A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
Conditions: Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia
Sponsor: Abbott Medical Devices



Study Name: 
Infinity MRI PMCF
Clinical Investigation Plan 
 
 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

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TABLE OF CONTENTS 
 
1.0 
INTRODUCTION ........................................................................................................................... 9 
1.1 
Background and Rationale ......................................................................................................... 9 
 
Background ........................................................................................................................ 9 
 
Rationale for Conducting this Clinical Investigation ........................................................... 10 
2.0 
CLINICAL INVESTIGATION OVERVIEW .................................................................................... 10 
2.1 
Clinical Investigation Objective ................................................................................................ 10 
 
Primary objective .............................................................................................................. 10 
2.2 
Device(s) To Be Used in the Clinical Investigation ................................................................... 10 
 
Name of the Device(s) Under Investigation ....................................................................... 10 
 
Intended Indication for Use ............................................................................................... 12 
 
Description of the Device(s) Under Investigation ............................................................... 12 
3.0 
CLINICAL INVESTIGATION DESIGN ......................................................................................... 13 
3.1 
Clinical Investigation Procedures and Follow-up Schedule ...................................................... 14 
3.2 
Measures Taken to Avoid and Minimize Bias ........................................................................... 14 
3.3 
Suspension or Early Termination of the Clinical Investigation .................................................. 15 
4.0 
ENDPOINTS ............................................................................................................................... 15 
4.1 
Primary Endpoint and Rationale .............................................................................................. 15 
4.2 
Secondary Endpoints ............................................................................................................... 16 
4.3 
Additional Safety Endpoint ....................................................................................................... 16 
5.0 
SUBJECT SELECTION AND WITHDRAWAL ............................................................................. 16 
5.1 
Subject Population ................................................................................................................... 16 
5.2 
Subject Screening and Informed Consent ................................................................................ 16 
 
Subject Screening ............................................................................................................. 16 
 
Informed Consent ............................................................................................................. 17 
5.2.2.1 
Special Circumstances for Informed Consent ............................................................ 17 
5.3 
Eligibility Criteria ...................................................................................................................... 18 
 
General Eligibility Criteria .................................................................................................. 18 
 
Inclusion Criteria ............................................................................................................... 18 
 
Exclusion Criteria .............................................................................................................. 18 
5.4 
Subject Enrollment ................................................................................................................... 19 
5.5 
Subject Withdrawal .................................................................................................................. 19 
5.6 
Total Expected Duration of the Clinical Investigation ............................................................... 20 
5.7 
Expected Duration of Each Subject’s Participation ................................................................... 20 
5.8 
Number of Subjects ................................................................................................................. 20 

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6.0 
TREATMENT AND EVALUATION OF ENDPOINTS ................................................................... 20 
6.1 
Enrollment ............................................................................................................................... 20 
6.2 
Baseline Data Collection .......................................................................................................... 21 
6.3 
MRI Procedure ......................................................................................................................... 21 
 
Pre-MRI/MRI Procedure Data Collection/Clinical Assessments (In clinic) ......................... 21 
 
Immediate Post-MRI Procedure (In clinic, after the MRI procedure has been performed) . 22 
6.4 
Follow-up Assessments ........................................................................................................... 22 
 
1 Month Post-MRI Procedure Follow-up (In clinic) ............................................................ 22 
 
Unscheduled visit .............................................................................................................. 23 
 
Non-Study MRI Procedures .............................................................................................. 23 
 
Schedule of Events ........................................................................................................... 24 
7.0 
ADVERSE EVENTS .................................................................................................................... 25 
7.1 
Definition .................................................................................................................................. 25 
 
Adverse Event .................................................................................................................. 25 
 
Serious Adverse Event ..................................................................................................... 25 
7.2 
Device and Procedure Relationship ......................................................................................... 25 
7.3 
MRI Relationship ..................................................................................................................... 26 
7.4 
Adverse Event ......................................................................................................................... 27 
 
Adverse Event Reporting .................................................................................................. 27 
 
Device Deficiency/Malfunction Reporting .......................................................................... 27 
 
Adverse Event Reporting to Country Regulatory Authorities by the Sponsor .................... 28 
 
Procedure for Recording and Reporting Subject Death..................................................... 28 
8.0 
STATISTICAL CONSIDERATIONS ............................................................................................. 28 
8.1 
Analysis Populations ................................................................................................................ 28 
8.2 
Statistical Analyses .................................................................................................................. 28 
 
Primary Endpoint Analysis ................................................................................................ 28 
 
Secondary Endpoint Analysis ........................................................................................... 29 
 
Additional Safety Endpoint ................................................................................................ 29 
8.3 
Sample Size Calculation and Assumptions .............................................................................. 30 
8.4 
Timing of Analysis .................................................................................................................... 30 
8.5 
Subgroup Analysis ................................................................................................................... 30 
8.6 
Procedures for Accounting for Missing Data ............................................................................ 30 
8.7 
Planned Interim Analysis ......................................................................................................... 30 
8.8 
Statistical Criteria for Termination ............................................................................................ 30 
8.9 
Success Criteria ....................................................................................................................... 31 
8.10 
Labeling Claim ......................................................................................................................... 31 

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8.11 
Deviations from Statistical Plan ................................................................................................ 31 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ............................................................... 31 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................... 31 
10.1 
Selection of Clinical Sites and Investigators ............................................................................. 31 
10.2 
Clinical Investigation Finances and Agreements ...................................................................... 31 
10.3 
CIP Amendments ..................................................................................................................... 31 
10.4 
Training.................................................................................................................................... 32 
 
Site Training ..................................................................................................................... 32 
10.5 
Monitoring ................................................................................................................................ 32 
10.6 
Deviations from CIP ................................................................................................................. 32 
10.7 
Quality Assurance Audit ........................................................................................................... 33 
10.8 
Sponsor Auditing ..................................................................................................................... 33 
10.9 
Committees ............................................................................................................................. 33 
 
Clinical Events Committee (CEC) ..................................................................................... 33 
11.0 
DATA HANDLING AND RECORD KEEPING .............................................................................. 34 
11.1 
Protection of Personally Identifiable Information ...................................................................... 34 
11.2 
Data Management Plan ........................................................................................................... 35 
11.3 
Source Documentation ............................................................................................................ 35 
11.4 
Case Report Form Completion ................................................................................................ 35 
11.5 
Record Retention ..................................................................................................................... 35 
12.0 
ETHICAL CONSIDERATION....................................................................................................... 36 
12.1 
Institutional Review Board/Medical Ethics Committee Review and Approval ........................... 36 
13.0 
CLINICAL INVESTIGATION CONCLUSION ............................................................................... 36 
14.0 
PUBLICATION POLICY .............................................................................................................. 36 
15.0 
RISK ANALYSIS ......................................................................................................................... 37 
15.1 
Anticipated Clinical Benefits ..................................................................................................... 37 
15.2 
Foreseeable Adverse Events and Anticipated Adverse Device Effects .................................... 37 
15.3 
Residual Risks Associated with the Device Under Investigation, as Identified in the Risk 
Analysis Report .................................................................................................................................. 37 
15.4 
Risks Associated with Participation in this Clinical Investigation .............................................. 37 
15.5 
Steps Taken to Control or Mitigate Risks ................................................................................. 37 
15.6 
Risk to Benefit Rationale .......................................................................................................... 38 
APPENDIX I: ABBREVIATIONS AND ACRONYMS .............................................................................. 39 
APPENDIX II: DEFINITIONS ................................................................................................................. 40 
APPENDIX III: SITE CONTACT INFORMATION ................................................................................... 41 
APPENDIX IV: REFERENCES .............................................................................................................. 42 

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APPENDIX V: CASE REPORT FORMS ................................................................................................ 43 
APPENDIX VI: INFORMED CONSENT FORM ...................................................................................... 44 
APPENDIX VII: MONITORING PLAN .................................................................................................... 45 
APPENDIX VIII: REVISION HISTORY ................................................................................................... 46 
APPENDIX IX: LABELING ..................................................................................................................... 47 
APPENDIX X: CIP SUMMARY .............................................................................................................. 48 
 
 

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COMPLIANCE STATEMENT:  
 
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, the 
Declaration of Helsinki, applicable Good Clinical Practices (GCP) and regulations (e.g., US 21 CFR Part 
50, 21 CFR Part 56, 21 CFR Part 812 and OUS ISO14155:2011) and the appropriate local legislation(s). 
The most stringent requirements, guidelines or regulations must always be followed. The conduct of the 
clinical investigation will be approved by the appropriate Institutional Review Board (IRB)/Ethics 
Committee (EC) of the respective investigational site and by the applicable regulatory authorities. 
 
 

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1.0 
INTRODUCTION 
This protocol outlines the multicenter, prospective, post-market clinical follow-up (PMCF) plan to support 
the safety of St Jude Medical InfinityTM deep brain stimulation (DBS) systems with MR Conditional 
labeling. The study will be conducted at up to 25 centers in geographies where Infinity DBS systems with 
MR Conditional labeling are approved including the European Union and the United States, results of 
which will be submitted to the European Union Notified Body. 
 
The rate of magnetic resonance imaging (MRI) procedure-related adverse events will be used to support 
the safety of Infinity DBS systems with MR Conditional labeling when used in compliance with the 
approved requirements. All MRI procedures and the recommended MRI procedural workflow in this 
clinical investigation should be followed using the DBS MRI Procedure Information Clinican’s Manual to 
ensure patient and device safety during and after the MRI procedure.  
This clinical investigation will be conducted in accordance with this clinical investigation plan (CIP). All 
investigators involved in the conduct of the clinical investigation will be qualified by education, training, or 
experience to perform their tasks and this training will be documented appropriately. 
1.1 
Background and Rationale 
 Background 
Deep brain stimulation has demonstrated long-term efficacy in the management of advanced Parkinson’s 
disease (PD)1-6 and other movement disorders such as tremor and dystonia.7-10 This is accomplished by 
sending continuous electrical signals to specific target areas, which modulate the activity of the basal 
ganglia circuitry. DBS is reversible and can be tailored to a patient’s clinical status (parameters are 
adjustable allowing for minimization of stimulation induced side effects and improvements in efficacy over 
time), and the system can provide continuous symptom control 24 hours a day with minimal patient and 
physician involvement.5,11-14 The electrodes and electrical systems that provide stimulation are generally 
well tolerated with no significant changes in surrounding brain tissue.10 
 
Magnetic resonance imaging is an imaging modality that allows visualization of two and three 
dimensional images of the body. MRI systems generate three electromagnetic fields that are used to 
produce an image. These include a static magnetic field, a time varying gradient magnetic field and a 
radiofrequency field. All three of these fields interact with implanted devices and could create hazards for 
the device, the patient or both. Due to these issues, currently marketed implantable pulse generators 
(IPGs), leads or accessories may be contraindicated for use in a MRI environment. 
 
St Jude Medical has developed MR Conditional neurostimulation systems, designed to mitigate such 
interactions. The systems provide the option for conditionally safe scanning of patients requiring an MRI. 
Centers that are qualified will be approached to participate in the DBS MRI PMCF to support MR 
Conditional labeling of the Infinity DBS system.  
 
According to Sharan et al15 MRI is a necessary imaging modality in the management of DBS patients 
throughout the course of the therapy. For example, MRI is typically used as part of surgical planning, 
may be used post-operatively to verify lead location, and is required in rare circumstances in which 
clinical outcome is poor or results in significant side effects.15-17 Furthermore, due to the progressive 
nature of neurological diseases such as Parkinson’s disease, patients implanted with DBS may require 
multiple MRIs to monitor chronic symptoms or to evaluate other co-morbidities such as stroke, neoplasm, 

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or infectious diseases.15 The increasing importance of MRI is expected to continue to rise and 
underscores the need for an MR Conditional neurostimulation system for DBS applications.  
The Infinity DBS system used in this PMCF received CE mark on October 19, 2018. Patients can 
undergo MRI procedures using one of two device configurations: a leads-only configuration and a full 
system configuration. The leads-only configuration consists of at least one implanted lead connected to a 
lead protection boot, as well as an optional cranial burr hole cover. The full system configuration consists 
of at least one IPG, one lead, one extension, and an optional cranial burr hole cover. For subjects with 
the lead-only configuration, the lead(s) are completely implanted, have a lead protection boot on the 
proximal end of the lead, and the surgical incision is closed.  
 Rationale for Conducting this Clinical Investigation 
MRI is an imaging modality used in treatment or diagnosis of many conditions, and could also be used 
for DBS lead location verification. DBS systems have been shown to be beneficial for patients with 
Parkinson’s disease, tremor, and dystonia but may be contraindicated for MRI, requiring an imaging 
method that is less optimal. This study will support the claim that MRI procedures are safe when 
performed according to the approved guidance. MR Conditional safety improves patient care for other 
conditions and reduces patient burden.  
2.0 
CLINICAL INVESTIGATION OVERVIEW 
2.1 
Clinical Investigation Objective 
 Primary objective  
The primary objective of the DBS MRI PMCF is to support the safety of the Infinity DBS system with MR 
Conditional labeling.  
2.2 
Device(s) To Be Used in the Clinical Investigation 
 Name of the Device(s) Under Investigation 
The components of the Infinity DBS system with MR Conditional labeling under this investigation are 
listed in Table 1. The MR Conditional components of the system are shown in Figure 1 and non-MR 
Conditional components (external devices) are shown in Figure 2. 
 
 

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Figure 2: External components of the Infinity DBS system that are MR Unsafe. Left to right: Artemis 
Clinician Programmer App, Artemis Patient Controller App. 
 
 
 Intended Indication for Use 
The indications for use in the European Union for the Infinity DBS system with MR Conditional labeling 
are: 
 
Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic 
nucleus (STN) in patients with levodopa-responsive Parkinson’s disease. 
 
Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus 
(STN) for the management of intractable, chronic dystonia, including primary and secondary 
dystonia, for patients who are at least 7 years old. 
 
Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the 
management of disabling tremor. 
Please refer to the instructions for use (IFU) for locally approved indications for use. 
 Description of the Device(s) Under Investigation 
The Infinity DBS system with MR Conditional labeling includes a primary cell implantable pulse generator 
designed to deliver low-intensity electrical pulses to targeted structures in the brain. A DBS 8-channel 
lead containing electrodes at the distal end is placed in the target brain structures, and is connected to 
the IPG via a DBS 8-channel extension. Up to 2 leads and extensions can be connected to the IPG. The 
electrical pulses travel from the IPG through the lead and extension, to electrodes placed near selected 
nerve fibers in order to provide therapeutic stimulation to patients suffering from movement disorders.  
The stimulation settings can be controlled wirelessly and are programmed over Bluetooth using the 
Artemis patient controller and Artemis clinician programmer. A DBS Lead Protection Boot is applied to 

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the terminal end of a DBS lead during staged implantation to protect the lead from damage and to allow 
for palpation of the terminal end of the lead through the scalp. Guardian Burr Hole cover is an accessory 
to the DBS system that is intended for use during cranial surgery as an implantable burr hole cover for 
the skull that can be used to secure the implanted lead. The product labeling describes the conditions for 
scanning patients requiring an MRI. 
Please refer to the instructions for use (IFU) for additional information regarding the device used in this 
clinical investigation. 
3.0 
CLINICAL INVESTIGATION DESIGN 
This study will be conducted as an international, multicenter, observational, prospective, single-arm, 
post-market clinical follow-up (PMCF). The study will evaluate the safety of the Infinity DBS system with 
MR Conditional labeling when an MRI procedure is performed according to the approved guidance. The 
results of this study will be submitted to the notified body. 
 
The study will be conducted at centers that are qualified to participate and will enroll up to 74 subjects at 
up to 25 centers in geographies where Infinity DBS systems with MR Conditional labeling are approved 
including the European Union and the United States. A minimum of 10 centers will be included to ensure 
a range of MRI equipment brands, including a minimum of 6 in the European Union. Each site will have a 
maximum enrollment capped at 20% of total enrollment.  Subjects who have a leads-only configuration 
or a full system configuration will participate in the study. Subjects may be enrolled when an MRI 
procedure is prescribed per standard of care.  
 
Each subject will be limited to one MRI procedure during the course of the study. Selected sites will have 
this protocol approved to allow for data collection of the MRI parameters and any adverse events (AEs) 
that occur during the procedure and through 1-month following the procedure. An office visit will be 
added for all subjects for a 1-month (30 days ± 14 days) post-MRI follow-up visit after the initial MRI 
procedure is performed.    
 
The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other 
foreseeable risk as possible for subjects. Refer to the Risks Analysis section of this clinical investigation 
plan for details.     
 

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3.3 
Suspension or Early Termination of the Clinical Investigation 
Because this study is used to support safety of the Infinity DBS system with MR Conditional labeling, no 
formal statistical rule for early termination of the clinical investigation for insufficient effectiveness of the 
device under investigation is defined.  
 
The Sponsor reserves the right to discontinue the clinical investigation at any stage or reduce the follow-
up period with suitable written notice to the investigator. Possible reason(s) may include, but are not 
limited to: 
 
Unanticipated adverse device effect (e.g., UADE) occurs and it presents an unreasonable risk to 
the participating subjects 
 
Any oversight committee (e.g., Steering/Executive Committee, Data Monitoring Committee) 
makes a recommendation to stop or terminate the clinical investigation (such as higher frequency 
of anticipated adverse device effects) 
 
Further product development is cancelled and MR Conditional labeled product will be removed 
from the market 
 
Should the clinical investigation be discontinued by the Sponsor, subjects will be followed per routine 
clinical practice with device-related AEs reported to the Sponsor as per vigilance/commercial reporting 
requirements. 
 
Should this occur, the investigator shall return all clinical investigation materials (including devices) to the 
Sponsor, and provide a written statement as to why the premature termination has taken place to the 
IRB/EC (if applicable). All applicable clinical investigation documents shall be subject to the same 
retention policy as detailed in Section 11.5 of the CIP.  
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical investigation at the investigational sites for which they are responsible. The 
investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual site in the 
interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Principal Investigator or authorized designee will 
promptly inform the enrolled subjects at his/her site, if appropriate, and return patients to their standard 
medical treatment. 
4.0 
ENDPOINTS 
4.1 
Primary Endpoint and Rationale 
The primary endpoint is the rate of MRI-related adverse events. This endpoint was selected as the 
primary goal of the study is to support safety of Infinity DBS systems with MR Conditional labeling when 
undergoing a MRI procedure according to the approved guidelines defined in the MRI Procedure 
Information Clinician’s Manual. A description of adverse events for inclusion in the primary endpoint is 
provided in section 8.2.1. 

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4.2 
Secondary Endpoints 
The following secondary endpoints are for subjects undergoing an MRI procedure with the full system 
configuration. 
 
Rate of successful MRI mode ‘turn on/off’ functionality of the MRI mode 
 
Rate of successful ‘turn on/off’ functionality for the stimulation 
 
Rate of successful adjustments to the stimulation amplitude 
 
Rate of successful interrogation and download of the IPG parameters  
 
Rate of successful ability to obtain lead impedance measurements 
4.3 
Additional Safety Endpoint 
Characterization of all MRI-related adverse events. 
5.0 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 
Subject Population   
This clinical investigation will enroll male and female subjects with levodopa-responsive Parkinson’s 
disease, primary or secondary dystonia, or disabling tremor, and have been, or will be, implanted with 
the Infinity DBS system with MR Conditional labeling. Subjects must meet all eligibility criteria and 
provide written informed consent prior to conducting any investigation-specific procedures.  
5.2 
Subject Screening and Informed Consent 
 Subject Screening  
Potential patients presenting at the clinical sites will be fully informed about the clinical investigation, 
following the established Informed Consent process (described in Section 5.2.2).  
The following assessments will be performed as part of the screening process: 
 
Ensure subject has, or is scheduled to have, an Infinity DBS system implanted, per locally 
approved indications for use 
 
Ensure subject is willing to undergo an MRI procedure without sedation (ensure subject is not 
claustrophobic). Note: Anti-anxiety agents may be used as long as the patient can communicate 
with the site personnel during the MRI procedure. 
 
Subject is able to come into the clinic or office for an MRI procedure, and can come back for 
follow-up visits as needed 
 
Other assessments, as needed. See Eligibility Criteria (Section 5.3) or the patient eligibility 
criteria in the MRI Procedure Information Clinician’s Manual for more information.  
 
Subjects must be screened for clinical investigation eligibility by a member of the site’s clinical 
investigation team (physician and/or research coordinator) previously trained to the CIP. 
 
In case the subject does not meet all inclusion criteria or meets any of the exclusion criteria, the subject 
is considered a screening failure. The Principal Investigator or the delegated clinical investigation 
personnel will record the screening failure in the hospital records and on a screening log as required. 
 

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Subjects who meet all inclusion criteria and no exclusion criteria will be asked to sign an Informed 
Consent form if they wish to participate in the clinical investigation. Once a duly dated and signed 
Informed Consent form is obtained, the clinical investigation-specific procedures may begin. 
 
Subject data will be collected following enrollment into the clinical investigation. 
 Informed Consent 
The Investigator or his/her authorized designee will conduct the Informed Consent process, as required 
by applicable regulations and the center’s IRB/EC. This process will include a verbal discussion with the 
subject on all aspects of the clinical investigation that are relevant to the subject’s decision to participate, 
such as details of clinical investigation procedures, anticipated benefits, and potential risks of clinical 
investigation participation. Subjects must be informed about their right to withdraw from the clinical 
investigation at any time and for any reason without sanction, penalty or loss of benefits to which the 
subject is otherwise entitled. Withdrawal from the clinical investigation will not jeopardize their future 
medical care or relationship with the investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper 
influence on the subject and will respect subject’s legal rights. Financial incentives will not be given to the 
subject. Subjects may be compensated for time and travel directly related to the participation in the 
clinical investigation. The subject shall be provided with the Informed Consent form written in a language 
that is understandable to the subject and has been approved by the center’s IRB/EC. The subject shall 
have adequate time to review, ask questions and consider participation. The Principal Investigator or 
his/her authorized designee will make efforts to ensure that the subject understands the information 
provided. If the subject agrees to participate, the Informed Consent form must be signed and dated by 
the subject and thereafter by the person obtaining the consent prior to any clinical investigation-specific 
procedures. The signed original will be filed in the subject’s hospital or research charts, and a copy will 
be provided to the subject. 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment should be 
reported to Sponsor within 5 working days and to the reviewing center’s IRB/EC according to the 
IRB/EC’s reporting requirements. 
 
If, during the clinical investigation, new information becomes available that can significantly affect a 
subject's future health and medical care, the Principal Investigator or his/her authorized designee will 
provide this information to the subject. If relevant, the subject will be asked to confirm their continuing 
informed consent in writing. 
5.2.2.1 Special Circumstances for Informed Consent 
 
Individuals under age of 18 or age of legal consent 
Individuals who are minors (under the age of 18 or age of legal consent) may be enrolled in this clinical 
investigation. Informed consent must be obtained using the IRB/EC approved informed consent in 
accordance with IRB/EC requirements. The clinical investigation directly relates to a medical condition 
affecting the minor, or is such that it can only be carried out on minors. Additionally, the clinical 
investigation is expected to product a direct benefit to the individual, outweighing the risks and burdens 
involved. 
 
If the subject is a minor, the legally acceptable representative will represent the individual during the 
Informed Consent process, which will be performed according to the requirements in section 5.2.2. The 

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minor will also be informed about the clinical investigation within his/her ability to understand. The explicit 
wish of the minor who can form an opinion and assess information to decline participation or withdraw 
from the clinical investigation at any time will be respected. 
 
If the minor reaches 18 or the age of legal competence during the clinical investigation, informed consent 
will be obtained before the individual continues in the clinical investigation.  
 
Individuals unable to read or write 
Individuals unable to read or write may be enrolled in this clinical investigation. 
 
Informed consent will be obtained through a supervised oral process. An independent witness will be 
present throughout the Informed Consent process. The written Informed Consent form and any other 
information will be read aloud and explained to the prospective subject or his/her legally acceptable 
representative and either will sign and personally date the Informed Consent form. The witness will also 
sign and personally date the Informed Consent form attesting that the information was accurately 
explained and that informed consent was freely given. 
 
Incapacitated individuals, defined as mentally ill, mentally handicapped, or individuals without 
legal authority 
Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals 
without legal authority, are excluded from the study population. 
 
Pregnant or breastfeeding women 
Pregnant or breastfeeding women are excluded from the study population. 
5.3 
Eligibility Criteria 
 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a 
candidate patient. If some of the clinical and laboratory tests are not included in site standard tests, they 
must be done but after written informed consent is obtained. Patients must meet ALL of the inclusion 
criteria to be considered for the clinical investigation. If ANY of the exclusion criteria are met, the patient 
is excluded from the clinical investigation and cannot be enrolled. 
 Inclusion Criteria 
1. Subject or subject’s legally acceptable representative must provide written informed consent prior 
to any clinical investigation related procedure. 
2. Subject has been implanted, or is scheduled to be implanted, with a commercially available 
Infinity DBS system with MR Conditional labeling per locally approved indications for use. 
3. Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure 
Information Clinican’s Manual. Anxiolytics and patient’s regular medications may be administered, 
provided IFU criteria are met. 
4. Subject is willing and able to comply with study requirements. 
 Exclusion Criteria 
1. Subject has another implanted device (active or passive implanted device) that prohibits safe 
scanning. 

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2. Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any 
other reason. 
3. Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation 
follow-up period.  
4. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological 
conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the 
clinical investigation or to comply with follow-up requirements, or impact the scientific soundness 
of the clinical investigation results. 
5. Subject is currently participating in another clinical investigation that may confound the results of 
this study. 
5.4 
Subject Enrollment 
A patient is considered enrolled in the clinical investigation from the time the patient provides written 
informed consent. 
5.5 
Subject Withdrawal 
Each enrolled subject shall remain in the clinical investigation until completion of the required follow-up 
period; however, a subject’s participation in any clinical investigation is voluntary and the subject has the 
right to withdraw at any time without penalty or loss of benefit. Conceivable reasons for discontinuation 
may include, but not be limited to, the following: 
 
Subject death (cause must be documented) 
 
Subject does not meet the inclusion/exclusion criteria and does not require additional follow-up 
 
Subject voluntary withdrawal  
 
Subject non-compliance 
 
Subject’s participation is terminated by the PI or co-investigator 
 
Subject lost-to follow-up as described below  
 
Subject’s follow-up is terminated according to Section 3.3. 
 
The Sponsor must be notified of the reason(s) for subject discontinuation. The site will provide this 
information to the Sponsor. Investigators must also report this to their respective IRB/EC as defined by 
their institution’s procedure(s).  
 
No additional follow-up will be required or data recorded from subjects once withdrawn from the clinical 
investigation, except for the status (deceased/alive) at the time of withdrawal, if not previously collected. 
 
However, if a subject withdraws from the investigation due to problems related to the safety or 
performance of the device under investigation, the investigator shall ask for the subject's permission to 
follow his/her status/condition outside of the clinical investigation as appropriate. 
 
Lost-to-Follow-up 
 
A subject is considered lost-to-follow-up if the subject does not adhere to the scheduled follow-up visit 
but has not explicitly requested to be withdrawn from the clinically study. Site personnel shall make all 

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Record enrollment information (date of consent and inclusion/exclusion information) in the hospital 
records and complete the enrollment form, preferably within 5 days of enrollment. 
 
As soon as the patient signs the Subject Informed Consent Form, adverse events need to be reported 
according to the guidelines mentioned in this CIP [section 7.0]. 
 
In case the subject was consented to participate in the study, but is later found to not meet 
inclusion/exclusion criteria, and did not undergo an MRI procedure, the subject should be withdrawn and 
a withdrawal form must be completed. The subject will resume his/her regular standard of care with 
his/her physician. 
 
In case the subject was consented to participate in the study and did undergo an MRI procedure, but 
does not meet inclusion/exclusion criteria, it is considered a protocol deviation. A protocol deviation form 
needs to be completed and the sponsor must be informed. The subject will be followed through the 1 
month visit. 
6.2 
Baseline Data Collection 
There is no minimum required time between implantation of the device and the MRI procedure. This will 
be determined by the physician based on the subject’s standard of care. The following data will be 
collected at baseline: 
 
Subject demographics 
 
Medical condition for performing an MRI procedure 
 
Medical indication for having received/receiving DBS 
 
Adverse events  
 
Protocol deviations (if applicable) 
 
Withdrawal (if applicable) 
 
Device deficiency (if applicable) 
 
Product out of service data (if applicable) 
6.3 
MRI Procedure  
The MRI procedure will take place at an appropriate facility.  The MRI procedure must be performed 
according to the guidelines outlined in the MRI Procedure Information Clinician’s Manual. 
 Pre-MRI/MRI Procedure Data Collection/Clinical Assessments (In clinic) 
Subjects will be screened to ensure that they are eligible to undergo an MRI procedure. The following 
data will be collected before the MRI procedure: 
 
Subject eligibility for MRI procedure 
 
DBS lead(s) information 
 
Adverse events 
 
Protocol deviations (if applicable) 
 
Withdrawal (if applicable) 
 
Device deficiency (if applicable) 
 
Product out of service data (if applicable) 
 

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For subjects in the full system configuration group, the following additional data will be collected: 
 
DBS extension and DBS IPG information 
 
Success or failure of ‘turn on’ functionality of MRI mode  
 
Success or failure to ‘turn on/off’ functionality of the stimulation 
 
Success or failure to make adjustments to the stimulation amplitude 
 
Success or failure of device interrogation and download of IPG parameters 
 
Success or failure to obtain lead impedance measurements (only if the Clinician Programmer is 
being used to interrogate the IPG) 
 Immediate Post-MRI Procedure (In clinic, after the MRI procedure has been performed) 
The following data will be collected after the MRI procedure: 
 
MRI scanner manufacturer/model 
 
Scan region (anatomic location) 
 
Subject position during MRI procedure 
 
Static field strength 
 
RF coil type 
 
RF power 
o B1+RMS, head SAR, and/or whole body SAR, if applicable 
o Duration of each scan   
 
Total active scan time  
 
DICOM image files (de-identified), if available 
 
Adverse events  
 
Protocol deviations (if applicable) 
 
Withdrawal (if applicable) 
 
Device deficiency (if applicable) 
 
Product out of service (if applicable) 
 
For subjects in the full system configuration group, the following additional data will be collected 
immediately after the MRI procedure: 
 
Success or failure of ‘turn off’ functionality of MRI mode 
 
Success or failure to ‘turn on/off’ functionality of the stimulation  
 
Success or failure to make adjustments to the stimulation amplitude  
 
Success or failure of device interrogation and download of IPG parameters 
Success or failure to obtain lead impedance measurements (only if the Clinician Programmer is 
being used to interrogate the IPG) 
6.4 
Follow-up Assessments  
 1 Month Post-MRI Procedure Follow-up (In clinic) 
The only follow-up visit for all subjects in this study will be scheduled for 30 days ± 14 days after the MRI 
procedure. The follow-up visit will be conducted in the clinic and data collection will include:  
 
For subjects with a full DBS system implanted (includes subjects in the full system configuration 
group and subjects in the leads-only group who had an IPG implanted and connected to at least 
one lead after the MRI procedure): 
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o Success or failure to make adjustments to the stimulation amplitude  
o Success or failure of device interrogation and download of IPG parameters 
o Success or failure to obtain lead impedance measurements (only if the Clinician 
Programmer is being used to interrogate the IPG) 
 
Adverse events  
 
Protocol deviations (if applicable) 
 
Withdrawal (if applicable) 
 
Device deficiency (if applicable) 
 
Product out of service data (if applicable) 
 Unscheduled visit 
Subjects may be asked or need to return to the clinic before the 1 month visit to assess various program 
parameters or undergo additional surgery to replace, reposition/revise or explant the DBS component(s) 
or system. This is considered an unscheduled visit. An IPG implant procedure for the Leads-Only group 
occurring after the MRI procedure is acceptable and will also be considered an additional surgery. If an 
unscheduled visit occurs, the following information will be recorded: 
 
Reason for visit 
 
Action taken 
 
Adverse events 
 
Session records, if (re)programmed 
 
Additional surgery information (if applicable) 
 
Protocol deviation (if applicable) 
 
Withdrawal (if applicable) 
 
Device deficiency (if applicable) 
 
Product out of service data (if applicable) 
 Non-Study MRI Procedures 
In some cases, a non-study MRI procedure may be medically necessary. A non-study MRI procedure is 
defined as an MRI scan occurring after the study MRI procedure but prior to the 1 month follow-up visit. 
Non-study MRI procedures should be performed according to the center’s standard of care.  
For non-study MRI procedures, the same safety precautions outlined in the MRI Procedure Information 
Clinican’s Manual should be followed. However, data for the non-study MRI procedures will not be 
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7.0 
ADVERSE EVENTS 
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
7.1 
Definition 
 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the medical device under investigation. 
 
Note 1: This definition includes events related to the medical device under investigation or the 
comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices under 
investigation. 
 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
 
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function, or 
5. chronic disease 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a 
serious deterioration in health, is not considered to be an SAE. 
7.2 
Device and Procedure Relationship 
Determination of whether there is a reasonable possibility that the device under investigation or the DBS 
procedure (if applicable) caused or contributed to an AE is to be determined by the Investigator and 
recorded on the appropriate case report form (CRF). Determination should be based on assessment of 
temporal relationships, evidence of alternative etiology, medical/biologic plausibility, and patient condition 
(pre-existing condition). 
 

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7.4 
Adverse Event  
 Adverse Event Reporting 
General AE Reporting 
 
Safety surveillance and reporting starts as soon as the patient is enrolled in the clinical investigation. 
Safety surveillance and reporting will continue until the one month follow-up visit has been performed, 
the subject is deceased, the subject concludes participation in the clinical investigation or the subject 
withdraws from the clinical investigation, whichever comes first. All adverse event data will be collected 
throughout the time period defined above and will be reported to the Sponsor on a CRF. Additional 
information with regard to an adverse event should be updated within the appropriate CRF.  
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
 
An offline form will be made available to allow the investigator to report SAEs in the event the entry 
cannot be made in the electronic data capture (EDC) system. This does not replace the EDC reporting 
system. All information must still be entered in the EDC system as soon as feasible. 
 
SAE Reporting 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than outlined 
below.  
 
Clinical Site
Reporting timelines
All Sites 
SAEs must be reported to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event or as per the site’s local 
requirements, if more stringent than 3 calendar datys.
 
The date the site staff became aware the event met the criteria of an SAE must be recorded in the 
source document.  The Investigator will further report the SAE to the local IRB/EC according to the local 
IRB/EC reporting requirements. 
 
Reportable events to the sponsor are considered:  
 
All serious adverse events regardless of relatedness to the device and/or implant procedure 
 
All device- or implant procedure-related adverse events 
 
All MRI-related adverse events 
 
Refer to the specific device manuals for the adverse events that are associated with implanting or using 
the neurostimulation system for DBS and for MRI related adverse events. 
 Device Deficiency/Malfunction Reporting  
All device deficiencies/malfunctions should be reported on the appropriate CRF. The investigator should 
report all device deficiencies/malfunctions to the Sponsor as soon as possible but no later than 3 
calendar days from the day the site personnel became aware of the event or as per the site’s local 
requirements, if more stringent than 3 calendar days.  
 
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An offline form will be made available to allow the investigator to report device deficiencies/malfunctions 
in the event that the entry cannot be made in the EDC system. This does not replace the EDC reporting 
system. All information must still be entered in the EDC system as soon as feasible. 
 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report SAEs to the country regulatory authority, per local requirements.  
 
 Procedure for Recording and Reporting Subject Death 
Should death occur, the investigator is requested to record death information in the hospital records and 
immediately document the information on the AE case report form and submit to Sponsor. The 
investigator should report the death as soon as possible and per the reporting timeline for SAEs in 
section 7.4.1. 
 
All efforts to obtain the details about the circumstances surrounding the patient death should be 
made by the Investigator. 
The subject’s death is an outcome of an AE and an early conclusion of the subject’s participation in the 
clinical investigation. Therefore, the Investigator is required to complete the Withdrawal form. 
8.0 
STATISTICAL CONSIDERATIONS 
The following section describes the statistical methods for the clinical investigation. Additional details on 
statistical analyses, including justification of clinical investigation design, and analysis of additional 
endpoints, may be maintained in a separate Statistical Analysis Plan (SAP). 
8.1 
Analysis Populations 
All subjects who have signed a Subject Informed Consent Form will be considered enrolled in the clinical 
investigation. However, it is anticipated that there will be subjects who are enrolled in the study, but will 
not be included in the primary endpoint analysis, such as: 
 
Subjects who are enrolled, but do not meet inclusion criteria or meet exclusion criteria and do not 
undergo and MRI procedure; these subjects will be withdrawn from the study. 
 
Subjects who are enrolled, but do not undergo an MRI procedure; these subjects will be 
withdrawn from the study. 
8.2 
Statistical Analyses  
 Primary Endpoint Analysis 
The primary endpoint is the event rate of MRI-related adverse events through 1 month post-MRI 
procedure. The clinical acceptance criterion for the rate of MRI-related adverse events is 7%, drawn from 
historical rates of significant adverse events in DBS studies. The endpoint will be evaluated for each 
group and will be reported as the percentage of subjects experiencing the events. The clinical 
acceptance criterion must be satisfied in both groups (leads-only and full system). 
 
The primary analysis will be conducted on subjects who meet all of the following criteria:  
 
Signed informed consent 

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 
Met the MRI procedure eligibility requirements at the time of the MRI procedure (as per the MRI 
Procedure Clinician’s manual) 
 
Had a study MRI procedure 
Any adverse event will be included in the primary endpoint analysis if it: 
1. Is classified as being MRI-related (as determined by the CEC), occurs during or after the MRI 
procedure, and cannot be attributed to any other cause; and 
2. Is classified as being related to the device (implanted or external component) (as determined by 
the Investigator); and 
3. Meets the criteria for serious adverse event or is a non-serious adverse event that is the result of 
irrecoverable failure of therapy delivery or device communication. 
Examples of MRI-related adverse events that will be included in the primary endpoint analysis are: 
 
Symptomatic intracranial hemorrhage that cannot be attributed to the implant procedure. 
 
New and permanent neurological symptoms that cannot be attributed to a cause other than the 
MRI procedure. 
 
Lack of therapeutic benefit due to damage to the IPG requiring device replacement (e.g., 
stimulation cannot be turned on following the MRI procedure, stimulation cannot be adjusted 
following the MRI procedure). 
 
Examples of adverse events that may be reported but will not be included in the primary analysis are:  
 
Transient, non-serious complications such as sensory or motor disturbance during the MRI 
procedure that may result from induced currents on leads. 
 
Sensation of warmth at the IPG that resolves following the MRI procedure. 
 
Pain around the implanted IPG site that could be related to the implant procedure. 
 Secondary Endpoint Analysis 
The following secondary endpoints will be analyzed for subjects who undergo an MRI procedure with a 
full system configuration. The endpoint “Rate of successful ability to obtain lead impedance 
measurements” will include only those subjects who had their IPG interrogated using the Clinician 
Programmer. Data (success or failure) for these endpoints will be collected immediately after the MRI 
procedure. 
 
Rate of successful MRI mode ‘turn on/off’ functionality of the MRI mode 
 
Rate of successful ‘turn on/off’ functionality for the stimulation 
 
Rate of successful adjustments to the stimulation amplitude 
 
Rate of successful interrogation and download of the IPG parameters  
 
Rate of successful ability to obtain lead impedance measurements 
Rates will be reported as the percentage of subjects in which the device functionality could be 
successfully completed. 
 Additional Safety Endpoint 
The frequency of all MRI-related adverse events will be reported as the number of occurrences of each 
event and the percentage of subjects experiencing each event, and will be summarized in table format. 

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8.3 
Sample Size Calculation and Assumptions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
8.4 
Timing of Analysis 
Analysis of the primary endpoint and additional endpoints will occur once all subjects have either 
completed the 1-month follow-up or withdrawn from the study.  
8.5 
Subgroup Analysis 
No subgroup analyses are planned for this clinical investigation.  
8.6 
Procedures for Accounting for Missing Data 
No imputation techniques will be used in this study. 
8.7 
Planned Interim Analysis 
Interim analysis will not be conducted; however the CEC will review and adjudicate events periodically 
until the study is completed. 
8.8 
Statistical Criteria for Termination 
There are no statistical criteria for termination of this clinical investigation. 

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8.9 
Success Criteria 
The clinical investigation is successful if the primary endpoint is met for both the lead-only configuration 
group and the full DBS system group. 
8.10 Labeling Claim  
This Post-Market Clinical Follow up (PMCF) supports the safety of the Infinity DBS system with MR 
Conditional Labeling. 
8.11 Deviations from Statistical Plan 
Any major changes to the statistical plan will be documented in an amendment to the statistical plan. 
Less significant changes to the planned analyses will be documented in the final report.   
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution will permit direct access to source data/documents for the purpose of 
performing clinical investigation-related monitoring, audits, IRB/EC review and regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow clinical investigation monitors or regulatory 
authorities to review, in confidence, any records identifying the subjects in this clinical investigation. This 
information may be shared with regulatory agencies; however, Sponsor undertakes not to otherwise 
release the subject's personal and private information. 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the clinical 
investigation. Sites will be selected based upon review of a recent site assessment, if applicable, and the 
qualifications of the investigators who will participate in the clinical investigation. 
10.2 Clinical Investigation Finances and Agreements 
The clinical investigation is fully financed by the Sponsor. The Sponsor will establish written agreements 
with the sites before patient enrollment. 
10.3 CIP Amendments  
Approved CIP amendments will be provided to the Investigators by the Sponsor prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the IRB/EC or equivalent committee of 
the CIP amendment (administrative changes) or obtaining IRB/EC’s approval of the CIP amendment 
(changes in subject care or safety), according to the instructions provided by the Sponsor with the CIP 
amendment.   
 

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Acknowledgement/approval by the IRB/EC of the CIP amendment must be documented in writing prior to 
implementation of the CIP amendment. Copies of this documentation must also be provided to the 
Sponsor. 
10.4 Training 
 Site Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training sessions, 
which may be conducted at an Investigator's meeting, a site initiation visit or other appropriate training 
sessions. Over-the-phone or self-training may take place as required. Training of Investigators and 
clinical investigation personnel will include, but is not limited to, the CIP requirements, MR Conditional 
labeling for the Infinity DBS system, electronic case report form completion and clinical investigation 
personnel responsibilities. All Investigators and clinical investigation personnel that are trained must sign 
a training log (or an equivalent) upon completion of the training. Prior to signing the training log, 
Investigators and clinical investigation personnel must not perform any CIP-related activities that are not 
considered standard of care at the site.  
10.5 Monitoring  
Sponsor and/or designee will monitor the clinical investigation over its duration according to the CIP-
specific monitoring plan which will include the planned extent of source data verification.  
 
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following criteria 
are met: 
 
The investigator understands and accepts the obligation to conduct the clinical investigation 
according to the CIP and applicable regulations, and has signed the Clinical Trial Agreement. 
 
The Investigator and his/her staff should have sufficient time and facilities to conduct the clinical 
investigation and should have access to an adequate number of appropriate subjects to conduct 
the clinical investigation.  
 
Source documentation (including original medical records) must be available to substantiate 
proper informed consent procedures, adherence to CIP procedures, adequate reporting and 
follow-up of adverse events, accuracy of data collected on case report forms, and device 
information.  
 
The Investigator/site will permit access to such records. A monitoring visit sign-in log will be 
maintained at the site. The Investigator will agree to dedicate an adequate amount of time to the 
monitoring process. The Investigator and/or research coordinator will be available for monitoring 
visits. It is expected that the Investigator will provide the monitor with a suitable working 
environment for review of clinical investigation-related documents. 
10.6 Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical emergencies 
when the deviation is necessary to protect the rights, safety and well-being of the subject or eliminate an 
apparent immediate hazard to the subject. In that event, the Investigator will notify Sponsor immediately 
by phone or in writing.  
 

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No waivers for CIP deviations will be granted by the Sponsor.  All deviations must be reported to the 
Sponsor using the Deviation CRF. The occurrence of CIP deviations will be monitored by the Sponsor for 
evaluation of investigator compliance to the CIP and regulatory requirements and dealt with according to 
written procedures. Investigators will inform their IRB/EC or equivalent committee of all CIP deviations in 
accordance with their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and not 
limited to):  
 Visiting the investigator and/or delegate 
 Telephoning the investigator and/or delegate 
 Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP or any other conditions of the clinical 
investigation may result in further escalation in accordance with the Sponsor’s written procedures, 
including securing compliance or, at its sole discretion, Sponsor may terminate the investigator's 
participation in the clinical investigation.  
10.7 Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical investigation records, including 
source documentation, for inspection during a Quality Assurance audit.  
 
In the event that an investigator is contacted by a Regulatory Agency in relation to this clinical 
investigation, the Investigator will notify Sponsor immediately. The Investigator and Research 
Coordinator must be available to respond to reasonable requests and audit queries made during the 
audit process. The Investigator must provide Sponsor with copies of all correspondence that may affect 
the review of the current clinical investigation (e.g., Form FDA 483, Inspectional Observations, Warning 
Letters, Inspection Reports, etc.). Sponsor may provide any needed assistance in responding to 
regulatory audits. 
10.8 Sponsor Auditing 
1. The Sponsor shall prepare an audit plan as well as the operating procedures for the related 
duties, and conduct audits in accordance with the audit plan and the operating procedures. 
2. Individual engaged in auditing (hereinafter referred to as "auditor") shall be different than those in 
charge of medical device development or monitoring. 
3. The auditor shall prepare an audit report documenting the matters confirmed in the audit to certify 
and verify that the audit has been conducted, and submit them to the Sponsor. 
10.9 Committees  
 Clinical Events Committee (CEC) 
The Clinical Events Committee (CEC) is an independent adjudication body comprised of qualified 
physicians who are not participants in the clinical investigation. The CEC will review and adjudicate pre-
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as defined in the CEC charter and according to definitions provided in this CIP. For this study, the CEC 
will review events periodically regarding their relationship to the MRI procedure. 
11.0 DATA HANDLING AND RECORD KEEPING  
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in data 
collection for the duration of the clinical investigation.  
 
CRF data collection will be performed through a secure web portal and only authorized personnel will 
access the Electronic Data Capture (EDC) system using a unique username and password to enter, 
review or correct data. Passwords and electronic signatures will be strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor. The de-identified MRI images may be transferred to the Sponsor 
using the EDC system or through a secure file transfer method.   
 
At the conclusion of the clinical investigation, completed CRF images with the date-and-time stamped 
electronic audit trail indicating the user, the data entered, and any reason for change (if applicable) will 
be provided to the investigational sites, if requested.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical investigation progress records, 
laboratory reports, CRFs, signed ICFs, device accountability records (if applicable), correspondence with 
the IRB/EC and clinical investigation monitor/Sponsor, adverse event reports, and information regarding 
subject discontinuation or completion of the clinical investigation. 
11.1 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical investigation. 
 
The Sponsor implements technical and physical access controls to ensure that Personal Information is 
accessible only to and processed only on a ‘need to know’ basis, including periodic review of access 
rights, and revocation of access when an individual’s employment is terminated or the individual 
transitions to a role that does not require access to Personal Information, and appropriate restrictions on 
physical access to premises, facilities, equipment, and records containing Personal Information. 
 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management systems only 
pseudonymous Personal Information (key-coded) necessary to conduct the Clinical Investigation, such 
as the patient’s medical condition, treatment, dates of treatment, etc. The Sponsor discloses as part of 
the clinical investigation informed consent process that some Sponsor representatives still may see 
Personal Information at the participating sites for technical support of the participating physicians on the 
device implant or procedures, monitoring and quality control purposes. Confidentiality of Personal 
Information will be observed by all parties involved at all times throughout the clinical investigation. The 
privacy of each subject and confidentiality of his/her information will be preserved in reports and when 
publishing any data. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 

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Personal Information) against unauthorized access and/or interference by third parties, intrusion, theft, 
destruction, loss or alteration. Clinical Investigation data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law 
and industry best practices. 
11.2 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, and 
issuing and resolving data discrepancies. If appropriate, the DMP may be updated throughout the 
duration of the clinical investigation. All revisions will be tracked and document controlled. 
11.3 Source Documentation  
Regulations and GCP require the Investigator to maintain information in the subject’s original medical 
records that corroborates data collected on the CRFs. In order to comply with these regulatory 
requirements/GCP, the following information should be included in the subject record at a minimum and 
if applicable to the clinical investigation: 
 
Medical history/physical condition of the subject before involvement in the clinical investigation 
sufficient to verify CIP entry criteria 
 
Dated and signed notes on the day of entry into the clinical investigation referencing the Sponsor, 
CIP number, subject ID number and a statement that informed consent was obtained 
 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 
 
Adverse events reported and their resolution, including supporting documents, such as discharge 
summaries, office notes and any other pertinent patient’s records, including documentation of site 
awareness of SAEs and of investigator assessment of device relationship for SAEs 
 
Subject’s condition upon completion of or withdrawal from the clinical investigation 
 
Any other data required to substantiate data entered into the CRF 
11.4 Case Report Form Completion  
Primary data collection based on source-documented hospital and/or clinic chart reviews will be 
performed clearly and accurately by site personnel trained on the CIP and CRF completion. The 
investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor on the CRFs and in all required reports. 
 
Data on CRFs will be collected for all subjects that are enrolled into the clinical investigation.   
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system deployed 
by the Sponsor. An electronic audit trail will be used to track any subsequent changes of the entered 
data. 
11.5 Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the clinical 
investigation as per the applicable regulatory record retention requirements. The Investigator must obtain 

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permission from Sponsor in writing before destroying or transferring control of any clinical investigation 
records. 
12.0 ETHICAL CONSIDERATION 
 
12.1 Institutional Review Board/Medical Ethics Committee Review and Approval 
Institutional Review Board (IRB) or Ethics Committee (EC) approval for the CIP and ICF/other written 
information provided to the patient will be obtained by the Principal Investigator at each investigational 
site prior to consenting and enrolling patients in this clinical investigation. The approval letter must be 
received prior to the start of this clinical investigation and a copy must be provided to the Sponsor.  
 
Any amendments to the CIP as well as associated ICF changes will be submitted to the IRB/EC and 
written approval obtained prior to implementation, according to each institution’s IRB/EC requirements.  
 
No changes will be made to the CIP or ICF or other written information provided to the patient without 
appropriate approvals, including IRB/EC, the Sponsor, and the regulatory agencies (if applicable).  
 
Until the clinical investigation is completed, the Investigator will advise his/her IRB/EC of the progress of 
this clinical investigation, per IRB/EC requirements. Written approval must be obtained from the IRB/EC 
yearly to continue the clinical investigation, or according to each institution’s IRB/EC requirements.  
 
No investigative procedures other than those defined in this CIP will be undertaken on the enrolled 
subjects without the written agreement of the IRB/EC and the Sponsor. 
13.0 CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation will be concluded when: 
 
All sites are closed AND 
 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical investigation closure. 
14.0 PUBLICATION POLICY 
The data and results from the clinical investigation are the sole property of the Sponsor. The Sponsor 
shall have the right to access and use all data and results generated during the clinical investigation. The 
Investigators will not use this clinical investigation-related data without the written consent of the Sponsor 
for any purpose other than for clinical investigation completion or for generation of publication materials, 
as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or 
presented before the multi-center results. Any proposals for publications or presentations by the 
investigators must be reviewed and approved by the Sponsor in a timely manner to enable Sponsor 
review in compliance with the Sponsor’s publication policy set forth in the Clinical Trial Agreement. 
 
The Sponsor will be responsible for determining whether to register the clinical investigation on 
www.clinicaltrials.gov or any other clinical trial registries, in accordance with the International Committee 
of Medical Journal Editors guidelines, or any other applicable guidelines. In the event Sponsor 
determines that the clinical investigation should be registered, Sponsor shall be responsible for any such 

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registration and results posting as required by the ClinicalTrials.gov website. Institution and/or Principal 
Investigator(s) shall not take any action to register the clinical investigation. 
15.0 RISK ANALYSIS 
 
15.1 Anticipated Clinical Benefits 
The primary benefit of the MR conditional neurostimulation system is that it provides subjects with the 
option to undergo an MRI procedure when clinically necessary, while defining the conditions for use that 
maximize subject safety. 
If subjects take part in this study, there may or may not be direct medical benefits to individual subjects. 
The scientific use of the data collected in this study is intended to support the CE label of the Infinity DBS 
system with MR Conditional labeling by supporting the safety of MRI procedures when performed per 
manufacturer’s requirements. 
15.2 Foreseeable Adverse Events and Anticipated Adverse Device Effects 
Risks associated with the specified device and procedure, together with their likely incidence, are 
described in the device IFU and the MRI Procedure Information Clinician’s Manual. There may be risks 
related to the device under investigation that are unknown at present. Likewise, the exact frequency of 
the risk may be unknown. 
15.3 Residual Risks Associated with the Device Under Investigation, as Identified in the 
Risk Analysis Report 
The clinical risks associated with neurostimulation systems for DBS applications are well known. Many of 
the clinical risks may develop as a consequence of not following the manufacturer recommended 
guidelines at the time of performing the MRI procedures. 
Any potential residual risks are considered to be outweighed by the benefits, and the overall residual risk 
was determined to be acceptable. Clinical evidence demonstrates acceptable safety and performance of 
the device under investigation. 
15.4 Risks Associated with Participation in this Clinical Investigation 
The risks involved with this study are comparable to those associated with the implant of any other 
commercially available MR Conditional neurostimulation system. 
15.5 Steps Taken to Control or Mitigate Risks 
The devices in use for this study are CE marked with MR Conditional labeling. In-depth 
recommendations, special precautions and instructions regarding MR Conditional procedures are 
included in the MRI Procedure Information Clinician’s Manual. Physician users are expected to be aware 
of the known and foreseeable safety risks associated with the use of the devices in an MRI environment. 
 
Risks associated with the use of the device under investigation are minimized through device design, 
investigator selection and training, pre-specified patient eligibility requirements, study monitoring to 
ensure adherence to the protocol. All adverse events will be reported to the Sponsor and will be 
monitored internally for safety surveillance purposes.  

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15.6 Risk to Benefit Rationale 
Since no design changes exist between the MR Conditional DBS system and the predicate DBS system, 
except for implementation of the MRI mode, the non-MR performance of these products is already well 
established. 
 
In addition, the clinical evidence demonstrates that the safety and performance of the device under 
investigation, when used under the conditions and for the purposes intended, as specified by the 
manufacturer, are in compliance with the Requirements of the AIMD Directive 90/385/EEC, including the 
Essential Requirements. 
 
Any undesirable side effects, under normal conditions of use, are considered to be acceptable risks 
when weighted against the performance of the device and benefits to the subject.  

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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
ABBREVIATION
TERM
ADE
Adverse Device Event
AE
Adverse Event
ASADE 
Anticipated Serious Adverse Device Event 
CA
Competent Authority
CIP 
Clinical Investigational Plan 
CRF
Case Report Form
DBS
Deep Brain Stimulation
DD 
Device Deficiency 
DMP
Data Management Plan
EC 
Ethics Committee 
ET
Essential Tremor
GCP 
Good Clinical Practice 
GP
General Practitioner
GPi
Internal Globus Pallidus
IB 
Investigator Brochure 
ICMJE
International Committee of Medical Journal Editors
ICF 
Informed Consent Form 
IFU
Instructions For Use
IPG
Implantable Pulse Generator
ISB 
Investigator Site Binder 
ISO
International Organization for Standardization
MP 
Monitoring Plan 
MRI
Magnetic Resonance Imaging
NA
Not Applicable
OPC 
Objective Performance Criteria 
PD
Parkinson’s disease
PG 
Performance Goal 
PI
Principal Investigator
PMCF
Post Market Clinical Follow UP
RDC 
Remote Data Capture 
SADE
Serious Adverse Device Event
SAE 
Serious Adverse Event 
SJM
St. Jude Medical
STN
Subthalamic nucleus
SOC 
Standard-of-care 
UCB
Upper Confidence Bound
USADE 
Unanticipated Serious Adverse Device Event 
WMA
World Medical Association
 
 
 
 
 

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APPENDIX II: DEFINITIONS 
Medical Device 
 
Any instrument, apparatus, machine, appliance, implant, software, material, or other similar or related 
article: 
 
Intended by the manufacturer to be used, alone or in combination, for human beings for one or 
more of the specific purpose(s) of 
o Diagnosis, prevention, monitoring, treatments or alleviation of disease 
o Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury 
o Investigation, replacement, modification, or support of the anatomy of a physiological 
process 
o Supporting or sustaining life 
o Control of conception 
o Disinfection of medical devices and 
 
Which does not achieve its primary intended action in or on the human body by pharmacological, 
immunological, or metabolic means, but which may be assisted in its intended function by such 
means 
 
Device Deficiency/Device Malfunction 
 
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate 
labeling. This includes the failure of the device to meet its performance specifications or otherwise 
perform as intended. Note: Performance specifications include all claims made in the labeling of the 
device. 
 
A device malfunction is the failure of a device to meet its performance specifications or otherwise 
perform as intended, when used in accordance with the instructions for use or CIP. 
 
 

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APPENDIX III: SITE CONTACT INFORMATION 
Contact information for each participating clinical site is available under separate cover by 
contacting the Sponsor at: 
 
Abbott 
The Corporate Village 
Da Vincilaan 11, Box F1 
1935 Zaventem Belgium 
Email: monique.vanbree@abbott.com 
Phone: +32 2 774 69 47 
 
 

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APPENDIX IV: REFERENCES 
1. 
Anderson VC, Burchiel KJ, Hogarth P, Favre J, Hammerstad JP. Pallidal vs subthalamic nucleus 
deep brain stimulation in Parkinson disease. Arch Neurol. 2005;62(4):554-560. 
2. 
Benabid AL, Chabardes S, Mitrofanis J, Pollak P. Deep brain stimulation of the subthalamic 
nucleus for the treatment of Parkinson's disease. Lancet Neurol. 2009;8(1):67-81. 
3. 
Bonenfant J, Drapier S, Houvenaghel JF, et al. Pallidal stimulation in Parkinson's patients with 
contraindications to subthalamic target: A 3 years follow-up. Parkinsonism Relat Disord. 
2017;34:20-25. 
4. 
Deep-Brain Stimulation for Parkinson's Disease Study G, Obeso JA, Olanow CW, et al. Deep-
brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in 
Parkinson's disease. N Engl J Med. 2001;345(13):956-963. 
5. 
Follett KA, Weaver FM, Stern M, et al. Pallidal versus subthalamic deep-brain stimulation for 
Parkinson's disease. N Engl J Med. 2010;362(22):2077-2091. 
6. 
Krack P, Batir A, Van Blercom N, et al. Five-year follow-up of bilateral stimulation of the 
subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 2003;349(20):1925-1934. 
7. 
Benabid AL, Pollak P, Gao D, et al. Chronic electrical stimulation of the ventralis intermedius 
nucleus of the thalamus as a treatment of movement disorders. J Neurosurg. 1996;84(2):203-
214. 
8. 
Cheung T, Noecker AM, Alterman RL, McIntyre CC, Tagliati M. Defining a therapeutic target for 
pallidal deep brain stimulation for dystonia. Ann Neurol. 2014;76(1):22-30. 
9. 
Perlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-257. 
10. 
Schwalb JM, Hamani C. The history and future of deep brain stimulation. Neurotherapeutics. 
2008;5(1):3-13. 
11. 
Deuschl G, Schade-Brittinger C, Krack P, et al. A randomized trial of deep-brain stimulation for 
Parkinson's disease. N Engl J Med. 2006;355(9):896-908. 
12. 
Moro E, Lozano AM, Pollak P, et al. Long-term results of a multicenter study on subthalamic and 
pallidal stimulation in Parkinson's disease. Mov Disord. 2010;25(5):578-586. 
13. 
Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2012;367(16):1529-
1538. 
14. 
Okun MS, Gallo BV, Mandybur G, et al. Subthalamic deep brain stimulation with a constant-
current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol. 
2012;11(2):140-149. 
15. 
Sharan A, Rezai AR, Nyenhuis JA, et al. MR safety in patients with implanted deep brain 
stimulation systems (DBS). Acta Neurochir Suppl. 2003;87:141-145. 
16. 
Dormont D, Seidenwurm D, Galanaud D, Cornu P, Yelnik J, Bardinet E. Neuroimaging and deep 
brain stimulation. AJNR Am J Neuroradiol. 2010;31(1):15-23. 
17. 
Larson PS, Richardson RM, Starr PA, Martin AJ. Magnetic resonance imaging of implanted deep 
brain stimulators: experience in a large series. Stereotact Funct Neurosurg. 2008;86(2):92-100. 
 
 

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APPENDIX V: CASE REPORT FORMS 
 
 
 

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APPENDIX VI: INFORMED CONSENT FORM 
 
 
 

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APPENDIX VII: MONITORING PLAN 
 
 
 
 

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APPENDIX IX: LABELING 
 
 
 
 

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APPENDIX X: CIP SUMMARY 
Clinical 
Investigation 
Name and 
Number
CRD_950 Infinity MRI PMCF 
Title 
A Post-Market Study Evaluating the Safety of Infinity DBS System with MR 
Conditional Labeling
Objective(s) 
The primary objective of the Infinity MRI PMCF is to support the safety of the 
Infinity DBS System with MR Conditional labeling.
Device Under 
Investigation 
The following devices will be used in the study: 
Infinity DBS System  
 
Infinity IPGs used with 8 channel leads (Models 6660, 6662) 
 
Infinity Clinician Programmer App and Patient Controller App (Models 
3874, 3875) 
 
The following components may be implanted in subjects with “lead-only” 
configuration: 
Leads: 
 
6170 St. Jude Medical Infinity DBS System Directional lead, 30 cm, 0.5 
mm spacing 
 
6171 St. Jude Medical Infinity DBS System Directional lead, 30 cm, 1.5 
mm spacing 
 
6172 St. Jude Medical Infinity DBS System Directional lead, 40 cm, 0.5 
mm spacing 
 
6173 St. Jude Medical Infinity DBS System Directional lead, 40 cm, 1.5 
mm spacing 
Lead protection boot (included in lead kit) 
6010 Guardian cranial burr hole cover system (optional) 
6015 Screw, 5mm (optional) 
The following components may be implanted in subjects with “full-system” 
configuration: 
IPG (implanted in pectoral or abdominal area): 
 
6660 St. Jude Medical Infinity DBS IPG 5.3 Ah 
 
6662 St. Jude Medical Infinity DBS IPG 7.5 Ah 
Leads: 
 
6170 St. Jude Medical Infinity DBS System Directional lead, 30 cm, 0.5 
mm spacing 
 
6171 St. Jude Medical Infinity DBS System Directional lead, 30 cm, 1.5 
mm spacing 
 
6172 St. Jude Medical Infinity DBS System Directional lead, 40 cm, 0.5 
mm spacing 
 
6173 St. Jude Medical Infinity DBS System Directional lead, 40 cm, 1.5 
mm spacing

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Extensions: 
 
6371 St. Jude Medical Infinity DBS System 8CH Flex Extn, 50 cm 
 
6372 St. Jude Medical Infinity DBS System 8CH Flex Extn, 60 cm 
6010 Guardian cranial burr hole cover system (optional) 
6015 Screw, 5mm (optional) 
Number of 
Subjects Required 
for Inclusion in 
Clinical 
Investigation
The study will be conducted at centers that are qualified to participate and will 
enroll up to 74 subjects at up to 25 centers in geographies where Infinity DBS 
systems with MR Conditional labeling are approved including the European 
Union and the United States.   
Clinical 
Investigation 
Design 
This study will be conducted as an international, multicenter, observational, 
prospective, single-arm, post-market clinical follow-up (PMCF). The study will 
evaluate the MRI safety of the Infinity DBS system with MR Conditional labeling 
when used according to the approved guidance.
Primary Endpoint
The primary endpoint is the rate of MRI-related adverse events. 
Secondary 
Endpoints  
The following secondary endpoints are for subjects undergoing an MRI 
procedure with the full system configuration. 
 
Rate of successful MRI mode ‘turn on/off’ functionality of the MRI mode 
 
Rate of successful ‘turn on/off’ functionality for the stimulation 
 
Rate of successful adjustments to the stimulation amplitude 
 
Rate of successful interrogation and download of the IPG parameters 
 
Rate of successful ability to obtain lead impedance measurements  
Additional Safety 
Endpoint
Characterization of all MRI-related adverse events. 
Subject Follow-up 
 
Enrollment/Baseline (in clinic) 
 
MRI Procedure Visit (in clinic) 

1 month post-MRI procedure (in clinic)
Inclusion Criteria 
 
Subject or subject’s legally acceptable representative must provide written 
informed consent prior to any clinical investigation related procedure. 
 
Subject has been implanted, or is scheduled to be implanted, with a 
commercially available Infinity DBS system with MR Conditional labeling 
per locally approved indications for use. 
 
Subject is scheduled to undergo a MRI procedure in compliance with the 
MRI Procedure Information Clinician’s manual. Anxiolytics and patient’s 
regular medications may be administered, provided IFU criteria are met. 
 
Subject is willing and able to comply with study requirements. 

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Exclusion Criteria 
 
Subject has another implanted device (active or passive implanted device) 
that prohibits safe scanning. 
 
Subject has previously experienced an MRI-related adverse event or cannot 
undergo MRI for any other reason. 
 
Subject is pregnant or nursing, or plans to become pregnant during the 
clinical investigation follow-up period.  
 
Subject has other anatomic or comorbid conditions, or other medical, social, 
or psychological conditions that, in the investigator’s opinion, could limit the 
subject’s ability to participate in the clinical investigation or to comply with 
follow-up requirements, or impact the scientific soundness of the clinical 
investigation results. 
 
Subject is currently participating in another clinical investigation that may 
confound the results of this study.