Medtronic Signia Small Diameter Reload Product Surveillance Registry
Conditions: Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
Sponsor: Medtronic

Surgical 
Product Surveillance Registry Platform Base Clinical Investigation Plan 
Version 3 25Feb2025 
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Medtronic 
Clinical Investigation Plan 
Clinical Investigation Plan (CIP) 
Surgical 
PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE 
Sponsor/Local Sponsor 
Medtronic, Inc. 
Operational Headquarters 
710 Medtronic Parkway 
Fridley, MN 55432 
Note: Other geographies and/or locations are included under a 
separate cover. 
Document Version 
Version 3, 25 Feb 2025 
Comprised of: 
PSR Core Version 9, 19 May 2020 
Surgical Appendix Version 3, 25 Feb 2025 
Note: A record of CIP approvers is maintained under a separate 
cover and can be requested if required per local regulations. 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic 
Inc., and its subsidiary and affiliated entities. Any distribution, copying, or disclosure without the prior 
written authorization of Medtronic is strictly prohibited. Persons to whom the information is disclosed 
must know that it is confidential and that it may not be further disclosed by them. 
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1. Investigator Statement 
Clinical Investigation Plan (CIP) 
Surgical 
PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE 
Document Version 
Version 3, 25 Feb 2025 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this registry as described. I will conduct this registry as outlined herein. 
I agree to comply with Federal Regulations (21 CFR Part 11, 50 and 56), the International Standard 
(ISO) 14155, and applicable regional/local regulations. I agree to ensure that the confidential 
information contained in this document will not be used for any purpose other than the evaluation 
and conduct of the registry without the prior written consent of Medtronic. 
I will provide all registry personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the registry. 
Investigator's Signature: 
Investigator's Name: 
Institution: 
Date: 
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Table of Contents 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
2. 
Glossary .............................................................................................................................. 6 
3. 
Synopsis ............................................................................................................................. 8 
4. 
Introduction ..................................................................................................................... 10 
4.1. Background ..................................... ..... ................................................................................. 10 
4.2. Purpose ................................................................................................................................. 10 
4.3. Eligible Products .................................................................................................................... 11 
5. 
Objectives ........................................................................................................................ 11 
5.1. Objectives ............................................................................................................................. 11 
6. 
Design .............................................................................................................................. 12 
6.1. General ................................................................................................................................. 12 
6.2. Analysis Requirements ........................................................................................................... 13 
6.3. Steps Taken to Minimize Bias .................................................................................................. 14 
6.4. Duration ................................................................................................................................ 15 
6.5. Rationale ............................................................................................................................... 15 
7. 
Product Description .......................................................................................................... 15 
7 .1. General ................................................................................................................................. 15 
8. 
Selection of Subjects ........................................................................................................ 15 
8.1. Registry Population ................................................................................................................ 15 
8.2. Subject Enrollment ................................ ...................... ................................................. ..... ..... 15 
8.3. Inclusion Criteria ..... ...... ............. .................................................... ................................... ..... 16 
8.4. Exclusion Criteria ....................... ............................................................................................ 16 
9. 
Site Selection and Readiness ........................................................................................... 16 
9.1. Site Selection ......................................................................................................................... 16 
9.2. Site Readiness ................................. ................................. ........................................... .......... 17 
9.3. Training ................... ..... ............. .................................................... ...... ........................ .......... 18 
10. Registry Procedures ......................................................................................................... 18 
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10.1 Clinical Data Collection and Procedure Descriptions .................................................................. 18 
10.2 Schedule of Events ................................................................................................................. 18 
10.3 Informed Consent .................................................................................................................. 19 
10.4 Baseline ................................................................................................................................ 21 
10.5 Procedures ............................................................................................................................ 21 
10.6 Follow-up .............................................................................................................................. 21 
10.6.1 
Frequency of Follow-up ............... ............................ .................. ...... .................................. 21 
10.6.2 
Modes of Data Collection .................................................................................................. 21 
10.6.3 
Follow-up Duration ......................................................................... .................................. 22 
10.6.4 
Lost to Follow-up .............................................................................................................. 22 
10 .7 System Modification/Retreatment ............................................................................................ 22 
10.8 Patient Death ........... .................................................... ........................................................ .. 22 
10.9 Assessment of Safety ............................................................................................................. 23 
10.10 
Recording Data ................................................................................................................ 23 
10.11 
Deviation Handling ......................................................................................................... .. 23 
10.12 
Subject Exit, Withdrawal or Discontinuation ....................................................................... 24 
11. Risks and Benefits ............................................................................................................ 25 
12. Adverse Events and Device Deficiencies .......................................................................... 25 
12 .1. 
Definitions/Classifications .................................................................................................. 25 
12.2. 
Reporting of Adverse Events & Device Deficiencies ........ ........................ ............................. 27 
13. Data Review Committees ................................................................................................. 28 
14. Statistical Design and Methods ........................................................................................ 29 
15. Ethics ................................................................................................................................ 29 
15.1. 
Statement(s) of Compliance .............................................................................................. 29 
16. Study Administration ....................................................................................................... 30 
16.1. 
Monitoring ....................................................................................................................... 30 
16.2. 
Data Management ............................................................................................................ 30 
16.3. 
Direct Access to Source Data/Documents ................ ................... ........... ............. ................ 31 
16.4. 
Confidentiality .................................................................................................................. 31 
16.5. 
Liability ............................................................................................................................ 31 
16.6. 
CIP Amendments .............................................................................................................. 32 
16. 7. 
Record Retention .............................................................................................................. 32 
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16.7.1 
Site Records ....................................................................................................................... 32 
16. 7.2 
Medtronic Records ............................................................................................................ 32 
16.8. 
Reporting Requirements .............................................. ........................ ................... .......... 33 
16.8.1. 
16.8.2. 
Site Reports ........................................................................................................................ 33 
Medtronic Reports ............................................................................................................. 34 
16.9. 
Publication and Use of Information ............................... ........................ ................... .......... 35 
16.9.1. 
16.9.2. 
Publication Committees .................................................................................................... 35 
Criteria for Determining Authorship .................................................................................. 36 
16.9.3. Publication Requests ......................................................................................................... 36 
16.9.4. Publication of Results ........................................................................................................ 37 
16.10. 
Suspension or Early Termination ................................... ........................................... .......... 37 
16.10.1. 
Criteria for Suspension or Early Termination ..................................................................... 37 
17. 
References ............................................................................................................ 38 
18. 
Appendices ............................................................................................................ 38 
19. 
Version History ...................................................................................................... 38 
Table of Figures 
Figure 1: PSR Platform Base CIP Modular Design ...................................................................................... 13 
Figure 2: Decision tree for use of AP or AD in the PSR ............................................................................... 14 
Table of Tables 
Table 1: Example of Data Collection Requirements .................................................................................. 18 
Table 2: Adverse Event and Device Deficiency Definitions ........................................................................ 25 
Table 3: Site Reports .................................................................................................................................. 33 
Table 4: Medtronic Reports ....................................................................................................................... 35 
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2. Glossary 
Acronym 
Term 
AD 
Addendum 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Analysis Plan 
CEC 
Clinical Event Committee 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
DD 
Device Deficiency 
DRF 
Data Release Form 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
FD 
Financial Disclosure 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HREC 
Human Research Ethics Committee 
IC 
Informed Consent 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
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Acronym 
Term 
LAR 
Legally Authorized Representative 
MEC 
Medical Ethics Committee 
Pl 
Principal Investigator 
PSR 
Product Surveillance Registry 
RA 
Regulatory Authority 
SADE 
Serious Adverse Device Effect 
REB 
Research Ethics Board 
SAE 
Serious Adverse Event 
us 
United States of America 
USADE 
Unanticipated Serious Adverse Device Effect 
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3. Synopsis 
Clinical Study Type 
Post-Market Registry 
Product Status 
Medtronic market released products 
Instructions for Use (IFU) and/or product labelling provided in their 
respective manuals 
Sponsor 
Medtronic, Inc. 
Operational Headquarters 
710 Medtronic Parkway 
Fridley, MN U.S.A. 55432 
1-800-633-8766 
Note: Medtronic, Inc. is the funding source for the Product 
Surveillance Registry 
Local Sponsor 
All Medtronic geographies and/or locations are listed under a 
separate cover 
External Organizations 
External organizations involved in the clinical investigation, if 
applicable, will be listed under a separate cover 
Purpose/Overview 
• 
Provide continuing evaluation and periodic reporting of safety 
and effectiveness of Medtronic market-released products for 
their intended use 
• 
Obtain real-world performance and safety information from a 
global network of hospitals, clinics, and clinicians intended to 
represent the range of clinical environments in which Medtronic 
products are used 
• 
Support post-market surveillance activities and post-approval 
studies that are initiated by Medtronic, regulated by local 
governments, or are conducted to fulfill government and/or 
regulatory authority requests 
• 
Obtain clinical evidence to guide the development and 
improvement of medical devices, therapies, device guidelines, 
and patient services/solutions 
• 
Provide clinical data to support health economics and clinical 
outcomes research 
Objectives 
Serve as an ongoing source of product performance, patient safety 
and clinical outcomes information associated with the use of market-
released products. Objectives include: 
• 
To identify device failures, adverse events or adverse eventtrends 
• 
To characterize patient outcomes 
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• 
To characterize patterns of product use 
• 
To characterize predictors of performance and effectiveness 
• 
To identify potential signals for emerging performance issues 
Study Design 
Patient-centric, active post-market registry 
with an extensible design allowing products to be added following 
market release. Patients are enrolled and followed in accordance 
with the routine care practices of their care provider. 
Eligibility Criteria 
Inclusion Criteria: 
• 
Patient or legally authorized representative (LAR) provides 
authorization and/or consent per institution and geographical 
requirements 
• 
Patient has or is intended to receive or be treated with an eligible 
Medtronic product 
• 
Patient is consented within the enrollment window of the therapy 
received, as applicable 
Exclusion Criteria: 
• 
Patient who is, or is expected to be, inaccessible for follow-up 
• 
Participation is excluded by local law 
• 
Patient is currently enrolled or plans to enroll in concurrent 
drug/device study that may confound the PSR results 
Note: Additional criteria may be required, refer to Condition/ Therapy 
Appendix for further guidance. 
Study Procedures and 
Medtronic products are used to monitor, diagnose and/ or treat many 
Assessments 
medical conditions. The PSR is an observational registry intended to 
collect data consistent with routine clinical care practices. In general, 
data collection includes: 
• 
Demographics 
• 
Medical History 
• 
Procedure Information 
• 
Patient Status 
• 
Adverse Events 
• 
Outcome Measures 
• 
Device Deficiencies 
In-person follow-up frequency is intended to align with routine 
clinical care practices consistent with real-world data collection. 
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However, in real-world clinical settings, routine care practices may 
vary for several reasons including but not limited to: physician 
preference, a patient's condition and/or personal circumstances; 
therefore, to mitigate potential bias and ensure a robust data set, 
sites are required to report patient status at regular intervals 
regardless of whether the patients are seen in-person. 
Events are reported upon a site's first awareness throughout a 
patient's participation. Reportable events include: 
• 
Device-Related Events 
• 
Procedure-Related Events 
• 
Therapy-Relevant Events1 
Note1: Additional therapy-specific details may be provided in the Condition/Therapy Appendix. 
4. Introduction 
4.1. Background 
Medtronic's commitment to quality is exemplified in our mission, "To strive without reserve for the 
greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison 
and to be recognized as a company of dedication, honesty, integrity, and service." Consistent with this 
commitment, Medtronic has continually worked to develop systems and processes to more effectively 
monitor product performance following market release. Medtronic launched the global Product 
Surveillance Registry (PSR) in 2011, which was built on more than 25 years of post-market clinical 
surveillance experience to create a comprehensive product registry. 
The PSR is sponsored by Medtronic and is comprised of a global network of hospitals, clinics and 
clinicians from which reliable real-world product safety and patient clinical outcome information is 
generated. It leverages a common infrastructure designed for the collection, analysis and dissemination 
of surveillance information for multiple Medtronic device technologies. 
4.2. Purpose 
The purpose of the PSR is to provide continuing evaluation and periodic reporting of safety and 
effectiveness of market-released products for their intended use. PSR data will support post-market 
surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local 
governments, or are conducted to fulfill government and/ or regulatory authority requests. The PSR will 
also obtain clinical evidence to guide the development and improvement of medical devices, therapies, 
device guidelines, patient services/solutions and provide clinical data to support health economics and 
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clinical outcomes research. Conducting product surveillance in populations over time provides an 
effective means of assessing product performance, patient safety and clinical outcomes. Product 
surveillance is the systematic collection, analysis, and interpretation of performance data, as well as its 
dissemination and application. 
The PSR is designed to provide a repository of data for conducting signal detection activities for 
identification of emerging patient safety or performance issues. It is designed to obtain real-world 
performance and safety information from a global network of hospitals, clinics, and clinicians intended 
to represent the range of clinical environments in which Medtronic products are used. It provides a 
mechanism for gaining an increased understanding of the relationship between a product's 
performance and clinical outcomes, as well as improving patient safety by identifying potential 
performance trends. 
The PSR data are intended to benefit and support interests of patients, hospitals, clinicians, regulatory 
bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge 
performance assessment via the least burdensome approach. 
4.3. Eligible Products 
Eligible products include market-released products. Approved indications of use for each market-
released product are defined in the Instructions for Use (I FU) and/or product labelling. Not all 
Medtronic market-released products are eligible for enrollment. Product eligibility is based on the 
determination that there is an interest or requirement for obtaining additional information to further 
characterize product performance following market release. Medtronic may limit enrollment using an 
Enrollment Guide typically when the number enrolled is adequate to effectively assess product 
performance or product availability is restricted. 
5. Objectives 
5 .1. Objectives 
Conducting active post-market surveillance is dynamic. Therefore, the PSR is designed to adapt as 
technology, information, and/or requirements change with the capability of aggregating multiple 
surveillance data sources, providing increased value and utility in terms of product performance 
assessment. The objective of the PSR is to serve as an ongoing source of product performance, patient 
safety and clinical outcomes information associated with the use of market-released products. 
Objectives include: 
• 
To identify device failures, adverse events or adverse event trends 
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• 
To characterize patient outcomes 
• 
To characterize patterns of product use 
• 
To characterize predictors of performance and effectiveness 
• 
To identify potential signals for emerging performance issues 
6. Design 
6.1. General 
The PSR is designed to conduct active post-market surveillance. The PSR has an extensible design 
allowing products to be easily added following market release. Only patients treated with an eligible 
product can be enrolled, refer to Section 4.3. Data collection is intended to align with routine clinical 
care practice. 
The PSR is patient-centric, following patients receiving one or more therpaies over their continuum of 
clinical care. Sites may participate and contribute to the surveillance of multiple therapies. Sites are not 
required to participate in all PSR-supported conditions and/or therapies. 
The PSR Platform Base CIP format has a modular design which provides a framework for the collection 
of surveillance data to support Medtronic's product portfolio. The PSR Platform Base CIP for a given 
Condition/Therapy is comprised of the following: 
• 
PSR Core: defines elements applicable to all PSR patients, products, conditions, or therapies 
• 
PSR Condition/Therapy Appendix: expands on the content of the PSR Core to further define 
specific procedure and data collection requirements for a given Condition/Therapy and is 
intended to align with routine care practices 
The PSR Platform Base CIP is referred to as "CIP" throughout this document. The CIP for a given 
Condition/Therapy defines all minimum patient and site participation requirements (Refer to Figure 1). 
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Figure 1: PSR Platform Base CIP Modular Design 
PSRCore 
All PSR patients 
regardless of 
Condition& 
Therapy 
+ 
+ 
+ 
+ 
PSR Condition/ 
Therapy Appendix 
Condit ion/Therapy 1 
Condition/Therapy 2 
Condition/Therapy 3 
Condition/Therapy 4 
6.2. Analysis Requirements 
PSR Platform BaN CIP 
-
PSR Platform Base CIP -
-
Condit ion/Therapy 1 
-
PSR Platform Base CIP -
-
Condition/Therapy 2 
-
PSR Platform Base CIP -
-
Condition/Therapy 3 
-
PSR Platform Base CIP -
-
Condition/Therapy 4 
Specific analysis requirements are documented, as applicable, and are integrated with the CIP in one of 
two ways, either via an associated Analysis Plan (AP) or Addendum (AD). Refer to the decision process 
provided in (Figure 2). 
An AP, at a minimum, specifies the intended sample size estimates, analysis time points, reporting, etc. 
for a sub-population (and their data) from the overall PSR cohort of a given Condition/Therapy. The AP 
document can be specific to a patient population, therapy, product or product group and defines how 
the data will be analyzed. It does not contain any procedures or data collection requirements that differ 
from the CIP; therefore, an AP has no impact on the patient or how the site conducts PSR activities. 
An AD can be specific to a patient population, therapy, product or product group, but unlike the AP, it 
does contain procedure and/or data collection elements that differ from the CIP. The AD describes the 
specific procedures that differ from the CIP (e.g., regulatory directed requirement), therefore an AD may 
impact the patient and/or how the site conducts PSR activities. An AD may have IRB/ Ethics Board, 
consent and potentially regulatory implications; therefore, additional site readiness activities may be 
needed, refer to Section 9.2. An AD includes, but is not limited to, unique procedure requirements, 
objectives/endpoints, statistical methodology, analysis cohort, and reporting timelines. 
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Figure 2: Decision tree for use of AP or AD 
PSRCore 
Condit ion/Therapy 
Appendix 
No 
PSR Platform 
Condition/Therapy 
Base CIP 
(Defines al patient and site 
participation requirementst 
Does the Base CIP 
include all elements 
required to meet project 
objective(s)* ? 
Yes 
Addendum (AD) 
Analysis Plan (AP) 
*Extensib le Design: Supports Multiple Analysis 
Plans and/or Addend urns 
6.3. Steps Taken to Minimize Bias 
Sites must meet pre-defined criteria to be selected to participate in the registry. The following methods 
may be incorporated to further minimize potential bias: 
• 
Sites will consider enrollment of all eligible patients 
• 
Enrollment may be limited at a site level by product and/or by therapy 
• 
Events may be adjudicated by an independent review committee, as determined by therapy or 
regulatory requirements 
• 
Diverse geographical site representation 
• 
Sites represent various types of practice settings including university, community, public and 
private 
• 
Data may be assessed by an independent reviewer (e.g., Core lab) as determined by therapy 
• 
Procedures and data collection requirements are st andardized 
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In addition, confounding variables and factors will be taken into consideration during data analysis, as 
applicable. Confounding variables and factors may include, but are not limited to: 
• 
Medical history (e.g., comorbidities, surgical history) 
• 
Patient-related factors (e.g., age, sex) 
• 
Concomitant therapies 
6.4. Duration 
The duration of the registry may vary per Condition/Therapy and has no anticipated overall end date. 
6.5. Rationale 
The PSR is designed to conduct active post-market surveillance in populations over time providing an 
effective means of assessing product performance, patient safety and clinical outcomes. The PSR has an 
extensible design allowing products to be added on an on-going basis. 
7. Product Description 
7.1. General 
Eligible products include Medtronic market-released products. Not all Medtronic market-released 
products are enrolled into the PSR. Product eligibility is based on the determination that there is an 
interest or requirement for obtaining additional information to further characterize product 
performance following market release. 
8. Selection of Subjects 
8.1. Registry Population 
Patients are treated with an eligible Medtronic market-released product. The PSR supports active post 
market surveillance of multiple products used in the clinical care of numerous patient conditions for 
which Medtronic offers treatment. 
8.2. Subject Enrollment 
Enrollment of a patient is complete once the Informed Consent Form (ICF) or the Data Release Form 
(ORF) and an Authorization, if applicable, have been obtained. The following data will be collected at 
Enrollment: 
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• 
Consent (ORF or ICF) signature and date 
If consent is waived, or is not required by local regulations, refer to the Condition/Therapy Appendix for 
patient enrollment information. 
Patients are to be enrolled within an enrollment window defined by the therapy received. Refer to the 
Condition/Therapy Appendix for specific enrollment criteria. It is the site's responsibility to maintain a 
log of all patients enrolled in the registry. A consent/enrollment tracking tool may be provided to sites 
to assist in tracking the attempts to enroll eligible patients. 
Retrospective patient enrollment may be allowed in certain instances. Refer to the Condition/Therapy 
Appendix for more enrollment details, if applicable. 
8.3. Inclusion Criteria 
• 
Patient or legally authorized representative ( LAR) provides authorization and/or consent per 
institution and geographical requirements 
• 
Patient has, or is intended to receive or be treated with, an eligible Medtronic product (Section 
4.3) 
• 
Patient is consented within the enrollment window of the therapy received, as applicable 
Additional criteria may be required, refer to Condition/Therapy Appendix for further guidance. 
8.4. Exclusion Criteria 
• 
Patient who is, or is expected to be, inaccessible for follow-up 
• 
Patient is excluded by local law 
• 
Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may 
confound the PSR results (i.e. no required intervention that could affect interpretation of all-
around product safety and/or effectiveness) 
Additional criteria may be required, refer to Condition/Therapy Appendix for further guidance. 
9. Site Selection and Readiness 
9.1. Site Selection 
Sites participating in the PSR are located globally. At a minimum, the following criteria will be met 
before sites are selected for participation: 
• 
Site clinicians are or will be users of Medtronic products 
• 
Site has strong interest in active post-market surveillance 
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• 
Site has adequate resources, facilities, equipment and support staff 
• 
Site can comply with registry requirements, local laws or regulations, and Medtronic 
requirements 
• 
Sites are responsible for ensuring practicing clinicians are appropriately licensed/qualified 
• 
Sites are responsible to ensure practicing clinicians are not debarred, disqualified, or working 
under sanctions in applicable regions 
• 
Pl qualifications confirmed 
The role of the principal investigator (Pl) is to implement and manage the day-to-day conduct of the 
registry as well as ensure data integrity and the rights, safety and well-being of the patients involved in 
the registry. The Pl shall be qualified by education, training and experience to assume responsibility for 
the proper conduct of the clinical registry in accordance with the CIP and applicable local regulations. 
9.2. Site Readiness 
Prior to enrolling any patients into the PSR, sites must fulfill all local law, regulatory and sponsor 
requirements. The term Ethics Board will be used to define Institutional Review Board (IRB), Medical 
Ethics Committee (MEC), Research Ethics Board (REB), or Human Research Ethics committee (HREC). 
Participation readiness includes but is not limited to: 
• 
Ethics Board approval or a written statement by the Ethics Board Chairperson or Pl stating that 
approval is not required or documentation that approval is not required per local law 
• 
Documented Ethics Board and sponsor approval of the ICF or DRF (if required), CIP and 
associated Addendums (as applicable) 
• 
A legally executed Clinical Trial Agreement (CTA) 
• 
Insurance certificates (as required per geography) 
• 
Regulatory authority notification/approval, if required 
• 
Documented training 
Sites are authorized to enroll patients in accordance with the CIP. A list of sites, including Pl and 
institutions, participating in the registry is available under a separate cover. 
Medtronic will provide PSR participating sites with applicable registry materials (e.g., site binder). Note: 
If an AD (Refer to Section 6.2) is required, additional site readiness activities specific to the AD may be 
required. 
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9.3. Training 
Training includes an overview of, but not limited to, registry objectives, purpose, consent process, 
design, data collection, reporting and applicable regulations. 
Any registry personnel assisting with execution of PSR-related tasks will require CIP training on the 
activities pertinent to their involvement. Training will be documented. Additional meetings or 
conference calls may be scheduled to address ongoing site training. Following appropriate training, 
delegation of tasks will be documented. 
10. Registry Procedures 
10.1 Clinical Data Collection and Procedure Descriptions 
Medtronic products may be used to monitor, diagnose and/or treat many medical conditions, therefore 
the following sections provide a general summary of the type of information gathered and procedures 
applicable for all PSR enrolled patients regardless of their condition, procedure, and therapy received 
(Refer to Table 1 for an example). 
The PSR is an observational registry intended to collect data consistent with routine clinical care 
practices. Real-world clinical practice routines are not consistent across sites (i.e., physician preference, 
patient's condition and/or personal circumstances); therefore, to mitigate potential bias and ensure a 
robust data set, patient status is required to be reported at regular intervals regardless of whether the 
patients are seen in-person. Refer to the Condition/Therapy Appendix for more detailed data 
collection and procedure requirements for a particular patient condition and therapy. 
Data collection is intended to reflect routine clinical care procedures and may include prospective and 
retrospective data. Data collection details and CRFs (where required) are provided under separate cover. 
10.2 Schedule of Events 
Table 1: Example of Data Collection Requirements 
Enrollment 
Baseline 
Procedure (*) 
Follow-up 
Exit 
ICF or DRF Signed 
and Dated 
X 
Demographics 
X 
Outcome measures 
X 
X 
X 
(if applicable) 
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Enrollment 
Baseline 
Procedure (*) 
Follow-up 
Exit 
Medical History 
X 
Device/System 
X 
Information 
X 
(if applicable) 
Procedure 
X 
Details(*) 
Patient 
X 
X 
X 
Status/Treatments 
X 
System 
Modification/ 
Upon Site's First Awareness 
Retreatment 
Adverse Events 
Upon Site's First Awareness 
Device Deficiencies 
Upon Site's First Awareness 
Deaths 
Upon Site's First Awareness 
CIP Deviations 
Upon Site's First Awareness 
(*): Treatment initiation for those products which do not have a procedure 
10.3 Informed Consent 
Informed consent is defined as legally effective, documented confirmation of a patient's (or their LAR, 
legal representative, or guardian) voluntary agreement to participate in the PSR. Data Release Forms 
may also be utilized for the PSR since the PSR is focused on collecting real-world data available through 
medical records. 
Patient consent will be obtained in accordance with local law and regulations. The ICF or DRF is signed 
only after all relevant information regarding participation has been provided to the patient. Consent 
must be obtained by Pl or authorized designee. The ICF or DRF is applicable to all PSR patients as 
required. The ICF or DRF must include all information relevant to the patient's decision to participate. 
The ICF or DRF, and any applicable authorizations, must be approved by the sponsor and the site's Ethics 
Board unless an Ethics Board waiver for consent is obtained. The ICF or DRF documents must be 
maintained in such a way as to assure control of the document (i.e. version and/or date) such that the 
version(s) approved by the Ethics Board are clear with a documented change history for all revisions. 
The process for obtaining informed consent shall: 
• 
Avoid any coercion of, or undue/improper influence of patients to participate 
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• 
Not waive or appear to waive patient's legal rights 
• 
Provide documents to the patient in a language she/he can read and understand 
• 
Use language that is non-technical and understandable to the patient or legal representative 
• 
Provide ample time for the patient to read and understand the ICF/DRF in order to consider 
participation 
• 
Include a dated signature by the patient or legal representative acknowledging that their 
participation in the PSR is voluntary 
• 
Include a dated signature by the responsible Pl or authorized designee (if required by local law). 
If the patient can't read or write, or is not able to fully understand all aspects of the registry, a witnessed 
and supervised (impartial third party) oral patient information consent is allowed as long as detailed 
documentation of the process is recorded in the patient's case history and the witness signs and dates 
the patient ICF or DRF on behalf of the patient. The ICF/DRF and any other information should be read 
aloud and explained within his/her ability to understand. Whenever possible, the patient/LAR shall sign 
("make his mark", sign or otherwise physically mark the document to indicated consent) on the ICF/DRF. 
The impartial witness shall sign and personally date the ICF/DRF and Authorization (as determined by 
local law) to attest that the information was accurately explained, and consent was freely given. 
Vulnerable patients are individuals who are unable to fully understand all aspects of the registry that are 
relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a 
compromised position, expectation of benefits or fear of retaliatory response. Examples of vulnerable 
patients may include a(n) infant, child and juvenile, seriously ill or unconscious patients, or patients with 
a mental or intellectual disability. Special consideration is required for vulnerable patients when 
considered for PSR participation. Patients who are considered "vulnerable" are to be consented 
according to the relevant local laws and regulations of the country in which they are located, as well as 
any other institutional requirements that apply, including those specified by the Ethics Board. 
Unless waived by the Ethics Board, the signed ICF or DRF and the authorization (as determined by local 
law) must be filed at the site. A signed and dated copy of the ICF or DRF and any other authorizations, 
must be provided to the patient. The original signed ICF or DRF and the authorization (if required) or 
other privacy language where required by law, must be retained and made available for review by 
sponsor site monitors, auditors, or regulatory inspectors. 
The consent process should be documented at each site, at minimum, with a progress note in the 
patient's case history. The consent process should ensure important new information is provided to 
patients throughout the registry, which may relate to the patient's willingness to continue participation 
in the registry. The consent process should follow local laws and regulations as applicable. 
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The ICF and DRF templates are not updated with each CIP revision unless the revision impacts the 
elements of the ICF or DRF template. The ICF and DRF can be revised independently of the CIP. 
Medtronic must approve any adaptation of the templates. For all sites requiring an ICF or DRF, the 
Ethics Board, Medtronic and regulatory authorities, if applicable, must approve the final ICF or DRF. 
10.4 Baseline 
The enrollment and baseline visit can occur at the same time. A general summary of the type of patient 
information collected at baseline includes but is not limited to: 
• 
Confirmation of eligibility 
• 
Demographics 
• 
Medical history 
• 
Baseline outcome measures for specific therapies and/or patients 
10.5 Procedures 
A general summary of the type of information collected at procedure or start of treatment includes but 
is not limited to: 
• 
Device information (e.g., model, serial number) 
• 
General relevant procedure information (e.g., placement methods & location, technique, and 
device measurements, as applicable by therapy) 
10.6 Follow-up 
Patient follow-up collection requirements are intended to generally align with the routine clinical care 
practices of the patient care providers consistent with real-world data collection. Refer to the applicable 
Condition/Therapy Appendix for follow-up frequency and data submission requirements specific to a 
given patient condition, procedure and/or therapy. 
10.6.1 Frequency of Follow-up 
At least one status update is to be reported annually for all PSR enrolled patients or until follow-up is 
complete, patient exit or death, or surveillance of the product is no longer active. 
Refer to the applicable Condition/Therapy Appendix for the follow-up/data submission requirements for 
a given patient condition, procedure and/or therapy, which may be more frequent than annually. 
The minimum follow up/data submission frequency is intended to facilitate regular updates regarding 
patient/device status and assess site reporting compliance. 
10.6.2 Modes of Data Collection 
The PSR may employ multiple modes of data collection as applicable to a given patient population 
and/or condition to ensure the most robust and reliable surveillance dataset is available for the wide 
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range of therapies and products supported within the PSR. Modes of collection may include such 
methods as: 
• 
In-office patient clinic visit 
• 
Remote technology device transmissions/uploads 
• 
Direct to patient telephone, telehealth, email, or mail contact 
• 
Web or application-based patient completed surveys 
If, in the cases of direct to patient data collection, there is any indication that the patient has 
experienced or is possibly experiencing a reportable adverse event, the PSR participating site and 
Medtronic will be notified for appropriate follow-up. 
Refer to the applicable Condition/Therapy Appendix for modes of data collection employed for a given 
patient condition, procedure and/or therapy. 
10.6.3 Follow-up Duration 
Duration of follow-up is determined by the condition, procedure, and therapy received (Refer to the 
Condition/Therapy Appendix). 
10.6.4 Lost to Follow-up 
A patient may be considered lost to follow-up when a patient's status is unknown. Confirmation that a 
patient is lost to follow-up will be obtained and documented prior to patient exit. When patients are 
lost to follow-up, registry personnel will make efforts to confirm the vital status of the patient. 
Specific processes for determining Lost to Follow up status will be outlined in the Condition/Therapy 
Appendix. 
10.7 System Modification/ Retreatment 
A system modification is any occurrence that changes either the status or the functionality (e.g., active 
to inactive) of a product. A system modification will be reported if the system or product is modified 
(e.g., electrically abandoned, explant, repositions, replacements, revisions) and can occur at any time. In 
the event of a system modification that results in the patient no longer being treated with a PSR eligible 
product (e.g., all eligible products are explanted), the patient must be exited. 
A retreatment is a treatment performed a second or subsequent time. 
Note: System Modification/Retreatment is not applicable to all Condition/Therapies; refer to the 
Condition/Therapy Appendix. 
10.8 Patient Death 
All deaths must be reported to Medtronic as soon as possible after the clinician/registry personnel first 
learns of the death. The Pl will be required to review and acknowledge patient deaths. 
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Death Classification 
Cause of death will be reported along with the clinician's assessment of product relatedness. 
Death Data Collection 
For adjudicated deaths, sufficient supporting documentation may be requested to properly adjudicate 
and classify a patient's death, if required. Provide as much of the following information as possible: 
• 
Death certificate (if allowed by state/local law) 
• 
Death summary/hospital records (if allowed by state/local law) 
• 
Autopsy report (if allowed by state/local law) 
• 
Device or image data, if applicable and available 
Further supporting evidence that is not originally provided by the site may be requested by Medtronic 
to aid in the adjudication of the death. 
10.9 Assessment of Safety 
Event trends will be analyzed by Medtronic at regular intervals. In the event of an unanticipated 
occurrence rate or trend, Medtronic will review the specific details behind those observations and 
determine what, if any, action is appropriate. Examples of the review could include determining the 
root cause of the trend, review design, manufacturing data and other collected clinical data for 
correlation. 
10.10 
Recording Data 
Data collection will be completed using printed or electronic case report forms (CRFs or eCRFs) designed 
to collect PSR reportable information. Registry personnel reporting the data are responsible for 
ensuring the accuracy and completeness of the recorded data. Visual and/or automated data checks 
will be performed by Medtronic. Procedures used for data review and issuing/resolving data 
discrepancies will be documented in a Data Management Plan. Registry personnel will be responsible 
for resolving all identified data discrepancies. 
10.11 
Deviation Handling 
A deviation is defined as an event that did not occur according to requirements specific to regulations, 
CIP and/or associated AD. Examples include but are not limited to improper or incomplete ICF or DRF, 
patient did not meet eligibility criteria, etc. 
Deviations will be reported and submitted to Medtronic each time a deviation occurs. The description of 
the deviation and justification must be documented and submitted to Medtronic. 
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Once a deviation has been identified it should be reported to Medtronic via CRF as soon as possible. 
Deviations may be identified through numerous sources, including but not limited to telephone 
conversations, site monitoring, patient record, or data review. 
It is the site's responsibility to report deviations in compliance with their Ethics Board policies and/or 
local laws. For reporting requirements, refer to Table 3. 
Medtronic is responsible for reviewing deviations and identifying any necessary corrective and/or 
preventive actions. Medtronic will determine whether any subsequent action is needed (e.g., amending 
the CIP or training). Repetitive or serious compliance issues may represent a need to initiate a 
corrective action plan and, in some cases, may necessitate suspending a site's ability to enroll until the 
problem is resolved. 
Every attempt must be made to avoid registry deviations. If the Pl and/or registry personnel anticipates, 
contemplates, or makes a conscious decision to deviate from PSR requirements, agreements or 
regulations, prior approval by Medtronic's registry team is required. In addition, prior approval is not 
necessary in situations where unforeseen circumstances are beyond the clinician's control. 
10.12 Subject Exit, Withdrawal or Discontinuation 
The rationale for patient exit should be documented in the patient's case history. Patients may be 
exited from the PSR under the following circumstances: 
• 
Patient chooses to withdraw (e.g., consent withdrawal) 
• 
Pl deems withdrawal necessary (e.g., medically justified, failure of patient to maintain adequate 
registry compliance) 
• 
Patient enrolled (signed ICF or DRF) prior to procedure or anticipated product use but procedure 
and/or product used not eligible for PSR enrollment 
• 
All enrolled eligible products are inactive (e.g., electrical abandonment, product explant) 
• 
Patient death 
• 
Patient is no longer available for follow-up (i.e., lost to follow-up, refer to 10.6.4) 
NOTE: If the patient is determined to be lost to follow up, documentation will be obtained, and 
the patient may be exited from the PSR. In addition, requirements set-forth by the Ethics Board 
must be followed by sites. 
• 
Site closure 
• 
Patient has completed PSR follow-up requirements 
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11. Risks and Benefits 
There are no expected additional benefits or risks relative to participation in the PSR as data is being 
collected on routine medical care and all products are market-released. Products eligible for enrollment 
are market-released and should be used in accordance with approved labeling. 
12. Adverse Events and Device Deficiencies 
12.1. Definitions/Classifications 
All products enrolled in the PSR are approved with demonstrated evidence of safety and effectiveness 
for their intended use. Event definitions align with the International Organization for Standardization 
standard 14155 (ISO 14155); however, products followed in the PSR are approved, not investigational, 
and the purpose of the PSR is not to demonstrate product safety and effectiveness for the purpose of 
obtaining product approval, new material or design change for medical device already on the market. 
Table 2: Adverse Event and Device Deficiency Definitions 
Adverse Event (AE} (ISO 14155}: 
Any untoward medical occurrence, unintended disease 
or injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other person, 
whether or not related to the investigational medical 
device and whether anticipated or unanticipated. 
Note 1: This definition includes events related to the 
investigational medical device or the comparator. 
Note 2: This definition includes events related to the 
procedure involved. 
Note 3: For users or other persons, this definition is 
restricted to the investigational medical device. 
Adverse Device Effect (ADE} (ISO 14155}: 
Adverse event related to the use of an investigational 
medical device. 
Note 1: This definition includes any adverse event 
resulting from insufficient or inadequate instructions for 
use or the deployment, implantation, installation, or 
operation, or any malfunction of the medical device. 
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Serious Adverse Event (SAE) (ISO 14155): 
Serious Adverse Device Effect (SADE) (ISO 
14155): 
Serious Health Threat (ISO 14155): 
Procedure-Related Adverse Event: 
Note 2: This definition includes any event resulting from 
user error or from intentional misuse of the medical 
device. 
Adverse event that: 
a) 
led to a death 
b) 
serious deterioration in the health of the 
subject, users or other persons as defined by 
one or more of the following: 
• 
a life-threatening illness or injury 
• 
a permanent impairment of a body structure or 
a body function including chronic disease 
• 
in-patient or prolonged hospitalization 
• 
medical or surgical intervention to prevent 
permanent impairment to body structure or a 
body function 
c) 
led to foetal distress, foetal death or a 
congenital abnormality or birth defect including 
physical or mental impairment. 
Note: Planned hospitalization for a pre-existing 
condition or a procedure required by the CIP, without 
serious deterioration in health, is not considered a 
serious adverse event. 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious 
deterioration in the health in subjects' users or other 
persons, and that requires prompt remedial action for 
other subjects, users or other persons. 
Note: This would include events that are of significant 
and unexpected nature such that they become alarming 
as a potential serious health hazard or possibility of 
multiple deaths occurring at short intervals. 
Adverse event that is related to the procedure of a 
device/system of interest. 
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Unantici12ated Serious Adverse Device 
Serious adverse device effect which by its nature, 
Effect {USADE) {ISO 14155): 
incidence, severity or outcome has not been identified 
in the current risk assessment. 
Device Deficiencl'. {DD) {ISO 14155): 
Inadequacy of a medical device with respect to its 
identity, durability, reliability, usability, safety or 
performance. 
Note: Device deficiencies include malfunctions, use 
errors, and inadequacy in the information supplied by 
the manufacturer including labelling. This definition 
includes device deficiencies related to the 
investigational medical device of the comparator. 
12.2. Reporting of Adverse Events & Device Deficiencies 
Timely, accurate, and complete reporting and analysis of safety information for surveillance is crucial for 
the protection of patients, clinicians, and the sponsor. Reporting and analysis of safety data are 
mandated by regulatory authorities worldwide. Medtronic has established Standard Operating 
Procedures (SOPs) to ensure compliance with global regulatory safety reporting requirements. PSR 
activities are conducted in accordance with these SOPs. Since the safety reporting requirements and 
classification systems vary for each regulatory agency, requirements from the geographies are t aken 
into account. 
Only a subset of AEs will be reported. Events reportable to Medtronic as applicable for a given patient 
population include: 
• 
Device-Related 
• 
Procedure-Related 
• 
Therapy-Relevant 
Adverse events associated with users, or other persons than the patient, will not be captured in the 
registry, but should be reported through standard global complaint handling processes. 
Only reportable events as defined in the Condition/Therapy Appendix are required to be submitted to 
Medtronic and all must be reported upon the site's first awareness of the occurrence. Refer to the 
Therapy/Condition Appendix for additional details, anticipated events, and a list of non-reportable 
events, if applicable. 
The site will report any updates to an event for any changes in status of a previously reported event (i.e., 
change in action, change in outcome, and change in relatedness). 
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Any supporting evidence that could assist in the assessment and classification of the event may be 
requested (e.g., device data). Further supporting evidence that is not originally provided by the site may 
be requested by Medtronic to aid in the adjudication of an event. 
All events will be followed until the event has resolved, is ongoing with no further actions to be taken, 
patient exit or registry closure, whichever occurs first. 
The reporting Pl and/or registry personnel is required to follow any reporting requirements of their 
Ethics Board and local or national law. 
The site will report the clinician's assessment of the event relative to relatedness (e.g., device or 
procedure) and seriousness. Upon receipt of the events at Medtronic, a Medtronic representative will 
review for completeness and when necessary will request clarification and/or additional information 
from the site. 
Regulatory reporting of Adverse Events will be completed according to local and national law and 
regulatory requirements. Refer to Table 3 and Table 4 for a list of required site and Medtronic reporting 
requirements. It is the responsibility of the site to comply with the Adverse Event reporting 
requirements of their Ethics Board. 
All sites are required to follow their local regulatory reporting requirements for market-released 
products. 
Device deficiencies information will be collected throughout the registry and be reported to Medtronic 
upon site's first awareness. Specific event reporting requirements may be outlined for a given 
condition, procedure and/or therapy in the Condition/Therapy Appendix. 
13. Data Review Committees 
A Clinical Event Committee (CEC) may conduct a review of reported events and deaths at regular time 
intervals, if applicable. The need for CEC review will be determined by Condition/Therapy and the end 
use of the data (e.g., regulatory reporting, publications, etc.). Use of a CEC will be documented in the 
associated AP or AD. The CEC is a committee comprised of independent experts with applicable 
technical and clinical backgrounds. 
The committee will be provided with the reporting clinician's assessment of the event and actions taken. 
The committee is responsible for reviewing the clinician's assessment and adjudicating the event as 
applicable. If the CEC disagrees with the clinician's assessment, the rationale will be provided to the 
clinician. Both determinations are retained. The CEC determination will be used for analysis purposes. 
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14. Statistical Design and Methods 
The purpose of the PSR is to better characterize the safety and/or performance of market-released 
products, therefore sample size calculations serve to ensure sufficient precision for characterization of 
performance. The exact definition of sufficient precision will vary based on the intended end use of the 
data and product type. The general concept is that sample sizes should be large enough to generate 
meaningfully narrow confidence intervals for population parameters of interest. Specific analysis 
requirements, statistical methods including required effective sample size determinations are defined in 
the PSR associated AP or AD; refer to Section 6.2. 
Medtronic reserves the right to limit or close enrollment to minimize potential bias. Fifteen percent 
(15%) of an estimated total projected enrollment may be used as a guideline for determining if a 
product should be closed to enrollment at a particular site. Site specific enrollment closure for a product 
will be communicated in writing to the individual impacted site. 
15. Ethics 
15.1.Statement(s) of Compliance 
All products will be followed per the CIP, associated addendums (if applicable), ethical principles that 
have their origin in the Declaration of Helsinki and in accordance with Good Clinical Practices (GCP), 
which includes, but not limited to, Federal Regulations (21 CFR Part 11, 50 and 56), ISO 14155 and 
applicable regional/local regulations. 
The Declaration of Helsinki principles have been implemented in the PSR, by means of the patient data 
release or informed consent process, Ethics Board approval or a written statement by the Ethics Board 
Chairperson or Pl stating that approval is not required or documentation that approval is not required 
per local law, training, public clinical trial registration (e.g., clinicaltrials.gov, etc.), risk benefit 
assessment, publication policy, etc. 
PSR activities shall not begin until all required approvals and documents from the Ethics Board and 
regulatory authorities, if needed, have been received. Any additional requirements imposed by the 
Ethics Board or regulatory authority shall be followed, as appropriate. 
Medtronic contracts with participating institutions/investigators through a CTA that defines the scope 
and responsibilities and associated compensation related to carrying out the obligations under a clinical 
registry sponsored by Medtronic. 
The registry has been intentionally designed to collect data on routine clinical care practice with market 
released products for the purpose of product surveillance. Due to the registry design, there are some 
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exceptions that apply to the above regulations. A list of exceptions is maintained under a separate 
cover. 
16. Study Administration 
16.1. Monitoring 
Medtronic uses a risk-based approach to monitor the regulatory and reporting compliance of the PSR to 
ensure the overall integrity and quality of the data through the following combination of the actions: 
• 
Automated data logic checks 
• 
Statistical analysis to identify data trends or anomalies 
• 
Statistical analysis to identify sites that are outliers relative to other participants 
• 
Source verification using available in-house data (e.g., data transmission) 
• 
Regulatory and reporting compliance trends 
• 
Interim clinical monitoring visits 
• 
Site Audits 
The aggregate of activities will provide a measurable level of confidence in the dataset. The respective 
PSR Monitoring Plan will define, in greater detail, the risk-based approach for PSR monitoring. 
Trained sponsor representatives or delegates appointed by Medtronic may perform registry monitoring 
in order to ensure that the registry is conducted in accordance with the CIP, the CTA, and applicable 
regulatory and local requirements. Medtronic, or delegates, must therefore be allowed access to the 
patient's case histories (clinic and hospital records, and other source data/ documentation) upon 
request as per the CTA and Informed Consent (ICF) or Data Release Form (DRF), as applicable. 
During monitoring visits, the monitor will perform monitoring activities by review of original patient 
documents. The monitor must have direct access to original source documentation, certified copies of 
the original source, or supervised access in situations where direct access is not possible. 
16.2. Data Management 
Data will be collected using an electronic data management system or data transmissions, and manually 
via paper CRF if required. Data reporting by the site will be completed and submitted by persons with 
applicable documented training (i.e. authorized persons). All data will be stored in a secure, password-
protected database. Access to all reported data will be controlled by Medtronic. 
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The accuracy and completeness of site reported data will be confirmed with an approval by the Pl or 
authorized designee. 
Medtronic will review site reported data to monitor data quality, data discrepancies will be created as 
required and forwarded to the site for resolution. Registry personnel are responsible for the timely 
submission of data and the resolution of discrepancies. 
The Pl should create and maintain documentation of the type and location of source documents. All 
reported data elements should be supported in the patient's case history (i.e., source documentation). 
Any time the database reported data are the only record, it should be appropriately documented with 
rationale. In these cases, an alternate method of source documentation is highly recommended. 
For products capable of transmitting data, device data uploads/transmissions will be collected for 
Medtronic products only. These data will be obtained directly from the submitted device file (e.g., 
transmission, etc.) therefore, additional source verification will not be required. Upon receipt, device 
data will be maintained and retrieved for analysis and reporting. 
16.3. Direct Access to Source Data/ Documents 
The site shall provide direct access to source data for monitoring, audits, EC review, adjudication of 
events and regulatory authority inspections, per local regulatory requirements. As required, permission 
for direct access to source documents from the patient, hospital administration and national regulatory 
authorities shall be obtained. 
16.4. Confidentiality 
Confidentiality of data shall be observed by all parties (e.g., Medtronic, regulatory bodies, etc.) and all 
data shall be secured against unauthorized access. The privacy of each patient and confidentiality of 
his/her information shall be preserved in reports and when publishing any data, in accordance with local 
laws and regulations. 
16.5. Liability 
Warranty information is provided in the product packaging for the market released products. Package 
requirements may vary by geography. 
Medtronic maintains appropriate clinical liability insurance coverage as required under applicable laws 
and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a clinical insurance statement/certificate will be provided to the Ethics Board. 
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16.6. CIP Amendments 
A CIP Amendment will be prepared when there are significant changes, corrections, or modifications 
that impact patient safety, ethical conduct, data integrity, or design. All revisions will be documented in 
the version history and require Ethics Board and Medtronic approval, and Regulatory Authority 
approval, if applicable. 
16.7. Record Retention 
16.7.1 
Site Records 
The site is responsible for the preparation and maintenance of records cited below. Records are subject 
to inspection by Medtronic for compliance and should be retained for 2-years from the last patient 
follow-up or longer, if required by local law or site policy. 
• 
All essential correspondence and approvals that pertains to the PSR, including that with the 
Ethics Board, Medtronic or regulatory body 
• 
Fully executed original CTA between site and Medtronic 
• 
CIP, ICF or DRF form (all approved versions) 
• 
PSR Associated Addendums, if applicable 
• 
Registry personnel training documentation 
• 
Any other records required by a regulatory authority or applicable standard (e.g., delegation log, 
financial disclosure (FD)/conflict of interest statement) 
• 
Patient's case history records, per applicable standards, including: 
o 
All patient completed DRF or ICF forms 
o 
All patient authorizations, (applicable geographies) 
• 
Reportable Events and Deaths 
• 
Device Deficiencies 
The Pl is responsible for ensuring practicing clinicians are appropriately licensed/qualified. Medtronic 
will not inspect these records to assess compliance to institutional policy, regulations, or local law. 
Medtronic representatives or regulatory authorities may perform auditing activities if deemed necessary 
to evaluate the conduct of PSR activities. 
16.7.2 
Medtronic Records 
Medtronic will maintain the following records for each site: 
• 
All related essential correspondence that pertains to the site 
• 
Fully executed CTA 
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• 
All Ethics Board approval or determination (Ethics Board waiver) documentation 
• 
All approved CIP versions 
• 
All approved DRF, ICF and Authorization forms (authorization forms in applicable geographies) 
• 
All reported data including CRFs, images, device data obtained via remote transmission or 
device uploads for applicable products, medical information received to support adjudication of 
adverse events and deaths. 
• 
Training, compensation, monitoring records 
Other records required per local regulations will be maintained. 
16.8. Reporting Requirements 
16.8.1. 
Site Reports 
The site is responsible for the preparation and submission of the reports to Medtronic and/or the Ethics 
Board cited in Table 3. In addition, if an Ethics Board takes any action with respect to PSR pertinent 
documentation it must be forwarded to Medtronic. Sites are responsible to submit reports per 
applicable regulations to all required parties. 
Table 3: Site Reports 
Report 
Submit To 
Description 
Withdrawal of 
Medtronic 
Notification within five working days 
Ethics Board 
approval 
Other actions by 
Medtronic 
Any actions taken by the Ethics Board that affects any aspect 
Ethics Board 
of the PSR conduct must be submitted to Medtronic as soon 
as possible. 
Deaths 
Medtronic 
The site must submit notification of all deaths to Medtronic 
Ethics Board (as required) 
and licensing authority, if applicable per local law, upon site's 
first awareness. The site must also report to their Ethics 
Board per their requirements/local law. 
Adverse Events 
Medtronic 
The site must submit all Adverse Events (device, procedure-
Ethics Board (as required) 
related and therapy-relevant) to Medtronic and licensing 
authority, if applicable per local law, upon site's first 
awareness. The site must also report to their Ethics Board 
per their requirements/local law. 
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Report 
Submit To 
Description 
Deviation 
Medtronic 
Deviations should be reported to Medtronic and to Ethics 
Ethics Board (as required) 
Boards, competent authorities or other regulatory bodies per 
their requirements and/or local law. 
16.8.2. 
Medtronic Reports 
Medtronic will complete reports per product-specific requirements, as shown in Table 4. Medtronic will 
comply to any local reporting requirements, if applicable. Medtronic may also provide participating sites 
with periodic reports that will present both site PSR status and aggregate information. In addition, 
participating sites will have access to their own registry data for ad hoc reporting. 
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Table 4: Medtronic Reports 
Report 
Submit to 
Description 
Progress Report 
Regulatory 
Progress reports will be submitted to regulatory authority as 
Authority 
required, and to Pl & Ethics Boards as requested. 
Adverse Events 
Regulatory 
Summary of reportable Events will be provided to Regulatory 
Authority 
Authorities per their requirements, (any negative trends will be 
Ethics Board 
reported to participating clinicians as appropriate). Summary of 
reportable Events may be provided to other applicable parties as 
required per local regulations. 
Withdrawal of Ethics 
Participating 
Notification within five working days after the sponsor first learns 
Board approval 
Sites 
of the withdrawal of approval. 
Regulatory 
To be reported to Regulatory Authorities as required. 
Authority 
Withdrawal of 
Participating 
Notification within five working days after sponsor first learns of 
regulatory approval, if 
Sites 
the withdrawal of approval. 
applicable 
Ethics Board 
To be reported to Regulatory Authorities as required. 
16.9. Publication and Use of Information 
Sites may publish the results of and information from their PSR collected data provided the publication 
is made in accordance with the terms and conditions of the agreement between the site and Medtronic. 
Publications utilizing PSR data will be processed in accordance with Medtronic Standard Operating 
Procedures and Policies. A publication strategy designed to provide direction and support in the 
development of clinical publications may be utilized. The strategy will outline the number of 
committees, membership criteria, authorship criteria, criteria for developing manuscripts, abstracts and 
public presentations, publication approval and publication timelines. 
16.9.1. 
Publication Committees 
The PSR may have multiple Publication Committees to align with numerous therapies or products 
supported by the PSR. Medtronic will assess recommendations put forth by the committees and will 
review and comment on publications. Committees may be at a therapy or product level as warranted by 
the intended use of the data. Members may include, but are not limited to, participating clinicians, 
team members, and Medtronic representatives including research scientists, statisticians, and others as 
applicable. 
The Publication Committees are responsible for the following: 
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• 
Overseeing the development of manuscripts and abstracts 
• 
Reviewing, approving and prioritizing publications 
• 
Providing input on the scientific merit and clinical relevance of publications 
• 
Applying and enforcing the authorship guidelines set forth in the publication strategy 
Publication Committee membership does not automatically qualify a member for authorship. 
16.9.2. 
Criteria for Determining Authorship 
Authorship for manuscripts will follow the Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals, ICMJE guidelines (www.icmje.org) and be based on the following criteria: 
• 
Substantial contributions to the conception or design of the work; or the acquisition, analysis or 
interpretation of data for the work; AND 
• 
Drafting the work or revising it critically for important intellectual content; AND 
• 
Final approval of the version to be published; AND 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
In addition, the following should be implemented: 
• 
First author and all subsequent authorship will be determined by contribution to each of the 
above criteria. All authors must sign the manuscript that will be submitted. 
• 
A minimum of verbal approval prior to submission is the minimum required for an abstract. 
• 
All clinicians not listed as co-authors will be acknowledged and will be individually listed in an 
appendix as permitted by the scientific journal. 
• 
Medical writer support must be disclosed either by inclusion of the medical writer as an author 
or in the Acknowledgements, depending on the contribution. 
16.9.3. 
Publication Requests 
Publication requests will be evaluated for scientific validity and the ability of Medtronic to provide 
resources. They will be approved by the responsible Publication Committee which will need to ensure 
that requests do not present conflicts with other geographical regions. If multiple geographies 
contribute data, co-authorship will be determined using the guidelines for authorship selection 
described above. 
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16.9.4. 
Publication of Results 
A description of the clinical registry shall be registered in a publicly accessible database. Results will be 
made publicly available. 
16.10. Suspension or Early Termination 
Suspension is a temporary postponement of PSR activities relating to enrollment at a site or at a registry 
level. Termination is the termination of site PSR activities at a site or at a registry level. 
16.10.1. Criteria for Suspension or EarlyTermination 
Reasons for suspension or termination of a site may include but is not limited to: 
• 
Ethics Board approval expiration 
• 
Consistent non-compliance to the CIP (e.g., failure to follow patients, etc.) 
• 
Lack of enrollment 
• 
Non-compliance to regulations and the terms of the CTA with Medtronic 
• 
Ethics Board suspension of the site 
Considerations related to PSR suspension and termination include but is not limited to: 
• 
If Medtronic suspends or terminates the PSR, Medtronic will promptly inform the site of the 
suspension/termination along with the reason and inform regulatory authorities, where 
required. 
• 
If Medtronic suspends or terminates the PSR, the site must inform the patients, where required. 
• 
In the case of PSR suspension or termination, for reasons other than a temporary Ethics Board 
approval lapse, the site will promptly inform the Ethics Board, if applicable 
If the site suspends or terminates participation without prior agreement of Medtronic: 
• 
The site must promptly inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The site must promptly inform the institution (where required per regulatory requirements) 
• 
The site must promptly inform the Ethics Board, if applicable 
• 
The site must inform the patients, where required. 
If the Ethics Board suspends or terminates its approval: 
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• 
The site must promptly inform Medtronic and provide a detailed written explanation of the 
termination or suspension within five business days 
• 
Patient enrollment must stop until the Ethics Board suspension is lifted 
• 
Patients already enrolled should continue to be followed in accordance with the Ethics Board 
policy or its determination that an overriding safety concern or ethical issue is involved 
• 
The site must inform his/her institution (where required per local requirements) 
• 
The site must promptly inform the patients, where required. 
17. References 
Brown, L., Bright, R., Tavros, D., Medical Device Epidemiology and Surveillance, Wiley Publishing 2007 
Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and 
Guidelines, Heart Rhythm, Volume 3, No. 10, October 2006 
Gliklich RE, Dreyer NA: Registries for Evaluating Patient Outcomes: A User's Guide. 2nd Edition. AHRQ 
publication No. 13-EHClll. April 2014 
18. Appendices 
Surgical Condition/Therapy Appendix 
19. Version History 
Version history is maintained within a separate document. 
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Condition/Therapy Appendix: Surgical 
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A. 
Surgical and Medical Procedure Background 
The Product Surveillance Registry (PSR) supports a wide range of surgical and medical procedures 
completed using one or more Medtronic products in open, minimally invasive, robotic, endoscopic, and 
percutaneous procedures. 
Often classified as the 'traditional type' of surgery, open surgery occurs when incisions are made in a 
patient through which surgeons insert various instruments to conduct the surgery. 
Minimally invasive surgery (MIS) is a technique where operations are performed through small incisions 
in the body whereby surgical instrumentation are inserted allowing the procedure to be performed with 
minimal tissue interruption (e.g. laparoscopic surgery). 
Robot-assisted laparoscopic surgery utilizes a Robotic Assisted Surgical Device (RASD) to provide three-
dimensional visualization and articulation of the robotic instrument wrists. 
Additionally, endoscopic and percutaneous surgical procedures offer additional options to perform MIS. 
Endoscopic surgeries involve the insertion of a long, thin tube, typically with the use of a camera and 
light, directly into the body to perform a surgical procedure. 
Percutaneous surgery is characterized by being done through one or more small puncture sites or minor 
incisions through the skin, often without direct visualization of the underlying anatomy. 
Details on each of the market approved study devices (including e.g. device description, contra-
indications and potential complications) are included in the current applicable version of the 
Instructions for Use document. 
B. Data Collection 
Steps to minimize bias in the PSR Surgical patient population align with Section 6.3 (Steps Taken to 
Minimize Bias). These steps are followed to ensure enrollments are an appropriate representation of the 
patient population. Product specific known or foreseeable factors available in product labeling/I FU may 
be taken into consideration. Medtronic may limit enrollment using an Enrollment Guide to account for 
specific cohorts of product use and ensure adequate enrollments to effectively assess study objectives. 
B.1 
Enrollment 
Patients may be enrolled prior to or after the surgical or medical procedure. Whether a particular cohort 
under this CIP enrolls patients before or after surgery or both, is defined in the applicable analysis plan 
or addendum. The site will make every attempt to approach all eligible patients for enrollment and 
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perform a thorough review of the patient's medical record to ensure requested baseline and medical 
history information is complete. When enrolling a patient before surgery, procedures are recommended 
to occur within 30 days of consent. When enrolling a patient after surgery, it is recommended to do so 
within 30 days following the procedure. If deemed necessary, the study team is allowed to deviate from 
those 30 days before or following surgery, provided justification in the applicable analysis plan or 
addendum. 
If the patient is enrolled into the registry prior to the surgical or medical procedure but the procedure is 
not completed with an eligible product, the patient will be exited from the registry. The data that is to 
be collected on patients exited early will include the Enrollment CRF and the Exit CRF at minimum. Other 
CRFs, if collected, will be defined in the applicable analysis plan or addendum. No data will be collected 
after the patient is exited. Vulnerable patient populations such as pediatric patients may be enrolled 
when the use of the device is approved in the population and region per the applicable instructions for 
use (IFU). Regional requirements will be followed and described in the applicable analysis plan or 
addendum. 
Sites may submit to their Ethics Board for a full waiver of consent if applicable. Patients at sites where 
the Ethics Board has not granted a full waiver of consent are considered enrolled once informed consent 
has been obtained. Patients at sites where the Ethics Board has granted a full waiver of consent are 
considered enrolled once the patient's eligibility is assessed and verified and the Enrollment CRF is 
complete. Relevant enrollment data collected for eligible patients include but are not limited to: 
• 
Eligibility verification (i.e. Section 8.3 Inclusion Criteria and Section 8.4 Exclusion Criteria). 
Study activities (e.g., data collection and entry) can only start after the patient is enrolled in the study. 
B.2 
Baseline 
The following types of data may be collected at baseline for enrolled patients regardless of procedure 
performed: 
• 
Demographics 
• 
Medical History 
• 
Surgical History 
• 
Vital signs 
• 
Quality of Life or satisfaction measurements, if applicable 
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8.3 
Procedure 
The following types of data may be collected for enrolled patients as applicable for the procedure 
performed: 
• 
Perioperative details 
• 
Device details 
• 
Adverse Events, Device Deficiencies, Deaths, and deviations are to be reported to Medtronic 
upon awareness 
• 
Imaging, if applicable 
• 
Procedure recordings, if applicable 
• 
Quality of Life or satisfaction measurements, if applicable 
8.4 
Follow-up Reporting Frequency & Data Collection 
Patients will be treated in accordance with the routine clinical practices of their respective care 
provider. However, in 'real world' clinical practice, the frequency of in-person follow-up visits may vary 
for many reasons (e.g., patient's personal circumstances, condition, physician preference, etc.) 
resulting in more or fewer in-person visits. 
As a result, the PSR is based on an active surveillance model which requires sites to complete a patient 
status assessment post-procedure, regardless of whether the patient is seen in-person per the 
physician's routine follow-up care practices. This approach ensures a robust dataset while increasing 
the continual awareness of patient status throughout their registry participation. 
Data will be captured through 30 days post-procedure (to be reported between day 30 and 37) at a 
minimum and may be captured up to 60 months (or 5 years) post-procedure ( Figure 1). 
For procedures requiring long-term follow-up data, assessments will be collected at least annually with 
a maximum follow-up duration of 60 months at which time the patient will be exited (Figure 1). The 
total duration of follow-up for products requiring long-term follow-up data collection will be 
determined by various factors including but not limited to product lifecycle, recurrence rate, or 
regulatory requirements. The timing of the patient assessments and exit will be outlined in the 
corresponding Analysis Plan or Addendum. Refer to Figure 2 for an example of a long-term follow-up 
data collection schedule. 
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Surgical Appendix - Figure 1: Follow-up Schedules 
Short-term Schedule 
Long-term Schedule 
Procedure 
L 
Day0 
Procedure 
Report events. reinterventions. and deviations upon awareness 
Additional Assessments at least annually up to 60 Months 
Day30 
60 Months 
(5 Years) 
Surgical Appendix - Figure 2: Example of a Long-term Schedule 
Example Long-term Schedule 
Report events, relnterventions, and deviations upon awareness 
Asse 
ent 1: 
DayO 
3 
ays 
( 
ays) 
Asses m nt 2: 
3 mon hs 
(+2 weeks) 
6Month 
Ass 
1 
(+ 
12 Month 
I 3: 
hs 
th) 
18 Month 
24 Month 
Follow-up data will be collected for enrolled patients and may include, but are not limited to: 
• 
Patient status 
• 
Readmissions 
• 
Imaging information, if applicable 
• 
Procedure recordings, if applicable 
• 
Quality of Life or satisfaction measurements, if applicable 
• 
Adverse Events, Device Deficiencies, Deaths, reinterventions, and deviations are to be reported 
to Medtronic upon awareness 
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8.5 Events 
All procedure or device related events are to be reported upon site awareness. Submit any additional 
supporting evidence which could assist in the assessment and review. Further supporting evidence not 
originally provided by the site may be requested by Medtronic to aid in the adjudication of the event. 
Refer to Table 1 below for Unavoidable Adverse Events, which if resolved within the timeframe 
specified, are not required to be reported. 
Surgical Appendix - Table 1: Unavoidable Adverse Events 
Event Description 
Time Frame (hours) from 
end of Procedure 
Anesthesia related nausea/ vomiting/ headache 
24 hours 
Low-grade fever (<100°F or< 37.8°() 
48 hours 
Pain at Access Site 
72 hours 
Mild to moderate bruising/ ecchymosis at access site 
168 hours (7 days) 
Back pain related to lying on the table 
72 hours 
Constipation 
72 hours 
Postoperative pain and/or complications that the Investigator considers common and within normal 
limits for the procedure and its related medication. 
Refer to Table 2 below, for a listing of potential reportable Adverse Events. The listing is provided to 
facilitate more complete and consistent reporting and is not intended to be a comprehensive listing of 
all reportable events. 
Patients with adverse events that have not resolved at the time of the final registry timepoint will be 
followed until resolution, for up to 30 days after the final registry timepoint, or other applicable period 
as defined in the analysis plan or addendum. 
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Surgical Appendix -Table 2: Potential Reportable Adverse Events 
Allergic reactions 
Inflammatory reaction 
Seroma 
Bleeding/hematoma 
Inadvertent injuries to other 
Thromboembolic complications 
tissues or organs 
Blood transfusion 
Nerve damage 
Vascular injury 
Cardiopulmonary complications 
Nerve entrapment 
Visceral adhesions 
Chronic pain 
Hernia Recurrence 
Visceral injuries 
Damage to pericardium 
Renal failure 
Wound dehiscence 
Infection 
Respiratory complications 
The site will report the clinician's assessment of an adverse event relative to relatedness (e.g., device or 
procedure), seriousness and severity. The definitions for seriousness and relatedness can be found in 
section 12.1, Table 2: Adverse Event and Device Deficiency Definitions. The definitions for severity are 
in Table 3 below. 
Surgical Appendix - Table 3: Definitions for Event Severity 
Event type 
Severity Definition 
Mild event 
Signs, or symptoms that are easily tolerated by the subject, or are 
clinical or diagnostic observations of the investigator. 
Moderate event 
Signs, or symptoms that cause discomfort and interfere with normal 
functioning. Local or non-invasive intervention may be indicated. 
Severe event 
Signs, or symptoms that disable the subject, are medically 
significant, lead to hospitalization or prolongation of hospitalization. 
B.6 Lost to Follow-up 
Follow-up data may be collected via medical record review within the expected reporting period. In 
cases where a subject interaction is required for a study endpoint, subjects may be considered lost to 
follow-up if at least two attempts to contact the subject are unsuccessful. The method of attempt (e.g., 
one letter and one phone record, or two letters) must be documented in the subject's source 
documentation. In addition, regulation set forth by the governing EC/IRB must be followed. 
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8.7 Exit 
Enrolled patients will be exited from the registry once the applicable duration of follow-up has been 
completed unless exited early for unavoidable reasons. Patients with an ongoing reportable Adverse 
Event or Device Deficiency at the time of final registry time point will be followed until resolution for 
up to 30 days after the final registry timepoint, or other applicable period as defined in the analysis 
plan or addendum. 
8.8 Schedule of Data Collection 
Surgical Appendix - Table 4: Data Collection Schedule 
Enrollment and 
Follow-up 
Procedure 
Baseline 
Assessment 
Informed Consent, if applicable 
X 
Patient status 
X 
X 
Demographics and Medical and 
X 
Surgical History 
Vital signs 
X 
X 
X 
Procedure information 
X 
Imaging, if applicable 
X 
X 
X 
Product and/or therapy 
X 
X 
X 
information, if applicable 
Quality of Life or satisfaction 
X 
X 
X 
measurements, if applicable 
Readmission 
X 
Reintervention 
Reported upon site awareness 
Procedure/Device Related 
Reported upon site awareness 
Adverse Events 
Device Deficiencies 
Reported upon site awareness 
Deaths 
Reported upon site awareness 
Deviations 
Reported upon site awareness 
C. Data Collection Details 
Data collection details and CRFs (where required) are provided under separate cover. 
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