporting criteria. Unavoidable Adverse Events (UAE), listed in 
Table 12-1, need not be reported unless the adverse event worsens or is present outside the stated 
timeframe post-implant.  

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Possible 
The relationship with the use of the investigational device is weak but 
cannot be ruled out completely. Alternative causes are also possible (e.g. 
an underlying or concurrent illness/ clinical condition or/and an effect of 
another device, drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as 
possible. 
Probable 
The relationship with the use of the investigational device seems relevant 
and/or the event cannot reasonably explained by another cause, but 
additional information may be obtained. 
Casual Relationship 
The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
− 
the event is a known side effect of the product category the 
device belongs to or of similar devices and procedures; 
− 
the event has a temporal relationship with investigational device 
use/application or procedures; 
− 
the event involves a body-site or organ that 
− 
the investigational device or procedures are applied to; 
− 
the investigational device or procedures have an effect on; 
− 
the serious event follows a known response pattern to the 
medical device (if the response pattern is previously known); 
− 
the discontinuation of medical device application (or reduction of 
the level of activation/exposure) and reintroduction of its use (or 
increase of the level of activation/exposure), impact on the 
serious event (when clinically feasible); 
− 
other possible causes (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or 
treatment) have been adequately ruled out; 
− 
harm to the subject is due to error in use; 
− 
the event depends on a false result given by the investigational 
device used for diagnosis1, when applicable; 
− 
In order to establish the relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the serious event. 
 
1 If an investigational device gives an incorrect diagnosis, the patient 
might, for example, receive an unnecessary treatment and incur all the 
risks that accompany that treatment, or might be incorrectly diagnosed 
with a serious disease. In other cases, the patient might not receive an 
effective treatment (thereby missing out on the benefits that treatment 
would confer), or might not be diagnosed with the correct disease or 
condition. 

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product reporting systems may be used to gather additional information about the returned 
device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic clinical study team. When a death occurs in a hospital, a copy of the death summary report 
and all relevant hospital records, if available should be sent to the Medtronic clinical study team. If an 
autopsy is conducted, a copy of the autopsy report should also be sent to the Medtronic clinical study 
team if available and allowed by state/local law. When the death occurs at a remote study site, it is the 
investigative study site’s responsibility to attempt retrieval of information about the death. Additionally, 
device disposition information should be updated.  
In summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Relatedness to system and/or procedure 
• 
Device interrogation information/reports and Save-to-Media information/reports (if 
available) 
• 
Device disposition information 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 
12.7 Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable and AEs related to any market-
released device during the study must be reported. The reporting of product complaints is not part of 
the study and should be done in addition to the AE reporting requirements.  Refer to local regulations 
for reporting requirements.  
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that 
has been placed on the market. 
• 
Abuse: Abnormal use (definition acc. #4.1 of Meddev 2.12-1  
• 
Misuse: Use error (definition acc. #4.20 of Meddev 2.12-1) 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse 
of the product. Reporting must be done immediately and via the regular channels for market-released 
products. The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures. Medtronic will notify the RAs (e.g. CA) as applicable for the following 
incidents immediately upon learning of them and is not limited to AEs and DDs only: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, 
as well as any inadequacy in the labeling or instructions for use which led or might have 

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led to the death or serious deterioration in the state of health of a patient, user, or 
other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by 
the manufacturer. 
• 
Any serious deterioration in the state of health, including: 
 
Life-threatening illness or injury 
 
Permanent impairment of a body function or permanent damage to a body 
structure 
 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
13. Data Review Committees 
This study will not use a Clinical Events Committee (CEC), Adverse Events Advisory Committee (AEAC), or 
an independent Data Monitoring Committee (DMC). Instead, regular meetings will be held by sponsor 
personnel, including the Medical Advisor, to review adverse events and device deficiencies, identify 
potential trends in safety data during the clinical study, and ensure consistent reporting.  
14. Statistical Design and Methods 
This section presents statistical considerations for the study design and provides a high-level description 
of planned analysis and reporting. More details will be given in a separate SAP that will be approved 
before data freeze or lock for analysis. Any deviation to the pre-specified statistical analyses will be 
noted in the study report.  
14.1 General Aspects of Analysis 
Data analysis will be performed by Medtronic-employed statisticians or designees. A validated statistical 
software package (e.g., SAS version 9.4 or higher) will be used to analyze the study results. 
General descriptive statistics for categorical and continuous variables will be used: categorical variables 
will be summarized as counts and percentages; continuous variables will be presented using mean, 
standard deviation, median, quartiles and range as applicable. 
 
 
 
  
  
 
  
 
 

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14.1.2 
Handling Missing Data 
Missing data are a potential source of bias when analyzing study data. A rigorous study design and 
execution will help prevent the incidence of missing data from occurring.  
The primary analysis of the primary and secondary objectives will include subjects who follow DTM-LE 
SCS programming and provide data (Per-protocol Analysis Set). Sensitivity analyses will be performed for 
the primary objective using Completer Analysis Set, as well as Implanted Analysis Set with the Multiple 
Imputation (MI) methodology for missing data. Details of the imputation method are described in 
Section 14.4. 
14.1.3 
Multiplicity 
As there is no hypothesis testing for the primary objective, adjustment for multiple endpoints is not 
required. 
14.1.4 
Investigation Site Pooling 
The investigators of this study will conduct the study according to this protocol and use the same CRFs 
to collect study data. The site study personnel will be trained prior to the study initiation at each site. 
Periodic study monitoring by Medtronic will ensure compliance with protocol requirements.  
There is no a priori provision to exclude any sites from the analysis. The data from all sites will be pooled 
for analysis. To reduce the possibility of atypical results from a site overly influencing the combined 
results, no more than 10 subjects will be enrolled at each site. The per-study site enrollment cap may be 
increased upon Sponsor approval.  
14.2 Analysis Execution 
A formal analysis for the DTM-LE SCS study will occur after all subjects complete 3-Month visit. Analysis 
will include both primary and secondary objectives at 3-Month visit. Additional objectives will be 
addressed based on available data. A final report will be prepared once all data collection has ended and 
all subjects have completed the 12-Month visit and have been exited. The analysis for the primary and 
secondary objectives may be updated for the final report if the analysis is performed before final report. 
Additional objectives will be addressed based on complete data. 
14.3 Interim Analysis 
No interim analyses are planned for this study. 
14.4 Primary Objective 
The primary objective is to characterize changes in overall (back and leg) pain intensity, as measured by 
visual analog scale (VAS), from Baseline to 3-Month visit in subjects with devices programmed to DTM-
LE SCS. 
14.4.1 
Hypothesis 
There is no hypothesis testing for the primary objective. The primary objective is to characterize the 
overall pain relief from baseline to 3-Month visit in subjects with DTM-LE SCS.  

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14.4.2 
Endpoint definition and derivation  
The measurements of pain intensity using VAS is described in Section 10.17.1. The overall pain intensity 
as measured by VAS will be collected at both baseline and 3-Month visit. The primary endpoint of 
change in overall pain VAS is calculated using VAS at the 3-Month visit minus VAS at the baseline visit. A 
negative change is an improvement. 
14.4.3 
Analysis Methods  
The change in overall pain VAS as well as overall pain VAS at both baseline and the 3-Month visit will be 
summarized using descriptive statistics, (e.g., mean, standard deviations, etc.). The 95% CI of the mean 
change will be calculated.  
In addition, percentage of change in overall pain VAS will be calculated using change in overall pain VAS 
divided by overall pain VAS at baseline. A negative percentage of change in VAS is a percentage of 
reduction in VAS, thus an improvement. The percentage of change in overall pain VAS will be 
summarized using descriptive statistics, (e.g., median and inter-quartile range, etc.) 
14.4.4 
Determination of Subjects/Data for Analysis  
The primary analysis will use subjects who are implanted with Intellis neurostimulator, follow DTM-LE 
SCS programming, and provide outcome measures at both baseline and 3-Month visit (Per-protocol 
Analysis set). 
Two sensitivity analyses will be performed, one uses Completers Analysis Set and one uses Implanted 
Analysis Set. The sensitivity analysis of all implanted subjects will be performed using MI method for 
missing data at the 3-Month Visit. For scheduled 3-Month visit, if an Unscheduled Visit occurred within 
the 3-Month visit window, and the VAS is collected at the Unscheduled Visit, the VAS from the 
Unscheduled Visit will be used in the analysis of the 3-Month visit. Otherwise, the missing VAS will be 
imputed using MI. Prior to the use of MI, the distributions of the continuous variables will be assessed 
for normality and transformation may be considered if they are not normally distributed. The model 
variables in MI will include study site, subject age, gender, primary diagnosis, VAS at baseline, 1-Month 
visit. The fully conditional specification method with 10 burn-in iterations within SAS and 10 repetitions 
(M = 10) will be used for imputation. Constraints will be set so that the imputed VAS are restricted to 
values ranging from 0-10. Following imputation, the objective will be evaluated using MI analysis 
method.  
14.5 Secondary Objective 
To characterize programming parameters associated with energy use from Device Trial through 12-
Month visit. 
14.5.1 
Hypothesis 
There is no hypothesis testing for the secondary objective. The secondary objective is to characterize 
programming parameters associated with energy use.  
14.5.2 
Endpoint Definition and derivation 
Subject's programmed settings (frequency, pulse width, and amplitude) together with the impedance 
range measurements and cycling ON-OFF time will be summarized.  

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14.8 Sample Size Justification 
The statistical software PASS 11 was used for sample size and precision calculation at 95% confidence 
level (2-sided) using the Confidence Intervals for One Mean module. The precision estimates (the 
distance from mean to limits) by sample size and standard deviation of VAS are provided in Table 14-1. 
Assuming a standard deviation of 2.6 based on internal historical studies, a sample size of 30 subjects 
provides an expected precision of 0.97.  
Table 14-1: Precision by Sample Size and Standard Deviation of VAS 
Sample size 
(N) 
Standard deviation (S) 
2.4 
2.6 
2.8 
3.0 
26 
0.97 
1.05 
1.13 
1.21 
28 
0.93 
1.01 
1.09 
1.16 
30 
0.90 
0.97 
1.05 
1.12 
32 
0.89 
0.94 
1.01 
1.08 
 
With estimated attrition of 40% between enrollment and implant and 10% between implant and 3-
Month from historical internal and external pain studies, to achieve approximately 30 subjects at 3-
Month visit, up to 56 subjects may be enrolled into the study. 
14.9 Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Missing data are a potential source of bias when analyzing study data. A rigorous study design 
and execution will help prevent the incidence of missing data from occurring. All efforts will be 
made to ensure patient follow-ups are completed with limited attrition to ensure 
interpretability of study results. 
• 
To reduce the possibility of atypical results from a site overly influencing the combined results, 
the maximum number of subjects to be enrolled at a single study site is limited to 10 and cannot 
be increased without prior sponsor approval. 
In summary, potential sources of bias that may be encountered in this study have been considered and 
minimized by careful study design. 
15. Ethics 
15.1 Statement(s) of Compliance 
The DTM-LE SCS study will be conducted in accordance with this protocol, the ethical principles that 
have their origin in the Declaration of Helsinki, all applicable regulatory requirements (21CFR§50 
Protection of Human Subjects, 21CFR§56 IRB, and 21CFR§803 Medical Device Reporting) and will comply 
with the concepts of Good Clinical Practices (GCP). The principles of the Declaration of Helsinki have 
been implemented in this study by means of the patient informed consent process, IRB approval, risk 
benefit assessment, study training, clinical trial registration on http://clinicaltrials.gov/, and publication 
policy. Study Investigators will be required to sign an Investigator Agreement stating their intent to 
adhere to applicable regulations.  

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The study will not begin at any site until an IRB letter approving the protocol, the IC, and any other 
subject-facing documents is received by Medtronic.  
16. Study Administration 
16.1 Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this study.  Trained Medtronic 
personnel or delegates appointed by Medtronic may perform study monitoring at the study site in order 
to ensure that the study is conducted in accordance with the CIP, the CTA, and the applicable regulatory 
and local requirements. Medtronic, or delegates, must therefore be allowed direct access to the 
subjects’ case histories (clinic and hospital records, and other source data/documentation) upon request 
as per the IC, Research Authorization (where applicable) and CTA.  The principal investigator should also 
be available during monitoring visits.   
16.1.1 
Monitoring Visits 
Frequency of monitoring visits may be based upon subject enrollment, study compliance, number of 
adverse events, number of deviations, observations from previous monitoring visits and any suspected 
inconsistency in data that requires investigation. Regulatory documents will be reviewed at each study 
site. Monitoring for the study, including site qualification visits, site initiation visits, interim monitoring 
visits, and closeout visits, will be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess study site progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB approval and review of the 
study, maintenance of records and reports, and review of source documents against subject CRFs in 
accordance to the study-specific monitoring plan. Monitors review study site regulatory and study 
compliance by identifying observations of non-compliance and communicating those observations along 
with recommendations for preventative/corrective actions to study site personnel.  Monitors may work 
with study personnel to determine appropriate corrective action recommendations and to identify 
trends within the study or at a particular study site. 
16.2 Data Management 
This study will use the Oracle Clinical Remote Data Capture (RDC) system, which allows the study sites to 
enter data directly to the eCRF in the sponsor’s database over a secure internet connection. This system 
is fully validated and controls user access, ensures data integrity, and maintains audit trails. User access 
to the RDC system will be granted to each individual based on his or her delegation of authority. If a 
person only authorized to complete eCRFs makes changes to an already signed eCRF, the system will 
require the investigator, or authorized delegate, to re-sign the eCRF. The principal investigator will 
ensure that only appropriately delegated study personnel are given access to the electronic eCRF 
system; user IDs and passwords may not be shared. 
Procedures in the CIP require source documentation. Source documentation will be maintained at the 
study site. Source documents, which may include worksheets, subject medical records, programmer 
printouts, and interrogation files, must be created and maintained by the investigational study site 
team.  

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The principal investigator is responsible for the overall quality (completeness and accuracy) of the data 
entered on the eCRFs and in all other required reports. The data reported on the CRFs shall be derived 
from source documents and be consistent with these source documents, and any discrepancies shall be 
explained in writing. See Section 10.19 for CRFs and data collection elements that may be considered 
source. 
Sponsor personnel will perform routine edit and consistency checks, in-house and during monitoring 
visits, for items such as missing data or inconsistent data. Identified data inconsistencies will be resolved 
by use of data queries; investigators and site personnel will review data queries and respond to them in 
a timely manner. The resolved discrepancy will become a part of the eCRF record for the subject. At the 
end of the study, the data will be frozen and will be retained indefinitely by Medtronic. All records and 
other information about subjects participating in this study will be treated as confidential.   
16.3 Direct Access to Source Data/Documents 
Source data are defined as all information in original records, certified copies of original records of 
clinical findings, observations, or other activities in a clinical investigation necessary for the 
reconstruction and evaluation of the clinical investigation. A source document is a printed, optical, or 
electrical document containing source data. Examples of source documents include the following: 
hospital records, laboratory notes, device accountability records, photographic negatives, radiographs, 
records kept at the investigational site, and at laboratories involved in the clinical investigation.  
The principal investigator is responsible for ensuring source data and documents are complete, legible 
and accurate; and entries are made in a timely manner by appropriately delegated study staff.  
The principal investigator and site personnel will provide the Medtronic monitor(s) with direct access to 
source data that support the data on the CRFs as well as other documentation supporting the conduct of 
the study.  
Medtronic or third-party auditors representing Medtronic may perform Quality Assurance audits to 
verify the performance of the monitoring process and study conduct, and to ensure compliance with 
applicable regulations. Representatives for regulatory bodies, such as the FDA, may also perform site 
inspections related to this clinical study. The principal investigator, site personnel, and institution will 
provide auditors with direct access to primary source data and all study-related documentation. 
Medtronic will investigate suspected cases of fraud or misconduct as appropriate. 
16.4 Confidentiality 
All information and data sent to parties involved in study conduct concerning subjects or their 
participation in this study will be considered confidential. Study sites will assign a unique SID to each 
subject. Records of the subject/SID relationship will be maintained by the study site. The SID number is 
to be recorded on all study documents to link them to the subject’s medical records at the study site.  
Confidentiality of data will be observed by all parties involved at all times throughout the clinical 
investigation. All data shall be secured against unauthorized access. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any data.  In the 
US, “Protected Health Information” (PHI) will be maintained in compliance with the HIPAA of 1996. To 
maintain confidentiality, the subject’s name or any other PHI should not be recorded on any study 
document other than the IC. This scenario will be covered in the IC. In the event a subject’s name/PHI is 

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included for any reason, it will be blinded as applicable. In the event of inability to blind the 
identification (e.g., digital media), it will be handled in a confidential manner by the authorized 
personnel.  Data relating to the study might be made available to third parties (for example in case of an 
audit performed by RA), provided the data are treated as confidential and that the subject’s privacy is 
guaranteed. No identifiable subject information will be published. 
16.5 Liability 
Medtronic, Inc. is a wholly owned subsidiary of Medtronic, PLC, which as the parent company of such 
entity maintains appropriate clinical study liability insurance coverage, as applicable and as required 
under applicable laws and regulations and will comply with applicable local law and custom concerning 
specific insurance coverage. If required, a clinical study insurance statement/certificate will be provided 
to the IRB. In addition, subject compensation, indemnification, and insurance may be addressed within a 
separate clinical trial agreement. 
16.6 CIP Amendments 
Amendments to the CIP may be initiated by Medtronic to address changes to the conduct of the study. 
Amendments to the CIP, and associated documents, must be approved by Medtronic and submitted to 
the IRBs for approval prior to implementation except when necessary to eliminate an immediate or 
apparent immediate hazard to participating subjects.  
16.7 Record Retention 
All study-related documents must be retained for a period of at least 2 years after market-release in 
his/her region and after study closure (or longer if required by local law). Medtronic will inform the 
investigator/study site when these documents are no longer required to be retained. 
No study document or image will be destroyed without prior written agreement between Medtronic 
and the investigator. The investigator should take measures to prevent accidental or premature 
destruction of documents. Should the investigator wish to assign the study records to another party or 
move them to another location, advance written notice must be given to Medtronic. 
Medtronic will retain the study records according to Medtronic corporate policy and record retention 
schedule. 
16.7.1 
Investigator Records 
The investigator  is responsible for the preparation and retention of the records cited below. All of the 
below records, with the exception of case history records and case report forms, should be kept in the 
Investigator Site File (i.e., the study binder provided to the investigator) or Subject Study Binder. CRFs 
must be maintained and signed electronically within the electronic data capture system during the 
study. The following records are subject to inspection and must be retained for a period of two years (or 
longer as local law or hospital administration requires) after product approval or the date on which the 
investigation is terminated. 
• 
All correspondence between the IRB, sponsor, monitor, RA and the investigator that 
pertains to the investigation, including required reports.  
• 
Subject’s case history records, including:  
 
Signed and dated IC (In U.S., signed by subject) 

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 
Observations of AEs/ADEs/DDs 
 
Medical history 
 
Implant and follow-up data  
 
Documentation of the dates and rationale for any deviation from the protocol 
• 
Subject ID log 
• 
All approved versions of the CIP and IC  
• 
Signed and dated CTA 
• 
CV of principal investigators and key members of investigation study site team (as 
required by applicable regulations) 
• 
Documentation of delegated tasks  
• 
IRB approval documentation. Written information that the investigator or other study 
staff, when member of the IRB, did not participate in the approval process. Approval 
documentation must include the IRBs composition, where required per local law   
• 
Study training records for study site staff  
• 
Final Study Report including the statistical analysis. 
16.7.2 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records: 
• 
All correspondence which pertains to the investigation 
• 
Sample of label attached to investigational device 
• 
Signed Investigator Trial Agreements and CV of principal investigator and key members 
of the investigation study site team (as required by local law), delegated task list 
• 
All approved IC templates, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all IRB approval letters and relevant IRB correspondence and IRB voting 
list/roster/letter of assurance 
• 
Names of the institutions in which the study will be conducted 
• 
 Monitoring visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the study 
• 
The CIP, study related reports, and revisions 
• 
Study training records for study site personnel and Medtronic personnel involved in the 
study 
• 
Any other records that local regulatory agencies require to be maintained.  
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in stored in secured file cabinets at 
Medtronic during the course of this study.  

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16.9 Publication and Use of Information 
Medtronic may publish the results from the DTM-LE SCS study. These publication activities may include 
abstracts, presentations/posters to scientific meetings, and manuscripts.  Specific requirements 
regarding publication of study data will be provided in the publication plan. All proposed publications 
must be reviewed and approved by Medtronic prior to publication.  If required by a publisher, the 
principal investigator agrees to obtain all necessary authorizations from study subjects prior to 
submitting study-related information for publication. 
16.9.1 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical 
Journal Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org).  Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contributions to conception and design of the work, or the acquisition, 
analysis, or interpretation of data for the work; AND 
• 
Drafting the work or revising it critically for important intellectual content; AND 
• 
Final approval of the version to be published; AND 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved.  
Lead authorship will be given to the principal investigator who meets the criteria listed above and has 
the highest number of evaluable subjects. If there is a tie for lead authorship, the authors will be listed 
in alphabetical order. Medtronic personnel who meet the criteria for authorship will have the right to be 
listed as an author. Other significant contributors to the study who do not meet the criteria for 
authorship will be listed in the acknowledgement section of the publication. 
16.9.2 
Transparency 
Transparency of clinical study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to 
all investigators and IRBs when required by local law 
• 
Registering and posting the study results on a publicly accessible database, e.g., 
ClinicalTrials.gov based on the posting rules stipulated  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g., financial) of the co-authors of publications according 
to the policies set forth by the corresponding journals and conferences  
• 
Making an individual study sites study data accessible to the corresponding investigator 
after the completion of the study, if requested 

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16.10 
Suspension or Early Termination 
16.10.1 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter. Study closure is defined as 
closure of a study that occurs when Medtronic and/or regulatory requirements have been satisfied per 
the CIP and/or by a decision by Medtronic or RA), whichever occurs first. The study closure process is 
complete upon distribution of the Final Report or after final payments, whichever occurs last. Ongoing 
IRB oversight is required until the overall study closure process is complete. Refer to Section 10.21 for 
additional information regarding study exit procedures. 
16.10.2 
Early Termination or Suspension  
Early Termination is the closure of a study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single study site. Suspension is a temporary postponement of study 
activities related to enrollment and distribution of the product. This is possible for the whole study or a 
single study site.  
16.10.2.1 
Study-wide termination or suspension 
Possible reasons for considering study-wide suspension or termination of the study include but are not 
limited to: 
• 
AEs associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or RA (where the study is operating under RA)  
• 
Technical issues during the manufacturing process 
16.10.2.2 
Investigator/study site termination or suspension 
Possible reasons for investigator or study site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a 
timely manner, failure to follow-up on data queries and monitoring observations in a 
timely manner, etc.)  
• 
IRB suspension of the study site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g. no longer able to support the study) 

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16.10.3 
Procedures for Termination or Suspension 
16.10.3.1 
Medtronic-initiated and regulatory authority-initiated 
• 
Medtronic will promptly inform the clinical investigators of the termination or 
suspension and the reasons and inform the RAs where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB 
approval lapse, the investigator will promptly inform the IRB 
• 
In the case of study termination, the investigator must inform the subjects and may 
inform the personal physician of the subjects to ensure appropriate care and follow-up 
is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is 
lifted by Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out 
of consideration of their safety, rights and welfare 
16.10.3.2 
Investigator-initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The investigator will promptly inform the institution (where required per regulatory 
requirements)  
• 
The investigator will promptly inform the IRB 
• 
The investigator will promptly inform the subjects and/or the personal physician of the 
subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out 
of consideration of their safety, rights and welfare 
16.10.3.3 
IRB-initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB policy 
or its determination that an overriding safety concern or ethical issue is involved 
• 
The investigator will inform his/her institution (where required per local requirements)  
• 
The investigator will promptly inform the subjects, or legally-authorized designees or 
guardians and/or the personal physician of the subjects, with the rationale for the study 
termination or suspension 

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17. References 
1. Shatin D, Mullett K, Hults G. Totally Implantable Spinal Cord Stimulation for Chronic Pain: Design 
and Efficacy. PACE 9 (1986) 577-583 
2. Provenzano D, Yu C, Verrills P, Guirguis M, Harrison N, Bradley K. Pulse Dosing of 10 kHz 
Paresthesia-Independent Spinal Cord Stimulation Provides Same Efficacy with Substantial 
Reduction of Device Recharge Time. Abstract 2019 
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World Data Demonstrating The Relationship Between Frequency, Pulse-Width, And Amplitude 
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DTM-LE SCS Study Clinical Investigation Plan 
 
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MDT20042 
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