Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Reveal LINQTM for COPD Study Clinical Investigation 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title Reveal LINQTM for Chronic Obstructive Pulmonary 
Disease (COPD) 
Clinical Investigation Plan Identifier MDT19019 
Study Product Name Reveal LINQTM Insertable Cardiac Monitor (ICM) 
System 
Sponsor/Local Sponsor Sponsor: 
Medtronic, Inc US 
8200 Coral Sea Street NE 
Mounds View, MN U.S.A. 55112 
Phone: 1-800-328-2518 
Document Version 5.0 
Version Date 1-DEC-2022 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 

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Table of Contents 
 
Table of Contents ........................................................................................................................2 
1. 
Administrative Information .................................................................................................7 
1.1 Sponsor Contact Information ..................................................................................................... 7 
2. 
Glossary ...............................................................................................................................7 
3. 
Synopsis ........................................................................................................................... 10 
4. 
Introduction ..................................................................................................................... 14 
4.1 Background ............................................................................................................................ 14 
4.2 Purpose ................................................................................................................................. 15 
5. 
Objectives and/or Endpoints ............................................................................................ 16 
5.1 Objectives .............................................................................................................................. 16 
5.1.1 
Primary Objective(s) ............................................................................................................ 16 
6. 
Study Design .................................................................................................................... 17 
6.1 Duration ................................................................................................................................ 18 
6.2 Rationale ............................................................................................................................... 18 
6.3 Study Oversight ...................................................................................................................... 19 
7. 
Product Description .......................................................................................................... 19 
7.1 General ................................................................................................................................. 19 
7.1.1 
Reveal LINQTM Insertable Cardiac Monitor (ICM) ................................................................ 20 
7.1.2 
Incision Tool ......................................................................................................................... 21 
7.1.3 
Insertion Tool....................................................................................................................... 21 
7.1.4 
2090 Programmer ............................................................................................................... 22 
7.1.5 
Medtronic Investigational RAMware ................................................................................... 22 
7.1.6 
Patient Assistant .................................................................................................................. 23 
7.1.7 
MyCareLink ® Home Monitor .............................................................................................. 24 
7.1.8 
DR 220 Holter Monitor ........................................................................................................ 24 
7.1.9 
EMFIT QS + CARETM Bed Monitor ........................................................................................ 25 
7.2 Manufacturer ......................................................................................................................... 25 
7.3 Packaging .............................................................................................................................. 26 
7.4 Intended Population ............................................................................................................... 26 

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7.5 Product Use ........................................................................................................................... 26 
7.6 Product Training Materials ....................................................................................................... 26 
7.7 Shipment of Study Components ............................................................................................... 26 
7.8 Product Receipt and Tracking .................................................................................................. 27 
7.9 Product Storage ..................................................................................................................... 27 
7.10 Product Return ....................................................................................................................... 28 
7.11 Product Accountability ............................................................................................................. 28 
7.11.1 
CareLink Programmer .......................................................................................................... 29 
7.11.2 
Reveal LINQ ICM .................................................................................................................. 29 
7.11.3 
Patient Assistant .................................................................................................................. 29 
7.11.4 
Holter DR220 ....................................................................................................................... 29 
7.11.5 
EMFIT QS+CARETM bed monitor .......................................................................................... 29 
8. 
Study Site Requirements .................................................................................................. 29 
8.1 Investigator/Investigation Site Selection ................................................................................... 29 
8.2 Study Site Activation ............................................................................................................... 30 
8.3 Role of the Sponsor Representatives ........................................................................................ 30 
9. 
Selection of Subjects ........................................................................................................ 31 
9.1 Study Population .................................................................................................................... 31 
9.2 Subject Enrollment ................................................................................................................. 31 
9.3 Inclusion Criteria .................................................................................................................... 31 
9.4 Exclusion Criteria .................................................................................................................... 32 
10. 
Study Procedures .......................................................................................................... 32 
10.1 Schedule of Events ................................................................................................................. 32 
10.2 Data Collection ....................................................................................................................... 33 
10.3 Scheduled Follow-up Visit Windows ......................................................................................... 34 
10.4 Subject Screening ................................................................................................................... 34 
10.5 Subject Consent ..................................................................................................................... 35 
10.6 Enrollment ............................................................................................................................. 36 
10.7 Baseline ................................................................................................................................. 36 
10.8 Implant ................................................................................................................................. 37 
10.8.1 
Device Programming Requirements .................................................................................... 38 

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10.9 EMFIT-QS+CARE™ Bed Monitor .............................................................................................. 38 
10.10 
Weekly Subject Diary ....................................................................................................... 38 
10.11 
Bi-Weekly CareLink Transmissions .................................................................................... 39 
10.12 
Scheduled Follow-up Visits ............................................................................................... 39 
10.12.1 
Phone Follow-up Visit (every 3 months) ......................................................................... 39 
10.12.2 
In-Office Follow-up Visit (optional).................................................................................. 39 
10.13 
Spirometry Test .............................................................................................................. 40 
10.13.1 
Assessment of Tidal Volume ........................................................................................... 40 
10.13.2 
Standard Forced Spirometry Test .................................................................................... 41 
10.14 
Chest X-ray ..................................................................................................................... 41 
10.15 
Holter............................................................................................................................. 41 
10.16 
Device Interrogation ........................................................................................................ 41 
10.17 
System Modification ........................................................................................................ 41 
10.18 
Medications Assessment .................................................................................................. 42 
10.19 
Assessment of Safety ...................................................................................................... 42 
10.20 
Review of Data Recorded by the Reveal LINQTMDevice ....................................................... 42 
10.21 
Recording Data ............................................................................................................... 42 
10.22 
Deviation Handling .......................................................................................................... 43 
10.23 
Subject Exit, Withdrawal or Discontinuation....................................................................... 44 
10.23.1 
Study Exit ......................................................................................................................... 44 
10.23.2 
Study Completed ............................................................................................................. 45 
10.23.3 
Lost to Follow-up ............................................................................................................. 45 
10.23.4 
Subject Chooses to Exit (i.e. Revokes Consent) ............................................................... 45 
10.23.5 
Investigator Withdraws Subject ...................................................................................... 45 
10.23.6 
Conditional Disengagement ............................................................................................ 45 
11. 
Risks and Benefits ......................................................................................................... 46 
11.1 Potential Risks ........................................................................................................................ 46 
11.2 Risk Minimization .................................................................................................................... 47 
11.3 Potential Benefits ................................................................................................................... 50 
11.4 Risk-Benefit Rationale ............................................................................................................. 51 
12. 
Adverse Events and Device Deficiencies ........................................................................51 

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12.1 Adverse Events ...................................................................................................................... 51 
12.2 Device Deficiency ................................................................................................................... 52 
12.3 Processing Updates and Resolution .......................................................................................... 52 
12.4 Definitions/Classifications ........................................................................................................ 52 
12.5 Reporting of Adverse Events ................................................................................................... 58 
12.5.1 
Adverse Event and Device Deficiency Classification ............................................................ 58 
12.5.2 
Adverse Event and Device Deficiency Reporting Requirements ......................................... 59 
12.6 Subject Death ........................................................................................................................ 61 
12.6.1 
Death Classification and Reporting ..................................................................................... 61 
12.7 Product Complaint Reporting ................................................................................................... 62 
13. 
Data Review Committees .............................................................................................. 62 
13.1 Event Adjudication Committee ................................................................................................. 62 
13.2 CRO ...................................................................................................................................... 63 
14. 
Statistical Design and Methods ..................................................................................... 63 
14.1 General Aspects of Analysis ..................................................................................................... 63 
14.2 Analysis Execution .................................................................................................................. 64 
14.3 Primary Objective ................................................................................................................... 64 
14.3.1 
Hypothesis ........................................................................................................................... 64 
14.3.2 
Endpoint Definition ............................................................................................................. 64 
14.3.3 
Analysis Methods ................................................................................................................ 64 
14.3.4 
Determination of Subjects/Data for Analysis ...................................................................... 64 
14.4 Sample Size Determination ...................................................................................................... 65 
14.5 Minimization of Bias ................................................................................................................ 65 
14.6 Missing data ........................................................................................................................... 65 
14.7 Additional Considerations Due to COVID-19 .............................................................................. 66 
15. 
Ethics ............................................................................................................................ 66 
15.1 Statement(s) of Compliance .................................................................................................... 66 
16. 
Study Administration .................................................................................................... 67 
16.1 Monitoring ............................................................................................................................. 67 
16.1.1 
Monitoring Visits ................................................................................................................. 67 
16.2 Data Management .................................................................................................................. 68 

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16.3 Direct Access to Source Data/Documents ................................................................................. 68 
16.4 Confidentiality ........................................................................................................................ 68 
16.5 Liability .................................................................................................................................. 68 
16.6 CIP Amendments .................................................................................................................... 69 
16.7 Record Retention .................................................................................................................... 69 
16.7.1 
Investigator Records ............................................................................................................ 69 
16.7.2 
Sponsor Records .................................................................................................................. 70 
16.8 Reporting Requirements .......................................................................................................... 70 
16.8.1 
Investigator Reports ............................................................................................................ 70 
16.8.2 
Sponsor Reports .................................................................................................................. 71 
16.9 Publication and Use of Information .......................................................................................... 72 
16.9.1 
Publication Committee ........................................................................................................ 72 
16.9.2 
Management of Primary, and Ancillary Publications........................................................... 73 
16.9.3 
Criteria for Determining Authorship .................................................................................... 73 
16.9.4 
Transparency ....................................................................................................................... 74 
16.10 
Suspension or Early Termination ...................................................................................... 74 
16.10.1 
Planned Study Closure ..................................................................................................... 74 
16.10.2 
Early Termination or Suspension ..................................................................................... 74 
16.10.3 
Procedures for Termination or Suspension ..................................................................... 75 
17. 
References .................................................................................................................... 76 
18. 
Appendices .................................................................................................................... 77 
18.1 Informed Consent Template(s) ................................................................................................ 77 
18.2 Data Collection Elements (Electronic Case Report Forms) .......................................................... 77 
18.3 LINQTM for COPD Study Procedure Handbook ........................................................................... 77 
18.4 Participating Investigators and Institutions ............................................................................... 77 
18.5 IRB Committee List ................................................................................................................. 77 
18.6 Committees ........................................................................................................................... 77 
18.7 Labeling ................................................................................................................................. 77 
19. 
Version History .............................................................................................................. 78 

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1.  Administrative Information 
 
1.1 Sponsor Contact Information 
Medtronic contact information is provided below. This information is subject to change during the 
clinical study. Periodic updates to study contact information will be sent to the centers as needed. 
Table 1: Sponsor Contact Information 
 
Study Manager Contacts 
Worldwide clinical study leader/US contact 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXXXXXX 
Monitoring Contacts 
Worldwide monitoring leader/US contact 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXXXXXXXXX 
 
 
2.  Glossary 
 
 
Term 
Definition 
ADE 
Adverse device effect 
ADHF 
Acute Decompensated Heart Failure 
AE 
Adverse event 
AF 
Atrial Fibrillation 
ALLEVIATE-HF RAMware 
Investigational software downloaded to the LINQTM 
TruRhythm device in study subjects 
BCSS 
Breathlessness, Cough, and Sputum Scale 
BNP 
Brain natriuretic peptide 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 

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Term 
Definition 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case report form 
CRO 
Contract Research Organization 
CRT-D 
Cardiac resynchronization therapy-defibrillator 
CRT-P 
Cardiac resynchronization therapy-pacemaker 
CTA 
Clinical trial agreement 
CV 
Cardiovascular 
DD 
Device deficiency 
DMC 
Data Monitoring Committee 
EAC 
Event Adjudication Committee 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EGM 
Electrogram 
EP 
Electrophysiologist 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act 
FEV1 
Forced Respiratory Volume 
GCP 
Good Clinical Practice 
GOLD 
Global Initiative for Chronic Obstructive Lung Disease 
HF 
Heart failure 
HIPAA 
Health Insurance Portability and Accountability Act 
ICD 
Implantable cardioverter-defibrillator 

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Term 
Definition 
ICF 
Informed consent form 
ICM 
Insertable cardiac monitor 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IFU 
Indications for Use 
IPG 
Implantable pulse generator 
IRB 
Institutional Review Board 
LAR 
Legally authorized representative 
LINQ HF RAMware 
Investigational software downloaded to the LINQTM 
Pre-TruRhythm device in study subjects 
MCT 
Mobile cardiac telemetry 
MedDRA 
Medical Dictionary for Regulatory Activities 
MiD 
Monitoring in Dialysis 
NSR 
Non-significant Risk 
NT-proBNP 
N-terminal brain natriuretic peptide 
PRN 
‘pro re nata’ – as needed 
RDC 
Remote data capture 
RR 
Respiration rate 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SC 
Steering Committee 
SCD 
Sudden Cardiac Death 
SDN 
Software Distribution Network 

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Term 
Definition 
SGRQ 
St. George’s Respiratory Questionnaire 
UADE 
Unanticipated Adverse Device Effect 
UAE 
Unavoidable Adverse Event 
US 
United States 
USB 
Universal Serial Bus 
WO 
Work order 
 
3.  Synopsis 
 
 
Title 
Reveal LINQTM for COPD 
Clinical Study Type 
Prospective, non-randomized, multi-center, observational, pre-market clinical study. 
Product Name 
LINQTM Insertable Cardiac Monitor (ICM) System with either LINQ HF or ALLEVIATE-HF 
investigational RAMware download 
Sponsor / 
Local Sponsors 
Sponsor: 
Medtronic, Inc US 
8200 Coral Sea Street NE 
Mounds View, MN U.S.A. 55112 
Phone: 1-800-328-2518 
Indication under 
investigation 
The study is utilizing investigational RAMware, either LINQ HF OR ALLEVIATE-HF, that will be 
downloaded onto the subject’s market-released Medtronic Reveal LINQ ICM. The 
investigational RAMware enables the hardware to record and store additional sensor data. 
The market-released indication is provided below: 
The Reveal LINQ ICM is an insertable automatically activated and patient activated monitoring 
system that records subcutaneous ECG and is indicated in the following cases: 
• Patients with clinical syndromes or situations at increased risk of 
cardiac arrhythmias 
• Patients who experience transient symptoms such as dizziness, 
palpitation, syncope, and chest pain that may suggest a cardiac 
arrhythmia 
The device has not been tested specifically for pediatric use. 
Investigation 
Purpose 
The purpose of the LINQ™ for COPD study is to characterize Reveal LINQ™ derived data from 
patients with COPD by assessing the relationship between changes in LINQ™ derived data 

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with COPD exacerbation events. The study will also collect information regarding COPD 
related clinical events during the same period. 
Product Status 
*The LINQ™ device and the 2090 programmer are market-released, but once the 
investigational Software or RAMware is downloaded into the devices, they are considered 
investigational. 
**Subjects will receive the most current approved version of the investigational RAMware at 
the time of their device insertion. 
Study Objective 
The study objective is to characterize Reveal LINQ™ derived data from patients with COPD by 
assessing the relationship between changes in LINQ™ derived data with COPD events 
collected during the study. 
Study Design 
The Reveal LINQ™ for COPD study is a Non-significant Risk IDE, observational, non- 
randomized, multi-center, clinical study. The study is expected to be conducted at up to 10 
Model 
Number 
Component 
Manufacturer 
Investigational or 
Market-released 
LNQ11 
Reveal LINQ™ Insertable Cardiac 
Monitor 
Medtronic 
Market-Released* 
LNQ11 
Incision Tool 
Medtronic 
Market-Released 
LNQ11 
Insertion Tool 
Medtronic 
Market-Released 
SW026 
2090 Programmer 
Medtronic 
Market-Released* 
Not 
Applicable 
LINQ HF RAMware, Version 1.1 and 
subsequent versions as they are 
released** 
Medtronic 
Investigational 
Not 
Applicable 
LINQ HF Software, Rev 1.1 and 
subsequent versions as they are 
released 
Medtronic 
Investigational 
Not 
Applicable 
ALLEVIATE-HF RAMware, Version 
1.32 and subsequent versions as 
they are released** 
Medtronic 
Investigational 
ALVT22 
ALLEVIATE-HF Software, Rev 1.1 
and subsequent versions as they 
are released 
Medtronic 
Investigational 
PA96000 
Patient Assistant 
Medtronic 
Market-Released 
24950 
MyCareLink® Home Monitor 
Medtronic 
Market-Released 
DR220 
Holter 
NorthEast 
Monitoring, Inc. 
Market-Released 
IP-9260 
QS+CARE™ Bed Monitor 
EMFIT 
Market-Released 

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centers in the United States and up to 100 subjects will be enrolled, with no more than 20 
subjects enrolled per site. 
All enrolled subjects will be implanted with a Reveal LINQTM Insertable Cardiac Monitor (ICM) 
with either the investigational LINQ HF or ALLEVIATE-HF RAMware download, and will be 
followed until the last subjects’ 6-month follow-up visit is completed or until official study 
closure, defined as when Medtronic and/or regulatory requirements have been satisfied per 
the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, 
whichever occurs first. Accordingly, the expected total study duration is approximately 33 
months, representing approximately 26 months of patient enrollment, at least 6 months of 
follow-up with 1 month between enrollment and insertion. All LINQTM system and procedure- 
related adverse events (AEs), all serious adverse events (SAEs), all Pulmonary related AEs and 
all Cardiovascular related AEs will be collected throughout the study duration of a subject’s 
participation in the study, beginning at the time of informed consent. 
Sample Size 
The study may enroll approximately 100 subjects 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria 
• 
Patient is ≥ 45 years old 
• 
Patient (or patient’s legally authorized representative) is willing and able to provide 
written informed consent 
• 
Patient is willing and able to comply with the protocol, including follow-up visits, diary 
submissions and CareLink transmissions 
• 
FEV1 (post bronchodilator) ≤ 70% of predicted 
• 
Current or former smoker with lifetime cigarette consumption of > 10 pack-years 
• 
One COPD exacerbation in the previous 12 months requiring hospitalization, urgent care 
or emergency department visit for respiratory illness OR Two COPD exacerbations within 
the previous 12 months requiring antibiotics and/or corticosteroids for respiratory 
symptoms 
• 
The patient’s medical records must be accessible by the enrolling site over the follow-up 
period 
Exclusion Criteria 
• 
Less than 30 days from diagnosis of a COPD exacerbation as defined as taking antibiotics 
and/or corticosteroids for respiratory symptoms, hospitalization, urgent care or 
emergency department visit for respiratory illness. * 
• 
Less than 30 days from diagnosis of a HF event as defined as any cardiovascular-related 
(including hypervolemia) Health Care Utilizations (HCUs) for any one of the following 
events: Admission with primary diagnosis of HF or Intravenous HF therapy (e.g. IV 
diuretics/vasodilators) or ultrafiltration at any one of the following settings: Admission 
with secondary/tertiary diagnosis of HF, Emergency Department, Ambulance, 
Observation Unit, Urgent Care, or HF/Cardiology Clinic 
• 
Active respiratory infection being treated with antibiotics and/or corticosteroids 
• 
Class IV heart failure 
• 
Clinical diagnosis of unstable angina, bronchiectasis, or cystic fibrosis 

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• 
Any concomitant condition that might endanger the patient through participation in the 
study or interfere with study procedures, as assessed by the investigator 
• 
Patient is pregnant (all females of child-bearing potential must have a negative 
pregnancy test within 1 week of enrollment) 
• 
Patient is enrolled in another study that could confound the results of this study, without 
documented pre-approval from a Medtronic study manager 
• 
Patient has an existing or planned implantation of Medtronic IPG, ICD, CRT-D or CRT-P 
device in the near future 
• 
Patient has an existing and active insertable cardiac monitor, regardless of 
manufacturer.# 
• 
Concurrent disease with life expectancy less than 1 year 
* This exclusion criterion has been removed as documented in the Intended CIP deviation 
dated 13-OCT-2021 
# This exclusion criterion has been updated to “Patient has an active non-Medtronic 
insertable cardiac monitor” in the Intended CIP deviation dated 13-OCT-2021 
Study Procedures 
and Assessments 
When a patient or Legally authorized representative (LAR) and the principal investigator have 
signed, and dated the Patient Informed Consent Form, the patient is considered a subject 
enrolled in the study. Following consent, a baseline assessment will be completed, and 
subjects will undergo a Reveal LINQTM device insertion including either the LINQ HF or 
ALLEVIATE-HF investigational RAMware download within 30 calendar days of enrollment. All 
subjects will be provided with a MyCareLink Patient Monitor, enrolled in the Medtronic 
CareLink network, and instructed on how to set up their monitor to ensure automatic nightly 
transmission of their device data. Subjects will complete a weekly diary entry or when their 
symptoms change, comprising of the BCSS Questionnaire and documentation of any PRN 
medications. Additionally, subjects will complete telephone follow-up visits every three 
months post device insertion (visits may also be conducted in-person if desired). The optional 
in-office follow-up visit however can be conducted at any time during study participation, 
except within 30 days post insertion of the device. All enrolled subjects will be followed until 
study closure. Data collection and procedures are summarized below: 
Baseline: Informed consent, inclusion/exclusion assessment, medical history, subject 
demographics, SGRQ, Baseline Measurements, Medication Assessment, subject diary 
enrollment, Labs, Spirometry tests (pre and post bronchodilator), adverse events, study 
deviations 
LINQ Insertion Visit: LINQTM insertion, LINQ HF OR ALLEVIATE-HF RAMware download, device 
interrogation (save to media via USB), system and procedure information, adverse events, 
device deficiencies, study deviations 
Subject Diary (weekly): BCSS Questionnaire, PRN medication assessment 
Scheduled Phone Follow-up Visits (every 3 months): Medication assessment, adverse events, 
device deficiencies, study deviations 

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Scheduled In-office Follow-up Visit (optional): Baseline Measurements, medication 
assessment, device interrogation (save to media via USB) (pre and post visit procedures), 
spirometry tests with Holter, patient assistant activity, Chest x-ray, adverse events, device 
deficiencies, study deviations 
Study Exit Visit: Reason for exit, removal of LINQ HF or ALLEVIATE-HF RAMware from LINQTM 
device, device interrogation (save to media via USB), opting out of the subject diary, SGRQ, 
Medication assessment, labs, adverse events, device deficiencies, study deviations 
Additionally, up to 20 subjects will be asked to place an EMFIT monitor under their bed for the 
length of their study participation, with no more than 10 subjects per site. Furthermore, 
LINQTM device data will be collected bi-weekly via CareLink manual transmissions as well as 
system modifications and subject deaths will be collected. 
Safety Assessments 
All LINQTM system and procedure-related adverse events (AEs), all serious adverse events 
(SAEs), all Pulmonary related AEs and all Cardiovascular related AEs will be collected 
throughout the study duration of a subject’s participation in the study, beginning at the time 
of informed consent. An Event Adjudication Committee (EAC) will conduct a medical review of 
all adverse events classified by the investigator or Medtronic as Pulmonary related and all AEs 
with a fatal outcome. The EAC will consist of non-Medtronic employed physicians that are not 
participating investigators for the study. 
Statistics 
Since the study will be exploratory in nature and the study objectives are descriptive, no 
clinical endpoints will be developed. LINQ™ derived data will be summarized using descriptive 
statistics. Their relationship to COPD events (per EAC adjudication) will be evaluated by 
looking at the data before and after the occurrence of COPD events to identify potential 
patterns and signals. 
 
 
4.  Introduction 
 
4.1 Background 
The Reveal LINQTM system is an ICM manufactured by Medtronic, Inc. The LINQTM ICM is designed to 
automatically record the occurrence of ventricular tachyarrhythmias, bradyarrhythmias, pause, atrial 
tachyarrhythmias, and atrial fibrillation. While experiencing or immediately after a symptomatic event, 
the patient can activate the ICM to record their cardiac rhythm. 
The current indications are: 
US Indications: 
• 
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias. 
• 
Patients who experience transient symptoms such as dizziness, palpitation, syncope and chest 
pain that may suggest a cardiac arrhythmia. 

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Chronic Obstructive Pulmonary Disease (COPD) is progressive and currently incurable and refers to a 
collection of diseases that lead to the key feature of irreversible airflow limitation and breathing related 
problems. It is characterized by loss of lung elastic recoil, small airway remodeling, a progressive decline 
in FEV1 (Forced Expiratory Volume), decreased lung emptying, and static and dynamic hyperinflation1. 
Particulate exposure can lead to mucosal and glandular inflammation, increased mucous discharge and 
epithelial hyperplasia, and altered tissue repair in small conducting airways1. COPD is the third leading 
cause of death worldwide, with an estimated prevalence of 175 million1. Of those with COPD, 46% 
experienced at least one exacerbation within the previous year and 19% needed hospitalization2. 
Approximately 11% of those admitted for exacerbation die within 90 days, with half occurring during the 
hospitalization1. 35% of those admitted for exacerbation are readmitted within 90 days1. The financial 
burden of COPD is also evident, in that over $32 billion was spent for COPD care in the United States in 
2010 and it is expected to be close to $50 billion in 20203. More than 70% of the spending is related to 
hospitalizations in the COPD patients due to acute exacerbations. Most COPD exacerbations are caused 
by infection, with other major triggers including outdoor and indoor particulate air pollution and 
weather2. Confounding these metrics is the fact that there is much overlap in COPD with other 
concurrent disease. Approximately 1/3 of COPD patients die of cardiovascular disease and 1/3 of 
patients with cardiovascular disease have airflow limitation1. 
Reducing healthcare utilization associated with COPD patient management (i.e. short-term readmission 
and chronic disease management) is a critically important unmet need for patients, caregivers, and 
hospitals. Early detection, prevention, and treatment of COPD exacerbation would aim to reduce this 
high morbidity and cost. 
 
 
4.2 Purpose 
The ability to predict which patients will subsequently have an exacerbation for COPD using the 
traditional evaluation measures such as physical signs and symptoms is limited. Medical interventional 
methods currently may not identify patients early enough to prevent an exacerbation. To help reduce 
these exacerbations and improve disease management, sensors in a minimally invasive device can be 
used to identify factors that are associated with exacerbations. Thus, a solution to continuously monitor 
COPD patients at risk for acute exacerbations (GOLD stage C/D) in an ambulatory fashion to predict 
symptom worsening and provide timely remote intervention to prevent hospitalizations is an unmet 
clinical and economic need. Using sensors in a minimally invasive device like LINQTM to sense, predict 
and prevent COPD hospitalizations is the overarching objective of this project. As a first step, the LINQ- 
COPD study aims to collect sensor data to characterize the changes in these sensor data prior to COPD 
hospitalizations with the aim to develop a prediction algorithm that can identify when patients are risk 
and may benefit from a remote intervention. 
Prior studies have shown implantable device-measured diagnostics like intra-thoracic impedance,4 AF 
burden, heart rate metrics,5 respiration,6 and patient activity metrics7 can be used individually or in a 

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combined fashion to identify when patients are at risk for certain events. We hypothesize that these 
measurements made in the subcutaneous thoracic space may be sensitive enough to detect 
physiological changes associated with COPD. 
The use of implantable device features such as the OptiVol™ impedance algorithm is clinically useful in 
monitoring thoracic fluid status for pacemaker or ICDs and may be measured in the subcutaneous space. 
8 The Monitoring in Dialysis (MiD) study was conducted in renal failure patients implanted with a Reveal 
LINQ™ insertable cardiac monitor. The results indicated impedance trends upwards with fluid removal 
during dialysis sessions and downwards between dialysis sessions. Therefore, the preliminary data show 
that continuous impedance monitoring has a direct inverse relationship to patient thoracic fluid status in 
both a detailed analysis and long-term trending analysis.9 
Respiratory distress is the primary driver for HF hospitalization and detection of respiratory distress 
provides an early indicator of ADHF. Respiratory symptoms such as breathlessness and orthopnea are 
significantly related to increased mortality and associated with worse clinical outcomes.10,11 The NOTICE- 
HF study, patient ambulatory respiration rate (RR) was monitored using an ICD or CRT defibrillator.7 
Maximum, median, and minimum RR was significantly elevated prior to ADHF when compared to 
baseline. We hypothesize RR may be measured through subcutaneous thoracic space through the use 
of impedance or R-wave amplitude variations. 
The LINQ™ for COPD study will collect and characterize Reveal LINQ™ derived data from patients with 
COPD by assessing the relationship between changes in LINQ™ derived data with COPD exacerbation 
events. The study will also collect information regarding COPD related clinical events during the same 
period. 
 
5.  Objectives and/or Endpoints 
 
5.1 Objectives 
The study objective has been defined to characterize the Reveal LINQ™ derived data in patients with 
COPD related to COPD events. 
The study objective will be characterized, and a final study report will be completed after the final study 
exit. 
5.1.1 Primary Objective(s) 
• 
The primary objective is to characterize Reveal LINQ™ derived data from patients with COPD by 
assessing the relationship between changes in LINQ™ derived data with subsequent COPD events. 
 
COPD event is defined as an adverse event where the underlying COPD condition exacerbates 
beyond normal day-to-day variations, where an increase in dyspnea, cough, and/or sputum 

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production presents with acute onset and necessitates supplementing regular COPD medications 
with antibiotics for respiratory pathogens and/or steroids. 
 
6.  Study Design 
 
The LINQTM for COPD is a prospective, non-randomized, multi-center, observational, pre-market clinical 
study. The study may enroll up to 100 COPD subjects at up to 10 sites in the US, with no more than 20 
subjects enrolled per site. Study subjects will be followed until the last enrolled subject reaches their 6- 
month visit or until official study closure defined as when Medtronic and/or regulatory requirements 
have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory 
authority, whichever occurs first. . Accordingly, the expected total study duration is approximately 33 
months, representing approximately 26 months of patient enrollment, at least 6 months of follow-up 
with 1 month between enrollment and insertion. All Reveal LINQ™ system and procedure-related 
adverse events will be collected and reported per the study protocol. In addition, all SAEs, all Respiratory 
related AEs (regardless of seriousness) and all Cardiovascular related AEs (regardless of seriousness) will 
be collected and reported per study protocol. 
Following consent, subjects will undergo a baseline assessment followed by the LINQTM ICM device 
insertion procedure. Following insertion, subjects will complete a weekly diary entry, which includes 
answering the BCSS Questionnaire and recording any PRN medications. Additionally, subjects will 
complete telephone follow-up visits every three months post device insertion (visits may also be 
conducted in-person if desired). The optional in-office follow-up visit however can be conducted at any 
time during study participation, except within 30 days post insertion of the device. All enrolled subjects 
will be followed until study closure. A study flowchart is shown in Figure 1. 

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Figure 1: Study Flowchart 
 
 
 
6.1 Duration 
Subjects will be followed until the last enrolled subject reaches their 6-month visit or until official study 
closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical 
Investigation Plan (CIP) and/or by a decision by Medtronic or the applicable external parties (i.e. Ethics 
Committee (EC) Regulatory Authority) whichever occurs first. The estimated total study duration is 
approximately 33 months, representing a 26-month enrollment period, at least 6 months of follow-up 
per subject and up to 1 month between enrollment and insertion. 
6.2 Rationale 
As discussed in the Background section, reducing healthcare utilization associated with COPD patient 
management is a critically important unmet need for patients, caregivers, and hospitals. Early 
detection, prevention, and treatment of COPD exacerbation would aim to reduce this high morbidity 
and cost. The ability to predict which patients will subsequently have an exacerbation for COPD using 
the traditional evaluation measures such as physical signs and symptoms is limited, and there are few 
means for long-term monitoring of these signs and symptoms. Therefore, the purpose of this study is to 
collect long-term physiological recordings of heart rate, respiratory rate, temperature, and impedance in 

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relation to COPD exacerbations in a population with high likelihood to suffer exacerbations. The Reveal 
LINQTM is suitably positioned to collect such data in relation to COPD exacerbations in a non-obtrusive 
manner. The data collected will be used to develop methods for predicting and preventing COPD 
exacerbations, and ultimately to take aim at the unmet need of reducing healthcare utilization in COPD 
patient management. 
Safety will not be a primary focus of this study as 1) the study is only collecting observational data, 2) 
data collected will not be used to manage the treatment of subjects in the study, 3) data collection 
procedures other than those related to the LINQTM are not outside standard of care for COPD patients 
and 4) the safety profile of LINQTM is already well known.12 
6.3 Study Oversight 
Overall study Principal Investigator and Steering Committee member contact information is provided 
below. 
Table 2: Overall Study Principal Investigator Contact Information 
 
Name 
Contact Information 
XXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXX 
XXXXX 
XXXXXXXXXXXXXXXXXXX 
 
7.  Product Description 
 
7.1 General 
The Medtronic LINQTM ICM is an approved, programmable device that continuously monitors a patient’s 
electrocardiogram (ECG) and other physiological parameters. The device records cardiac information in 
response to automatically detected arrhythmias and patient activation. The LINQTM device is indicated in 
the following: 
US Indications: 
• 
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias. 
• 
Patients who experience transient symptoms such as dizziness, palpitation, syncope and chest 
pain that may suggest a cardiac arrhythmia. 
The study will be conducted using the components described in Table below. All components of the 
LINQTM system are manufactured by Medtronic, Inc. Instructions for use of the devices used in this study 
are provided within their respective manuals. 

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Table 3: Study Components 
 
Model 
Number 
Component 
Manufacturer 
Investigational or Market- 
released 
LNQ11 
Reveal LINQ™ Insertable Cardiac 
Monitor 
Medtronic 
Market-Released* 
LNQ11 
Incision Tool 
Medtronic 
Market-Released 
LNQ11 
Insertion Tool 
Medtronic 
Market-Released 
SW026 
2090 Programmer 
Medtronic 
Market-Released* 
Not Applicable LINQ HF RAMware, Version 1.1 and 
subsequent versions as they are 
released** 
Medtronic 
Investigational 
Not Applicable LINQ HF Software, Rev 1.1 and 
subsequent versions as they are 
released 
Medtronic 
Investigational 
Not Applicable ALLEVIATE-HF RAMware, Version 
1.32 and subsequent versions as 
they are released** 
Medtronic 
Investigational 
ALVT22 
ALLEVIATE-HF Software, Rev 1.1 
and subsequent versions as they 
are released 
Medtronic 
Investigational 
PA96000 
Patient Assistant 
Medtronic 
Market-Released 
24950 
MyCareLink® Home Monitor 
Medtronic 
Market-Released 
DR220 
Holter 
NorthEast Monitoring, Inc. Market-Released 
IP-9260 
QS+CARE™ Bed Monitor 
EMFIT 
Market-Released 
*The LINQTM device and the 2090 programmer are market-released, but once the investigational LINQ HF OR ALLEVIATE-HF 
programmer application and the investigational RAMware are downloaded onto the devices, they are considered 
investigational. 
** Subjects will receive the most current approved version of the investigational RAMware at the time of their device insertion. 
In the case that a new RAMware version is released during the course of the study, subjects previously receiving an older 
version of the RAMware will receive an upgrade to the new version. 
 
Descriptions of each component of the system are provided in the sections below. 
7.1.1 Reveal LINQTM Insertable Cardiac Monitor (ICM) 
The Reveal LINQTM ICM is a small, leadless device that is inserted under the skin, in the chest. A specific 
recommended location is provided within the product manual. The device uses two electrodes on the 
body of the device to continuously monitor the patient’s subcutaneous ECG. The device can store up to 
30 min of ECG recordings from the patient-activated episodes and up to 27 min of ECG recordings from 
the automatically detected arrhythmias. Documentation of episode occurrence will be retained. 

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Figure 2: Reveal LINQTM ICM 
 
 
7.1.2 Incision Tool 
The Incision Tool is designed to create an incision of repeatable width and depth with a single motion. It 
is composed of a blade, designed to make a repeatable incision, and handle, designed to ergonomically 
fit the clinician’s hand. The Reveal LINQ™ Incision Tool is intended to make the incision simple and 
repeatable. 
 
Figure 3: Incision Tool 
 
 
7.1.3 Insertion Tool 
The Insertion Tool delivers the device through the incision and into the subcutaneous tissue. The tool is 
designed to ensure the device is delivered into a tight pocket to maximize electrode contact with the 
surrounding tissue in a highly repeatable manner and is composed of two parts: a handle and a plunger. 
The Handle is composed of a “channel” section, used to hold the device and guide it during insertion, 
and a “Tunneler,” used to bluntly dissect an implant path for the device to travel down while being 
inserted. The plunger part is used to push the device out of the handle, through the incision, and along 
the insertion path created by the Tunneler to the final insertion location. 
The Reveal LINQ™ device will be loaded in the Insertion Tool and sterilely packaged with the Incision 
Tool. The Reveal LINQ™ Insertion Tool is used to create an implant path in the body and deliver the 
Reveal LINQ™ into the desired location. 

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Figure 4: Insertion Tool 
 
 
 
7.1.4 2090 Programmer 
The Medtronic CareLink® Programmer is used to program the Reveal LINQ™ ICM to detect arrhythmias 
with various pre-specified characteristics. In addition, the programmer allows the physician to view, 
save, and print the ECG records currently held within the Reveal LINQ™ ICM. 
 
 
Figure 5: Medtronic 2090 Programmer 
The Medtronic 2090 Programmer with the investigational software will be used to download the LINQ 
HF or ALLEVIATE-HF investigational RAMware onto the LINQ™ device. The investigational RAMware is 
required to activate additional sensors in the Reveal LINQ™ ICM. The software will be loaded onto the 
2090 programmers designated for clinical use only. The 2090 programmer with the investigational 
software will allow the ability to download and remove the RAMware onto and from the device. In 
addition, the 2090 programmer will be used during the study activities as well. 
7.1.5 Medtronic Investigational RAMware 
7.1.5.1 LINQ HF Investigational RAMware 
The LINQ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM 
(pre-TruRhythm) to allow for collection of device data needed for potential detection of early COPD 
events. In addition to the existing diagnostic data normally stored in the device, the LINQ HF 
investigational RAMware enables the Reveal LINQ™ hardware to collect and store additional sensor 
data, including impedance, temperature, activity, R-R interval, R-wave amplitude, posture change count 
(based on z-axis accelerometer values) and x, y, and z-axis accelerometer measurements. The device 

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will collect and store this data every 60 minutes for impedance, temperature, activity, R-wave amplitude 
and every 5 minutes for R-R intervals, posture change count, and x, y, and z-axis accelerometer values. 
In addition, impedance measurements are collected when the Patient Assistant is used. 
7.1.5.2 ALLEVIATE-HF Investigational RAMware 
The ALLEVIATE-HF investigational RAMware is required to activate sensors in the Reveal LINQ ICM with 
TruRhythm to allow for collection of device data needed for potential detection of early COPD events. In 
addition to the existing diagnostic data normally stored in the device, the ALLEVIATE-HF investigational 
RAMware enables the Reveal LINQ™ to record and store impedance, temperature, R-R interval, R-wave 
amplitude, x, y, and z-axis accelerometer measurements and posture change count periodically. The 
RAMware will calculate the respiration rate and will store daily impedance and respiration rate values. 
 
7.1.6 Patient Assistant 
The Patient Assistant is a hand-held, battery-operated telemetry device that enables the subject, on 
experiencing symptoms potentially indicative of a cardiac event, to manually trigger the LINQ™ ICM to 
collect and store an ECG record. 
The Reveal Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The 
Patient Assistant activates the data management feature in the Reveal LINQ™ ICM to initiate recording 
of cardiac event data in the implanted device memory. Additionally, the investigational RAMware 
enables the storage of a short segment of impedance signal when the Reveal Patient Assistant device is 
used. 
The subjects will be asked to press the Patient Assistant whenever they experience increased difficulty 
of breathing not related to an activity. In addition, the subjects may be asked to press the Patient 
Assistant device during the Optional In-Office F/U study visit. 
Figure 6: Patient Assistant 
 

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7.1.7 MyCareLink ® Home Monitor 
The MyCareLink® Home Monitor is a device that enables the device diagnostic data (which includes ECG 
data) to be transmitted directly from the implanted Reveal LINQ™ device to the Medtronic CareLink® 
Network for review by the physician. The additional data that is stored in the device by the 
investigational RAMware is also transmitted during a manual CareLink transmission but will not be 
available for review by site and or physician. 
Figure 7: MyCareLink Patient Monitor 
 
 
 
7.1.8 DR 220 Holter Monitor 
The NorthEast Monitoring, Inc. DR220 Digital Recorder is a Holter monitor that is commercially available 
and designed to facilitate the ambulatory cardiac monitoring of those subjects who may benefit from 
such monitoring on the order of a physician, including but not limited to those with complaints of 
palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge 
their current cardiac function, such as subjects who have recently received pacemakers. The DR220 
Digital Recorder is intended for use with Medtronic System-B compatible implantable pulse generators, 
implantable cardiac defibrillators, cardiac resynchronization therapy devices and implantable cardiac 
monitors. A Holter monitor is an external box used to record electrical heart signals from electrode 
patches attached to the skin (ECG) as well as from the cardiac device (EGM). There are no 
contraindications for the use of a DR220 Holter monitor. The Holter monitor will be used in accordance 
with its labeling. Only trained study personnel should apply the monitors. 
The data obtained by monitoring is not analyzed at the time of recording. After the recording is 
complete, the data must later be downloaded to a compatible NorthEast Monitoring, Inc. Holter analysis 
system to be analyzed. No personal information will be entered and collected by DR220 recorder. 
The DR220 Holter Recorder used in this study is a portable ECG device able to collect telemetry signals 
and marker channel information from any Medtronic device for up to 48 hours. The Holter Recorder has 
application for any subject with a Medtronic ICM. For the purposes of this study, the intended use of 
the Holter Recorder is to acutely uplink continuous impedance and ECG signals that will be collected by 
the investigational RAMware in the Holter mode. Since only the device data uplink feature of the Holter 
will be used in this study, the device antenna will only be used, and no ECG electrodes will be used. 

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Figure 8: DR220 Holter 
 
 
7.1.9 EMFIT QS + CARETM Bed Monitor 
The commercially available EMFIT QS+CARETM bed monitor is a real-time occupancy and movement 
activity monitor with health data tracking that is placed under the mattress. The monitor can track and 
record heart and breathing rate, heart rate variability, sleep time, movement activity, bed exits, sleep 
score and sleep stages. The data collected will be transmitted back to Medtronic through a cellular 
mobile data connection. Medtronic is requesting up to 20 subjects in the study to place the monitor 
under their mattress for the duration of their study participation, with no more than 10 subjects per 
site. The bed monitor will be used in accordance with its labeling. 
Figure 9: EMFIT QS+CARETM Bed Monitor 
 
 
7.2 Manufacturer 
All products used in this study are manufactured by Medtronic, Inc., with the exception of the DR220 
Holter Monitor and the EMFIT QS + CARETM Bed Monitor 

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7.3 Packaging 
Labelling for the LINQ HF and ALLEVIATE-HF investigational RAMware will be provided under separate 
cover. Labelling for all other market approved system components can be found with each package 
insert and/or are available on http://manuals.medtronic.com. 
The LINQ HF and ALLEVIATE-HF investigational programmer software will be distributed electronically 
through the Software Distribution Network (SDN), therefore physical media labeling is not required. 
Once the LINQ HF and ALLEVIATE-HF investigational software is installed on a CareLink 2090 
programmer, the programmer will be considered investigational and will be labeled accordingly. 
7.4 Intended Population 
The intended population for inclusion in the LINQTM for COPD study is COPD patients who are known to 
have frequent exacerbations (one requiring hospitalization, ED visit, or urgent care visit, or at least two 
others in the past year). The Reveal LINQTM device with investigational LINQ HF or ALLEVIATE-HF 
RAMware download will be used in study subjects to collect and characterize Reveal LINQTM derived data 
from patients with COPD by assessing the relationship between changes in LINQTM derived data with 
COPD exacerbation events. 
7.5 Product Use 
The market released Reveal LINQTM and investigational LINQ HF/ALLEVIATE-HF software and RAMware 
will be used in accordance with their respective product manuals, which are available under separate 
cover. 
7.6 Product Training Materials 
Clinicians implanting the market released Reveal LINQ ICM device in study subjects must have 
received prior training on the ICM insertion procedure, which may be documented via prior ICM 
insertion experience or documentation that training was provided. 
Prior to site activation or subsequent involvement in study activities, Medtronic will provide study 
specific training relevant and pertinent to the involvement of site personnel. 
7.7 Shipment of Study Components 
Medtronic will only allow shipment of the study device and components to the hospital or investigator 
when Medtronic has received all required documentation and has notified the site of readiness. 
Products shall be used in these centers only and according to the CIP. Clinical investigational devices and 
components that are used for purposes of the study only will be provided at no cost by Medtronic. 
Distribution of the study device and components to centers during the study will be managed by 
Medtronic. 
 
All investigational components must be stored in a secure location in which access is limited to 
authorized personnel only. 

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7.8 Product Receipt and Tracking 
Distribution of study components to study centers during the clinical study will be managed by 
Medtronic. All product must be stored in a secure location at the site. It is the responsibility of the 
investigator to correctly handle, store, and track the study products maintained at the site. Study 
components will be used only in the study according to the CIP. 
 
Product Distribution logs may be located in the database and will be used for tracking of products during 
and after the study. The logs must be updated when product is received, opened, implanted, explanted, 
disposed of or returned to Medtronic. The accountability log tracks product information including, but 
not limited to, date, model/serial number, and expiration date for received product, subject ID of 
implanted subject, date implanted, date explanted (if applicable), date returned to Medtronic and 
reason for return (if applicable), reason for and method of destruction/disposal for explanted 
components not returned to Medtronic (if applicable), and name of person responsible for return or 
destruction/disposal (if applicable). Medtronic will perform periodic reconciliation of investigational 
product to ensure traceability. 
 
The following products will be tracked on an accountability log: 
• 
Reveal LINQTM device 
• 
2090 Programmer with the Investigational Software 
• 
Patient Assistants provided to sites for use during in-office visits 
• 
Holter DR220 
• 
EMFIT QS+CARETM bed monitor 
 
The MyCareLink Patient Monitors and Patient Assistant devices provided to subjects as part of their 
Reveal LINQ ICM system will not be considered investigational in the study and will not be tracked on a 
product accountability eCRF. 
7.9 Product Storage 
It is the responsibility of the investigator to store the study specific components and study specific 
equipment in a secured and temperature-controlled area. The method of storage shall prevent the use 
of the study device and components for other applications. Opening sealed cases is forbidden for other 
than study use and must be reported to the Investigator and Sponsor upon detection. It is the 
responsibility of the investigator to correctly handle, store, and track the investigational products 
maintained at the study site. Investigational products will be used only in the clinical study according to 
the CIP. 
The 2090 programmers containing the LINQ HF or ALLEVIATE-HF investigational software will be labeled 
as investigational. 

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7.10 Product Return 
All explanted product should be returned to Medtronic for analysis according to local laws and 
regulations. If the products are explanted but not returned, a justification is required to be reported on 
the appropriate eCRF(s) and/or disposition log(s). The Product Distribution Logs must be updated for 
explanted devices. To receive a Returned Product Mailer Kit, please contact your local Medtronic 
personnel or Study Manager. All unused product must be returned to Medtronic upon study closure at 
the center. 
The Product Disposition Logs must be updated with the final device disposition. 
Table 4: Study Product Disposition 
 
Model 
Number 
Component 
Return to 
MDT at 
Center 
Closure 
Disposal after 
Each Use 
Investigational 
RAMware 
Removal 
Investigational 
Software 
Removal 
LNQ11 
Reveal LINQTM 
X 
(Explant 
Only) 
X 
(Study Exit) 
24950 
MyCareLink® Monitor 
X 
96000 
Patient Assistant* 
X 
2090 
2090 Programmer with 
Investigational 
Software 
X1 
X 
DR220 
Holter 
X 
IP-9260 
EMFIT QS+CARE™ Bed 
Monitor 
X 
1 If the 2090 programmer was supplied to the site for purposes of the study, the 2090 programmer should be returned to 
Medtronic. 
All product returns will be contingent on local laws and regulations. 
All Investigational Product will be labeled Investigational. 
*Patient Assistants that will be used at the sites are required to be returned to Medtronic at the end of 
the study. 
7.11 Product Accountability 
The following section details tracking of all clinical investigation study components. Study components 
will be distributed to a center only when Medtronic has received all required documentation and has 
notified the center of center activation. 

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7.11.1 
CareLink Programmer 
The 2090 Programmers used in the study are commercially available, however once the investigational 
Software is downloaded onto the 2090 Programmers in this study, the 2090 Programmer becomes 
investigational. The 2090 Programmer disposition logs will be located in the database and will be used 
for tracking of all programmers downloaded with the investigational software. When the investigational 
software is installed on or removed from the programmer(s), the programmer disposition log must be 
updated. 
7.11.2 
Reveal LINQ ICM 
The Reveal LINQ™ device used in this study are commercially available, however once the 
investigational RAMware is downloaded to the device, the device will be considered an investigational 
product. The investigational device will be tracked via device disposition logs in the database. When the 
investigational RAMware is installed on or removed from the device(s), these changes must be recorded 
on the applicable eCRF(s) (e.g. Insertion Procedure, Scheduled Follow-up or Study Exit eCRF). 
7.11.3 
Patient Assistant 
The Patient Assistant device(s) provided to sites for use during in-office study visits will be tracked 
on the Patient Assistant device accountability eCRF. Use of the Patient Assistant in the study is not 
considered investigational. Patient Assistant devices provided to subjects as part of their LINQ 
ICM system will not be tracked. 
7.11.4 
Holter DR220 
The Holter DR220 will be tracked on the DR220 Holter accountability eCRF. 
7.11.5 
EMFIT QS+CARETM bed monitor 
The EMFIT QS+CARETM bed monitor will be tracked on the EMFIT QS+CARETM bed monitor accountability 
eCRF. 
 
8.  Study Site Requirements 
 
8.1 Investigator/Investigation Site Selection 
All investigators or co-investigators managing the subject’s COPD must be qualified practitioners and 
experienced in the diagnosis and treatment of subjects with COPD. All implanting physicians must be 
experienced and/or trained in the handling of Reveal LINQTM ICM devices. 
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety and well-being of the subjects 
involved in the clinical investigation. 
The principal investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 

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• 
Be experienced in the field of application and training in the use of Reveal LINQTM ICM 
devices 
• 
Disclose potential conflicts of interest, including financial, that interfere with the conduct of 
the clinical investigation or interpretation of results 
• 
Be able to demonstrate that the proposed investigational study site: 
▪ 
Has the required number of eligible subjects needed within the recruitment period. 
▪ 
Has one or more qualified investigators, a qualified investigational study site team 
and adequate facilities for the foreseen duration of the clinical investigation. 
Study site personnel training will be completed and documented prior to participation in this study. 
8.2 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train study site personnel on 
the clinical investigation plan, on relevant standards and regulations (if needed), informed consent, and 
on data collection and reporting tools. If new members join the study site team, they will receive 
training on the applicable study requirements relevant to their role before contributing to the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following: 
• 
EC approval (and voting list, as required by local law) of the current version of the CIP and 
IC. 
• 
RA approval or notification (as required per local law) 
• 
Fully executed CTA 
• 
Financial disclosure (if applicable) 
• 
CV of investigators and key members of the investigation study site team (as required). The 
signature on the CV must be dated within 3 years prior to the date of activation of the study 
site. 
• 
Documentation of delegated tasks 
• 
Documentation of study training. 
• 
Additional requirements imposed by local regulations, the EC and RA shall be followed, if 
appropriate. 
In addition, all participating study site staff must be trained on the current version of the CIP as well as 
on the applicable study requirements depending on their role and must be delegated by the principal 
investigator to perform study related activities. 
Medtronic will provide each study site with documentation of study site/investigator readiness; this 
letter must be received prior to performing study related activities. 
8.3 Role of the Sponsor Representatives 
Sponsor representatives will provide support as required for the study under supervision of the Principle 
Investigator, including: 

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• 
Provide study training, including but not limited to training on the: CIP, Informed Consent 
process, data collection tools, and regulations 
• 
Technical support in installing/uninstalling the programmer software into/from the Programmer 
manually or via the SDN 
• 
Technical support at all in-office study visits under the supervision of the Principle Investigator, 
including device programming, but no data entry on eCRFs shall be performed by Medtronic 
personnel or their representatives at sites 
• 
A trained Medtronic representative may support a study investigator at the Insertion Visit by 
proactively providing support and feedback during the insertion procedure 
• 
Sponsor representatives may conduct monitoring and auditing activities for this study 
 
9.  Selection of Subjects 
 
9.1 Study Population 
The subject population for the LINQTM for COPD study is COPD patients who are known to have frequent 
exacerbations (one requiring hospitalization, ED visit, or urgent care visit, or at least two others in the 
past year). Inclusion and Exclusion criteria are listed below. 
9.2 Subject Enrollment 
Ethics Board/IRB and Medtronic approval of this Clinical Investigation Plan, the informed consent form 
and any other applicable documents must be obtained prior to enrolling subjects in the study. 
Medtronic will provide each study center with documentation of study center/investigator readiness; 
this letter must be received prior to subject enrollment. 
When a patient and the principal investigator or authorized designee, as required, have personally 
signed and dated the informed consent form, the patient is considered a subject enrolled in the study. 
Subjects must provide informed consent before any study related procedures occur. The date the 
subject signed the informed consent form and data protection authorization as required by local law 
must be documented in the subject’s medical records. 
9.3 Inclusion Criteria 
• 
Patient is ≥ 45 years old 
• 
Patient (or patient’s legally authorized representative) is willing and able to provide written 
informed consent 
• 
Patient is willing and able to comply with the protocol, including follow-up visits, diary submissions 
and CareLink transmissions 
• 
FEV1 (post bronchodilator) ≤ 70% of predicted 
• 
Current or former smoker with lifetime cigarette consumption of > 10 pack-years 

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• 
One COPD exacerbation in the previous 12 months requiring hospitalization, urgent care or 
emergency department visit for respiratory illness OR Two COPD exacerbations within the previous 
12 months requiring antibiotics and/or corticosteroids for respiratory symptoms 
• 
The patient’s medical records must be accessible by the enrolling site over the follow-up period 
9.4 Exclusion Criteria 
• 
Less than 30 days from diagnosis of a COPD exacerbation as defined as taking antibiotics and/or 
corticosteroids for respiratory symptoms, hospitalization, urgent care or emergency department 
visit for respiratory illness. * 
• 
Less than 30 days from diagnosis of a HF event as defined as any cardiovascular-related (including 
hypervolemia) Health Care Utilizations (HCUs) for any one of the following events: Admission with 
primary diagnosis of HF or Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration 
at any one of the following settings: Admission with secondary/tertiary diagnosis of HF, Emergency 
Department, Ambulance, Observation Unit, Urgent Care, or HF/Cardiology Clinic 
• 
Active respiratory infection being treated with antibiotics and/or corticosteroids 
• 
Class IV heart failure 
• 
Clinical diagnosis of unstable angina, bronchiectasis, or cystic fibrosis 
• 
Any concomitant condition that might endanger the patient through participation in the study or 
interfere with study procedures, as assessed by the investigator 
• 
Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test 
within 1 week of enrollment) 
• 
Patient is enrolled in another study that could confound the results of this study, without 
documented pre-approval from a Medtronic study manager 
• 
Patient has an existing or planned implantation of Medtronic IPG, ICD, CRT-D or CRT-P device in the 
near future 
• 
Patient has an existing and active insertable cardiac monitor, regardless of manufacturer # 
• 
Concurrent disease with life expectancy less than 1 year 
 
* This exclusion criterion has been removed as documented in the Intended CIP deviation dated 13- 
OCT-2021 
# This exclusion criterion has been updated to “Patient has an active non-Medtronic insertable cardiac 
monitor” in the Intended CIP deviation dated 13-OCT-2021 
 
10. 
Study Procedures 
 
10.1 Schedule of Events 
A patient will be considered enrolled in the study once they sign and date the Informed Consent. The 
subjects will be followed via trimonthly phone calls and potentially at one in-office visit at some point 
during study participation. In addition, the subjects will be completing their weekly diary submissions 
and bi-weekly manual device transmissions. 

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10.2 Data Collection 
The requirements for data collection and study procedures by visit are summarized in Table 5 below. 
Table 5: Data Collection and Study Procedure Requirements at Subject Visits 
 
STUDY PROCEDURE 
Baseline 
LINQTM 
Insertion 
Weekly 
Subject 
F/U Phone 
Call (every 
3 months) 
In Office 
F/U 
(optional) 
Study Exit 
Patient Informed Consent 
X 
Inclusion/Exclusion Assessment 
X 
Medical History 
X 
Demographics 
X 
SGRQ (St. George’s Respiratory Questionnaire) 
X 
X 
BCSS (Breathlessness, Coughing and Sputum Scale) 
X 
Baseline Measurements 
X 
X 
Medication Assessment 
X 
X 
X 
X 
PRN Medication Assessment 
X 
Patient Assistant Activity 
X 
Laboratory results 
X 
X 
Final system configuration 
X 
Insertion procedure information 
X 
LINQ HF or ALLEVIATE-HF RAMware download onto LINQ™ 
device 
X 
Device Data Interrogation (Save to media via USB) 
X 
X 
X 
Standard Forced Spirometry Test (pre and post bronchodilator) 
X 
Standard Forced Spirometry Test (pre and post bronchodilator) 
while wearing Holter 
X 
Spirometry Test for Tidal Volume while wearing Holter 
X 
Chest X-ray 
X 
LINQ HF or ALLEVIATE-HF RAMware removal from LINQ™ 
device and optional explant 
X 
Adverse Events (including AEs with a fatal outcome) 
As they occur 
Device Deficiency 
System Modification 
Study Deviations 

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10.3 Scheduled Follow-up Visit Windows 
Because the study is estimated to be completed in approximately 33 months (includes approximately 26 
months of enrollment and 6 months of follow-up from the last enrolled subject and up to 1 month 
between enrollment and insertion), window dates are provided for 33 months. If follow-up phone calls 
need to continue beyond 33 months, the windows will continue at 90-day intervals with ±14-day 
windows. Should a subject miss a visit or the visit fall outside the pre-specified window, a study 
deviation must be reported, and the original follow-up schedule maintained for subsequent visits. Data 
analyses include follow-up visits, regardless of whether the visit occurs within the window. Therefore, a 
late visit is preferred over a missed visit but must be accompanied by a deviation. 
Table 6: Scheduled Visit Windows 
 
Study Follow- 
up Visit 
Window 
(Calculated days post LINQ™ device insertion) 
Window Start 
(# of days) 
Target 
(# of days) 
Window End 
(# of days) 
3-Month 
76 
90 
104 
6-Month 
166 
180 
194 
9-Month 
256 
270 
284 
12-Month 
346 
360 
374 
15-Month 
436 
450 
464 
18-Month 
526 
540 
554 
21-Month 
616 
630 
644 
24-Month 
706 
720 
734 
27-Month 
796 
810 
824 
31-Month 
886 
900 
924 
 
10.4 Subject Screening 
Subjects will be screened to ensure they meet all the inclusion criteria and none of the exclusion criteria 
prior to study enrollment. The subject will be considered enrolled after both the subject and the 
investigator (or authorized designee as required by the informed consent form [ICF]) have each 
personally signed and dated the ICF. 

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10.5 Subject Consent 
The ICF is defined as a legally effective documented confirmation of a subject’s voluntary agreement to 
participate in a particular clinical study after information has been given to the subject on all aspects of 
the clinical study that are relevant to the subject’s decision to participate. This process includes 
obtaining an ICF and an Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language as required by law that has been approved by the study site’s 
Institutional Review Board/Ethics Committee (IRB/EC) and signed and dated by the subject. 
Investigators shall consider all subjects who meet eligibility requirements for study participation to avoid 
any bias in the subject population. Prior to enrolling subjects, approval of the CIP, ICF, and any other 
written study information to be provided to the subjects must have been obtained from each site’s 
IRB/EC. The document(s) must be controlled (i.e. versioned and dated) to ensure it is clear which 
version(s) were approved by the IRB/EC. Any adaptation of the sample ICF must be reviewed and 
approved by Medtronic and the IRB/EC reviewing the application prior to enrolling the subject. 
The investigator must notify the subject of any significant new findings about the study that become 
available during the study which are pertinent to the safety and well-being of the subject, as this could 
impact a subject’s willingness to participate in the study. If relevant, approval may be requested from 
subjects to confirm their continued participation. 
Refer to Section 18.1 for the informed consent form template. 
Prior to initiation of any study-specific procedures, informed consent must be obtained from the 
subject. Likewise, privacy or health information protection regulation may require subjects to sign 
additional forms to authorize sites to submit subject information to the study sponsor. The informed 
consent process must be conducted by the principal investigator or his/her authorized designee, and the 
ICF and Authorization to Use and Disclose Personal Health Information/Research Authorization/other 
privacy language as required by law must be given to the subject in a language, he/she is able to read 
and understand. The process of obtaining informed consent must be conducted without using coercion 
or undue improper influence on or inducement of the subject to participate by the investigator or other 
site personnel. The informed consent process shall not waive or appear to waive subject’s legal rights. 
The language used shall be as non-technical as possible and must be understandable to the subject and 
the impartial witness, where applicable. 
The subject must have ample time and opportunity to read and understand the ICF, to inquire about 
details of the study, and to decide whether to participate in the clinical study. All questions about the 
study should be answered to the satisfaction of the subject. 
When the subject decides to participate in the clinical study, the ICF must be signed and personally 
dated by the subject acknowledging that their participation is voluntary and signed and personally dated 
by the investigator or authorized designee as required by the ICF. If applicable, the witness shall also 

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sign and personally date the ICF to attest that the information in the ICF was accurately explained and 
clearly understood by the subject, and that informed consent was freely given. 
A copy of the ICF and the Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language, signed and dated as required by law, must be provided to the 
subject. 
If informed consent is obtained the same day the subject begins participating in study-related 
procedures, it must be documented in the subject’s case history that consent was obtained prior to 
participation in any study-related procedures. It is best practice for the informed consent process to be 
documented in the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, a witnessed (impartial third party) informed consent 
will be allowed. In this situation, an independent witness must be present throughout the informed 
consent process. The written informed consent form and any other information shall be read aloud and 
explained to the prospective subject. The subject should “make his/her mark” (sign or otherwise 
physically mark the document so as to indicate consent) on the ICF as well. The witness must also sign 
and personally date the ICF attesting that the information was accurately explained, and that informed 
consent was freely given. Detailed documentation of the consent process must be recorded in the 
subject’s case history. The ICF should document a supervised oral process was used for communication 
with the prospective subject and the specific means by which the prospective subject communicated 
agreement to participate in the study. 
The ICF and Authorization to Use and Disclose Personal Health information/Research 
Authorization/other privacy language as required by law must be available for monitoring and auditing. 
Any Medtronic Field personnel who support the Reveal LINQTM ICM insertion procedure must be able to 
review the subject’s original signed and dated ICF and verify its completeness prior to proceeding with 
the insertion. In the event the Medtronic Field personnel identify informed consent as being 
incomplete, the study procedure will not be allowed to occur until the consent of the subject can be 
adequately and appropriately obtained. 
10.6 Enrollment 
A subject is considered enrolled when the consent process has been finalized. The date the subject (or 
the subject’s authorized/designated representative or guardian) signed the IC and Data Protection 
Authorization, as required by law, must be documented in the subject’s medical records. Enrollment can 
be a stand-alone visit or can occur on the same day as the baseline visit. Once consent is obtained, 
report adverse events/deaths, study deviations and subject exits as they occur. 
10.7 Baseline 
Following subject enrollment, a baseline assessment will be performed. The baseline visit can be a 
standalone visit or can be performed on the same day as the LINQ™ ICM insertion but prior to the 
insertion procedure. 

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The following information is required to be collected at the baseline visit: 
• 
Inclusion/exclusion criteria assessment (including pregnancy test if the subject is of 
childbearing potential) 
• 
Medical history 
• 
Medication assessment 
• 
Demographics 
• 
St. George’s Respiratory Questionnaire 
• 
Baseline Measurements 
• 
Standard Forced Spirometry assessment (pre and post bronchodilator) (if it hasn’t been done in 
the past 6 months) 
• 
Lab Results: Creatinine, Brain natriuretic peptide (BNP) OR N-terminal brain natriuretic peptide 
(NT-proBNP), White Blood Cells, and Eosinophils 
• 
Study deviations 
• 
Adverse events 
10.8 Implant 
The LINQTM insertion procedure must occur within 30 days of enrollment or baseline assessment and will 
be performed in accordance with the Medtronic Reveal LINQ™ implant instructions. The recommended 
implant locations are located in Figure 10 below. Physicians should follow the implant manuals when 
performing the Reveal LINQ™ implant. 
 
 
Figure 10: Recommended Insertion Locations 
After the Reveal LINQ™ device is inserted, the LINQ HF or ALLEVIATE-HF investigational RAMware will be 
downloaded to the device via the 2090 programmer depending on the type of the Reveal LINQ device 
(see Table 7 below). 

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Table 7. Investigational RAMware compatibility 
 
Reveal LINQ (pre-TruRhythm) 
Reveal LINQ with TruRhythm 
LINQ HF RAMware 
ALLEVIATE-HF RAMware 
 
The following procedures and data collection are required at the insertion visit: 
• 
LINQTM insertion procedure 
• 
LINQTM system and procedure information 
• 
LINQ HF or ALLEVIATE-HF Investigational RAMware download 
• 
Device Interrogation (save to media via USB) 
• 
Adverse events (if applicable) 
• 
Device deficiencies (if applicable) 
• 
Study deviations (if applicable) 
 
 
10.8.1 
Device Programming Requirements 
Once the LINQ™ device is inserted into the subject, the physician is recommended to choose "AF 
management.” This will automatically program the device to the nominal settings for the different 
detectors. 
10.9 EMFIT-QS+CARE™ Bed Monitor 
Up to 20 subjects will be asked to place the EMFIT bed monitor under their mattress at home during 
their participation in the study, with no more than 10 subjects per site. This sensor is a contact-free 
health monitor using ballistocardiography to measure heart beats and breaths to provide a detailed 
description of sleep quality. Data collected by the monitor will be transmitted with the built-in cellular 
connection to Medtronic. Please refer to Section 18.3 for more details on the product. 
10.10 
Weekly Subject Diary 
Subjects will complete diary submissions at least once a week or when their COPD symptoms change, 
which can be more often than once per week. The diary comprises of the Breathlessness, Coughing and 
Sputum Scale Questionnaire (BCSS) and PRN medication tracking. The subject will receive instructions on 
how to complete the weekly diary, refer to Section 18.3 for more details. 
The diary data will be reviewed alongside the CRF and LINQ™ device data to track potential COPD 
events. The subject diary data will not be reviewed for any reportable AEs since all pertinent AEs will be 
formally collected at the scheduled follow up visits. 

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10.11 
Bi-Weekly CareLink Transmissions 
Subjects will be provided with a MyCareLink Patient Monitor and enrolled in the Medtronic CareLink 
network, and will be instructed on how to set up their monitor to support automatic nightly 
transmission of their device data. In addition, subjects are required to perform a manual device 
transmission bi-weekly (every 14 days) from the time they are enrolled in the study until they are exited 
from the study. This transmission is critical as data collected by the investigational RAMware will be 
overwritten if not manually transmitted within 32 days. 
As described above, the subjects are required to complete a bi-weekly transmission. A report will be 
made available to the site identifying subjects who have missed their manual transmission. 
A monthly study deviation will be required if 2 straight bi-weekly transmissions are missed, unless a 
device interrogation file for an interrogation occurring within the required timeframe is provided to 
Medtronic. 
10.12 
Scheduled Follow-up Visits 
10.12.1 
Phone Follow-up Visit (every 3 months) 
Subjects will complete telephone follow-up visits every three months post device insertion. These visits 
may also be conducted in-person if desired, e.g. in the case the subject is already in-office for another 
reason. The following information is required to be collected at these visits: 
• 
Manual data transmission reminder 
• 
Medications Assessment 
• 
Adverse Events 
• 
Device deficiencies 
• 
Study deviations 
• 
System modification 
10.12.2 
In-Office Follow-up Visit (optional) 
The optional in-office follow-up visit can be conducted at any time during study participation, except 
within 30 days post insertion of the device to collect baseline measurement information and complete a 
variety of tests as outlined below. Although, this in-office visit is optional, it is requested that at least 30 
subjects complete this visit. 
The following information is required to be collected at the In-Office scheduled follow-up visit: 
• 
Baseline measurements 
• 
Medications Assessment 
• 
Initial device interrogation (pre visit procedures) (save to media via USB) 
• 
Spirometry test for Tidal Volume with breathing maneuvers 
o DR220 Holter recommended to be used during test 

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• 
Standard Forced Spirometry test (pre and post bronchodilator) 
o DR220 Holter recommended to be used during test 
• 
Final device interrogation (post visit procedures) (save to media via USB) 
• 
Chest X-ray (if no previous PA or AP and Lateral chest x-ray with LINQ device in image) 
• 
Adverse events (if applicable) 
• 
Device Deficiencies (if applicable) 
• 
Study Deviations (if applicable) 
• 
System Modifications (if applicable) 
10.13 
Spirometry Test 
10.13.1 
Assessment of Tidal Volume 
A spirometry test for tidal volume will be completed twice at the optional in-office visit accompanied 
with breathing maneuvers and with the Holter applied. Oftentimes, one of these tests is referred to as 
the Maximum Voluntary Ventilation (MVV) Test, however in this study, it will be performed with 
specified breathing maneuvers outlined in Figure 11 below. In addition, a Holter will be recommended 
Figure 11. Tidal Volume Spirometry Assessment Workflow 
 

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to be worn during the test. The subjects may also be asked to press the Patient Assistant device during 
the assessment. Refer to section 18.3 for more details. 
 
 
10.13.2 
Standard Forced Spirometry Test 
A standard forced spirometry test will be completed at the baseline and the optional in-office visit. If the 
subject has had the test completed in the past 6 months prior to Baseline, then the test does not need 
to be repeated (data from the prior spirometry test can be input in Baseline CRF). The forced spirometry 
assessment will consist of a test pre bronchodilator and post bronchodilator. It is requested of the site 
to record at most the first eight tries of each test (pre and post bronchodilator). 
At the optional in-office visit, a Holter will be recommended to be worn during the test. In addition, the 
subjects may be asked to press the Patient Assistant device during the assessment. Refer to section 18.3 
for more details. 
10.14 
Chest X-ray 
A chest X-ray (i.e. PA or AP and Lateral) displaying the location of the LINQ device must be collected. If 
the subject has not had a prior chest X-ray with the LINQ device in image, then a chest X-ray will be 
completed (can occur any time after LINQ insertion but must occur before study exit). 
10.15 
Holter 
Subjects may be asked to have a Holter placed to collect some additional information from the LINQ™ 
device. The DR220 Holter Recorder used in this study is a portable ECG device able to collect 
continuously telemetered signals from any Medtronic device for up to 48 hours. The Holter Recorder 
has application for any subject with a Medtronic ICM. For the purposes of this study, the intended use 
of the Holter Recorder is to acutely uplink continuous impedance and ECG signals that will be collected 
by the investigational RAMware in the Holter mode. The intended use of Holter mode is for a short 
duration of 30 minutes at each spirometry test at the optional in-office visit, or else the Holter does not 
store any data. 
Since only the device data uplink feature of the Holter will be used in this study, the device antenna will 
only be used, and no ECG electrodes will be used. Please refer to Section 18.3 for more details. 
10.16 
Device Interrogation 
For all visits occurring in the office, a full “interrogate all” final device interrogation file (.pdd) must be 
obtained and saved in a digital format (USB). The original file must be stored at the site and a copy sent 
to Medtronic. It is recommended that data are not cleared during any interrogation. The interrogation 
should be conducted at the end of the visit. 
10.17 
System Modification 
A system modification will be reported in the event the device requires invasive modification (e.g., 
device explant (other than at study exit), device reposition). In the event of a system modification, the 

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follow-up schedule for the subject will remain unchanged. For a system modification the following 
activities are required: 
• 
Complete the System Modification eCRF 
• 
Device interrogation (media/USB) 
• 
Adverse events (if applicable) 
• 
Device Deficiencies (if applicable) 
• 
Study Deviations (if applicable) 
If the device is taken out of service (e.g. explanted) and a replacement will not be implanted, or the 
replacement is not a study approved device, the subject must be exited from the study after all device 
and/or procedure related AEs have been resolved or remain unresolved with no further action planned. 
All explanted product (device) should be returned to Medtronic for analysis when permissible by local 
laws and regulations. See Section 7.6 for final product disposition details. 
10.18 
Medications Assessment 
The name, dose, frequency and route of all medications will be collected at all visits. Changes to 
medications will be captured on the Medication Log eCRF. 
There are no medications that are required for this study although some medications may be 
administered in treating specific conditions at the discretion of the physician. The only medications that 
are excluded from use during this study are investigational. 
10.19 
Assessment of Safety 
All LINQTM system and procedure related adverse events (AEs), all serious adverse events (SAEs), all 
Pulmonary related AEs and all Cardiovascular related AEs will be collected throughout the duration of a 
subject’s participation in the study, beginning at the time of informed consent. Additionally, any device 
deficiencies related to the LINQTM system will be collected. Adverse events and device deficiencies will 
be reported to Medtronic via completion of eCRFs. See section 12.0 for additional details. 
LINQTM system and procedure related AEs reported in the study will be summarized as an ancillary 
objective. Additionally, reported device deficiencies will be summarized. 
10.20 
Review of Data Recorded by the Reveal LINQTMDevice 
Reveal LINQ™ data derived from the investigational RAMware will not be viewable to the site. The 
standard arrhythmia data from the LINQ™ device will be viewable via CareLink. 
10.21 
Recording Data 
Subject data will be collected on electronic case report forms (eCRFs) via a web-based remote data 
capture (RDC) system. The investigator must ensure accuracy, completeness and timeliness of the data 

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reported in the eCRFs. Only authorized persons can complete and sign e-CRFs, as specified on the 
Delegated Tasks List included in the Investigator Site File. 
Procedures in the CIP require source documentation. Source documents, which may include worksheets 
and subject medical records, must be created and maintained by the investigational site team. Subject 
records must be clearly marked to indicate that subject participates in the study. When copies or 
printouts of source documents are made, these must be signed and dated by a member of the 
investigational site team with a statement that it is a true reproduction of the original source document. 
Device data from transmissions will be uploaded to secure servers. Media/USB data collected at office 
visits will be sent to Medtronic. Upon receipt, device data will be maintained with databases and 
retrieved for analysis and reporting. 
Refer to section 16.2 for additional detail regarding data management for the study. 
10.22 
Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement. If an infringement remains unresolved, multiple 
deviations need not be completed. 
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, 
or makes a conscious decision to deviate. Prior approval is not required when a deviation is necessary 
to protect the safety, right or well-being of a subject in an emergency or in unforeseen situations 
beyond the investigator’s control (e.g. subject failure to attend scheduled follow-up visits, inadvertent 
loss of data due to computer malfunction, inability to perform required procedures due to subject 
illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis). However, 
prior approval from Medtronic is required for such situations. 
All study deviations must be reported on the study deviation e-CRF regardless of whether medically 
justifiable, pre-approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an 
emergency. The deviation description and reason for deviation must be recorded. Multiple deviations 
of the same type at the same visit may be reported on one e-CRF. 
In the event the deviation involves a failure to obtain a subject’s consent or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB/EC as well as 
Medtronic within five (5) working days. Reporting of all other study deviations must comply with IRB/EC 
policies and/or local laws and/or regulatory agency requirements and must be reported to Medtronic as 
soon as possible upon the center becoming aware of the deviation. Refer to Table 12 for geography 

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specific deviation reporting requirements and timeframes for reporting to Medtronic and/or regulatory 
bodies. 
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the Clinical Investigation Plan, conduct 
additional training, terminate the investigation). Repetitive or serious investigator compliance issues 
may result in initiation of a corrective action plan with the investigator and site, and in some cases, 
necessitate suspending enrollment until the problem is resolved or ultimately terminating the 
investigator’s participation in the study. Medtronic will provide site-specific reports to investigators 
summarizing information on deviations that occurred at the investigational site on a periodic basis. 
10.23 
Subject Exit, Withdrawal or Discontinuation 
10.23.1 
Study Exit 
Study exit is defined as the moment when a subject officially stops participating in the study. Subjects 
will be considered exited upon completion of the study exit e-CRF. Prior to exiting a subject from the 
study, it is recommended to follow the subject until any ongoing AEs related to the Reveal LINQ™ 
system or procedure are classified by the investigator, as resolved. The date and reason for subject exit 
must be reported to Medtronic at the earliest opportunity via eCRF. Exited subjects will not be replaced. 
Upon exiting from the study, no further study data will be collected, or study visits will occur for the 
subject. All data available through the time of the subject’s exit will be used for analysis. Subjects are 
urged to remain in the study as long as possible but may be exited from the study for any of the 
following situations: 
• 
Subject did not meet inclusion/exclusion criteria and was not inserted with a LINQTM device 
• 
LINQTM ICM explanted and not replaced with a new LINQTM ICM (e.g. diagnosis determined, 
suspected infection, subject request, physician determination) 
• 
Subject chooses to withdraw (e.g., consent withdrawal, relocation to another geographic 
location) 
• 
Investigator chooses to withdraw a subject (e.g., medically justified, inclusion/exclusion criteria 
not met, failure of subject to maintain adequate study compliance) 
• 
Implant attempted, however no Reveal LINQTM was implanted 
• 
Subject lost to follow-up 
• 
Death 
• 
Study completion or termination 
The following information/procedure is to be collected/performed at study exit: 
• 
Date of exit 
• 
Reason for exit 
• 
Medications Assessment 
• 
St. George’s Respiratory Questionnaire 

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• 
Laboratory results: Creatinine, Brain natriuretic peptide (BNP) OR N- terminal brain 
natriuretic peptide (NT-proBNP), White blood cells, Eosinophils 
• 
Initial Device Interrogation (save to media via USB) (prior to removal) 
• 
Removal of the investigational RAMware from the LINQTM device 
• 
Opting out of the subject diary 
• 
Post Device interrogation (save to media via USB) (post removal) 
• 
Adverse events 
• 
Device deficiencies 
• 
Study deviations 
10.23.2 
Study Completed 
All subjects will be exited from the study when the last subject’s 6-month follow-up visit is completed or 
until official study closure, defined as when Medtronic and/or regulatory requirements have been 
satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, 
whichever occurs first. Subjects will be provided standard medical care by their physician after their 
study participation ends. 
10.23.3 
Lost to Follow-up 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded. In addition, follow the regulations set forth by the governing IRB/EC. 
10.23.4 
Subject Chooses to Exit (i.e. Revokes Consent) 
A subject can withdraw from the study at any time. If the subject wishes to exit from the study (i.e. the 
subject revokes consent), the study site is required to document the reason for exit on the Exit CRF. In 
addition, study sites shall follow the regulations set forth by the governing EC. If possible, the following 
data should be collected prior to subject withdrawal: 
• 
Reason for exit 
10.23.5 
Investigator Withdraws Subject 
No subjects should be withdrawn by investigators unless compelling medical justification is present. It is 
recommended investigators discuss any withdrawals with the study team prior to withdrawing subjects. 
If an Investigator Withdrawal is necessary, the following data should be collected prior to subject 
withdrawal if possible: 
• 
Reason for subject withdrawal 
10.23.6 
Conditional Disengagement 
After a subject is enrolled/randomized every effort should be made to keep the subject in the study. 
However, it is recognized that there are circumstances where limited data may be collected, or study 
exit will need to occur. In these cases we will consider either modified data collection requirements 
where subjects may conditionally disengage in study procedures but data from the subject can still be 

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collected because the subject has not revoked consent, or exit when study participation is completely 
ended. In randomized subjects, modified data collection is always preferred over exit. 
Subjects may be conditionally disengaged from study procedures for any of the following reasons: 
• 
Subject chooses to disengage (e.g., follow-up schedule cannot be adhered to, study 
burden too large, relocation to another geographic location but telephone follow-up still 
acceptable) 
• 
Investigator deems conditional disengagement necessary (e.g. medically justified) 
If the subject wishes to disengage from the study, or the investigator deems it necessary, the study site 
is required to document the reason. Prior approval from the study team is required and a Limited Data 
Collection CRF needs to be completed. Data collection requirements no longer apply, but study sites are 
encouraged to collect as much data as possible on the regular CRFs. 
 
11. 
Risks and Benefits 
 
11.1 Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the lifecycle of a 
product, from the business analysis phase through development, market release, and post-market 
surveillance. The risk analysis process for the LINQ™ for COPD study is being performed in accordance 
with ISO 14971, and ensures that the level of residual risk is reduced to as low as possible prior to 
starting the clinical study. 
There are potential risks and side effects associated with a Reveal LINQ™ device implant and explant 
procedures: 
• 
Allergic reaction or device rejection phenomena including local tissue reaction 
• 
Excessive device migration (internal pocket device movement as well as device externalization) 
• 
Pocket infection 
• 
Erosion through the skin 
• 
Tissue / vascular trauma 
Possible additional risks for participating in this study include the following (although others are 
possible): 
• 
The Reveal LINQ™ device with investigational RAMware download is investigational and may be 
no more effective or less effective than a commercially available Reveal LINQ™ device system. 
• 
There may be stimulation effects from the impedance measurements being taken across the 
Reveal LINQ™ device electrodes. The amount of current injected as part of the impedance 
measurements has been minimized to very low levels to prevent patient harm. 
• 
The investigational RAMware feature set will cause current drain on the Reveal LINQ™ ICM 
device battery. Risk control measures have been implemented and the current projected 
longevity of a LINQ™ device with investigational RAMware shows a 5 month decrease in average 

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projected service life compared to a LINQ™ device without the RAMware. The exact service life 
of the LINQ™ device will vary depending on each subject’s use. 
• 
There may be undesired device interactions with the investigational RAMware, potentially 
resulting in loss of or inaccurate Reveal LINQ™ data, and/or premature explant. Once the 
investigational RAMware feature set is executed, periodic data integrity checks are in place to 
ensure correct functionality. 
• 
The Reveal LINQ™ device with the investigational RAMware download may present data that 
are different than anticipated due to unknown circumstances or medical conditions. 
• 
There may be other discomforts and risks related to the Reveal LINQ™ device with 
investigational RAMware download and/or this study that are not foreseen at this time. 
 
 
11.2 Risk Minimization 
As referenced above, the potential risks associated with the LINQ™ HF and ALLEVIATE-HF investigational 
RAMware were identified, assessed, evaluated and effectively controlled. Any potential risks associated 
with this study are further minimized by selecting qualified investigators and training study personnel on 
the Clinical Investigation Plan. 
In addition, investigators will be actively involved in the implantation and regular follow-up of the 
subjects implanted with the Reveal LINQ™ with investigational RAMware systems. At each office follow- 
up visit required per protocol (Table 3: Data collection and study procedure requirements at subject 
visits), the Reveal LINQ™ device will be interrogated, device data collected to verify appropriate device 
function and patient’s health assessed for any adverse events. 
Medtronic is further minimizing the possibility of risks by performing required laboratory and pre-clinical 
testing prior to the clinical study, implementing quality control measures into production processes, 
providing guidelines for subject selection and evaluation, and providing adequate instructions and 
labeling. 
Table 8: Potential Risks and Risk Minimization 
Potential Risk 
Minimization 
ICM Pocket Infection from implant/ 
explant procedure or over duration 
of implant 
• 
Adherence to international standards for sterility of 
implanted products 
• 
The product packaging designed to protect device 
sterility 
• 
The insertion procedure and tools are designed to be 
minimally invasive 
• 
Wound check following implant, per site’s practice 

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Potential Risk 
Minimization 
Allergic reaction or ICM Rejection 
following implant procedure 
• 
Assessment of subjects to ensure no Allergic or rejection 
reaction to materials used in incision/insertion tools, 
Reveal LINQ™ ICM exterior or incision closure method 
• 
Wound check following implant, per site’s practice 
• 
Close monitoring with follow-up appointments 
• 
Investigator discretion to remove ICM and report study 
deviation 
• 
Use of biocompatible materials in the Incision/ Insertion 
Tools and Reveal LINQ™ ICM exterior patient-contacting 
surfaces 
Excessive ICM Migration following 
implant procedure (internal device 
movement and externalization) 
• 
Training and Information for User on the Reveal LINQ™ 
implant technique and incision closure techniques 
• 
Use of the implant tools to create small incision and tight 
pocket 
• 
Wound check following implant, per site’s practice 
• 
Investigator discretion to remove if deemed medically 
necessary 
• 
IFUs (Instructions for Use) provide information regarding 
medical procedures and activities which may interact 
with the ICM. 
• 
Reveal LINQ™ ICM design includes anti-migration 
features on the header 
Blunt Tissue Injury/Tissue or Vascular 
Trauma, bleeding from implant/ explant 
procedure 
• 
The ICM and implant procedure are designed to be 
minimally invasive. 
• 
Insertion Tool has a stop position that prevents insertion 
of the probe beyond the distance required for implant. 
• 
Training on the correct use of implant tools 
• 
Selection of experienced investigators 
Pain, Scarring from implant/explant 
procedure or implanted device 
• 
The shape and small device size minimize the invasiveness of 
the implant and explant procedures, and the discomfort 
patients may experience from having an ICM. 
• 
Use of incision tool will produce the smallest incision 
possible for implant 
Toxicity risks due to ICM battery 
• 
Battery and device and hermeticity and reliability 
requirements prevent leakage of toxic substances. 

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Potential Risk 
Minimization 
Premature/Unexpected ICM explant 
/revision 
• 
The projected longevity of a Reveal LINQ™ device with 
investigational RAMware shows a 5 month decrease in 
average projected service life compared to a LINQ™ 
device without the RAMware. The exact service life of 
the LINQ™ device will vary depending on each subject’s 
use. 
Electromagnetic interference 
• 
Design consideration and precautions in place for the 
Reveal LINQ™ system remain effective to address EMI 
risks 
• 
Information regarding EMI (possible sources and ways to 
reduce interference) is provided to the user 
• 
The system adheres to international standards for the 
production of RF energy, reducing the probability of 
interference with other equipment. 
Pain or stimulation due to electrical 
currents or ICM heating 
• 
Design controls in place to protect against leakage currents in 
normal and fault conditions 
• 
Design controls are in place to protect against device heating in 
normal and fault conditions. 
• 
The amount of current injected as part of the impedance 
measurements has been minimized to prevent subject harm 
Missing/Misleading information causing 
inappropriate medical intervention 
• 
The system uses data integrity checks to detect data corruption 
and notify the clinician 
• 
The system ensures components are compatible with the 
system components; the instructions for use provide guidance 
on maintenance of the system (e.g., software/app updates) 
• 
The system provides notifications to the clinician regarding 
system status (e.g., patient transmissions, battery status) 
Injury due to mechanical device failure 
• 
Mechanical device integrity requirements were implemented 
and verified. They have been validated against the expected use 
conditions. 
Security vulnerability impacting device 
settings, data integrity, 
communications, or longevity 
• 
The system uses encrypted communication to transfer data 
• 
The system detects unauthorized messages and takes actions to 
protect itself. 
Denial of access to medical therapy or 
diagnostic 
• 
The ICM is MRI conditional 
• 
The system provides information about the compatibility of the 
ICM with common medical procedures 
• 
The system provides means to non-invasively identify the ICM, 
so its compatibility can be verified prior to the procedure. 
Failure to seek necessary medical 
attention 
• 
Instructions for use warns users against use of the ICM system 
as a real-time / emergency monitoring system. 

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Potential Risk 
Minimization 
Removal and disposal of system 
components (biohazards, 
environmental/property damage 
hazards) 
• 
The insertion tools are designed to be easily disposed of 
• 
The IFU provides guidance on disposal of the ICM at the end of 
service 
Undesired device interactions with the 
investigational RAMware 
• 
Device interactions analysis to ensure there are no 
undesired interactions between the investigational 
RAMware and the Reveal LINQ™ device firmware. 
• 
The investigational RAMware is designed to be automatically 
removed by the ROM code during POR processing 
 
There may be a concern for electrical or electromagnetic interference between the LINQ™ device and 
the other associated study equipment. Among the systems that have the potential for electromagnetic 
interference, here are the associated frequencies and characteristics: 
• 
LINQ™ – transmits and receives Telemetry B signal frequencies for communication with 
programmer 
• 
DR220 Holter – receives Telemetry B signal frequencies for recording 
• 
MyCareLink Home Monitor – receives Telemetry B signal frequencies from LINQ and transmits data 
to the CareLink Network using 3G cellular frequencies 
• 
Emfit bed monitor – the sensor component uses passive electrical signals to collect motion from 
the ribbon. No electrical signal is transmitted to take a measurement. The data is then 
transmitted from the communication hub using 3G cellular frequencies 
It appears that there should not be any electromagnetic interference from transmission by any of the 
planned study equipment. However, should it occur, electromagnetic interference can be mitigated by 
user intervention, such as positioning devices to minimize interference. 
There may be additional discomforts and risks associated with the Reveal LINQTM device or participation 
in this study that are not foreseen at this time. 
 
 
11.3 Potential Benefits 
The Reveal LINQ™ for COPD study may offer no direct personal benefit to individual subjects. 
Subjects may benefit from continuous arrhythmia monitoring with the Reveal ICM, as this monitoring 
could result in diagnosis of Atrial Fibrillation (or other arrhythmias) and comprehensive evaluation of 
symptoms on an earlier and more conclusive basis than what would be possible without an implantable 
cardiac monitor. Subjects may also benefit from being evaluated more frequently in the office according 
to the study visit schedule. 

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The information gained from this study could result in the improved management of other patients 
receiving a Reveal LINQ™ device in the future. Additionally, information collected from this study may 
assist in the design of new product(s)/therapy(ies) and/or instructions for use. 
11.4 Risk-Benefit Rationale 
Since the differences between the Reveal LINQ™ market-released device and the Reveal LINQ™ device 
with the investigational RAMware download are minimal, both devices are used in accordance with the 
Reveal LINQ™ implant manual and/or user manual, as applicable. The risks associated with the device 
are similar as would be the case if the subject received a Reveal LINQ™ device outside the study context. 
The risks introduced by the investigational RAMware are being evaluated and risk control measures 
being implemented to reduce the risk to as low as possible to minimize patient harm. 
The study requirements for careful physician selection and training, and in-office visits carry potential 
benefits that might not be present if the subject was not enrolled in the study. Hence, for individual 
subjects, participation in the study may have greater benefit than risk. Moreover, the value of the 
knowledge to be gained by conducting this clinical study could help in the diagnosis of future patients. 
Lastly, the prospective benefit to subjects of having Reveal LINQ™ cardiac monitoring, with the potential 
to diagnose life-threatening arrhythmias, may provide the patient significant clinical benefit. 
 
12. 
Adverse Events and Device Deficiencies 
 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are 
crucial for the protection of subjects. Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide. Medtronic has established procedures in conformity with worldwide regulatory 
requirements to ensure appropriate reporting of safety information. This study will be conducted in 
accordance with these procedures and regulations. 
12.1 Adverse Events 
To ensure that all AEs that are potentially relevant are collected, the following subset of AEs will be 
collected throughout a subject’s participation, starting at the time the informed consent form is signed: 
• 
All Reveal LINQTM Procedure related AEs 
• 
All Reveal LINQTM System related AEs 
• 
All Serious AEs 
• 
All Pulmonary related AEs 
• 
All Cardiovascular related AEs 
 
Reporting of AEs to Medtronic will occur on an Adverse Event e-CRF, including a description of the 
event, the diagnosis, the date of event onset, the date the site became aware of the event, the 
relatedness and seriousness of the event, diagnostic tests and procedures performed, actions taken as a 

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result of the event, and outcome of the event. Each AE must be recorded on a separate AE eCRF. Subject 
deaths are also required to be reported and should be collected on an AE CRF with a Fatal outcome. 
Refer to section 12.6 for subject death collection and reporting requirements. 
Documented pre-existing conditions are not considered AEs unless the nature or severity of the 
condition has worsened post implant. In all geographies, unavoidable adverse events, listed in Table 9, 
need not be reported unless the adverse event worsens or is present outside the stated timeframe. 
12.2 Device Deficiency 
Device deficiency (DD) information will be collected throughout the study and reported to Medtronic. 
Reporting of DDs to Medtronic will occur on a device deficiency e-CRF. Note that DDs that result in an 
adverse device effect (ADE) to the subject should be captured on an AE CRF only. Device deficiencies 
that did not lead to an AE but could have led to a serious adverse device effect (SADE) (i.e., if suitable 
action had not been taken, if intervention had not been made, or if the circumstances had been less 
fortunate) require immediate reporting. 
12.3 Processing Updates and Resolution 
For any changes in status of a previously reported AE (i.e. change in actions taken, change in outcome, 
change in relatedness), an update to the original AE must be provided. All reported adverse events must 
be followed until the adverse event has been resolved, the subject exits the study or until study closure, 
whichever occurs first. At the time of study exit, all collected AEs with an outcome of “not 
recovered/not resolved”, “recovering/resolving” or “unknown” must be reviewed and updates provided 
as applicable. 
12.4 Definitions/Classifications 
Adverse event (AE) and device deficiency (DD) ISO 14155:2020 definitions are provided in Table below. 
Where the definition indicates “device”, it refers to any device used in the study. This might be the 
device under investigation, or any market released component of the system. 
Table 9: Adverse Event and Device Deficiency Definitions 
 
General 
Adverse Event (AE) 
(ISO 14155:2020 section 3.2) 
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 investigational medical device and 
whether anticipated or unanticipated. 
NOTE: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE: This definition includes events related to the 
procedures involved. NOTE: for users or other 

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persons, this definition is restricted to events 
related to investigational medical devices. 
(ISO 14155:2020 section 3.2) 
Adverse Device Effect (ADE) 
(ISO 14155:2020 section 3.1) 
Adverse event related to the use of an 
investigational medical device. NOTE: This 
definition includes adverse events resulting from 
insufficient or inadequate instructions for use, 
deployment, implantation, installation, or 
operation or any malfunction of the 
investigational medical device. 
NOTE: This definition includes any event resulting 
from use error or from intentional misuse of the 
investigational medical device. 
NOTE: This includes ‘comparator’ if the comparator is a 
medical device. 
Device Deficiency (DD) 
(ISO 14155:2020 section 3.19) 
Inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or 
performance. 
Note: Device deficiencies include malfunctions, 
use errors, and inadequate labelling. 
Relatedness 
Procedure Related 
An adverse event that occurs that is directly related to 
the insertion or modification of the Reveal LINQ™ 
system. 
System Related 
An adverse event that results from the presence or 
performance of any component of the Reveal LINQ™ 
system (including the LINQ™ device, incision/insertion 
tools, patient assistant and programmer). 
Pulmonary Related 
An adverse event associated with the lungs in which 
signs and symptoms are experienced in either the 
upper or lower Respiratory systems (i.e. COPD, 
Pneumonia, Asthma, Bronchitis, etc.). 
COPD Event 
An adverse event where the underlying COPD condition 
exacerbates beyond normal day-to-day variations, 
where an increase in dyspnea, cough, and/or sputum 
production presents with acute onset and necessitates 
supplementing regular COPD medications with 
antibiotics for respiratory pathogens and/or steroids 
Cardiovascular Related 
An adverse event related to the heart and blood vessels or 
the circulation. 
Heart Failure Event 
A heart failure event is defined as any cardiovascular- 
related (including hypervolemia) Health Care 
Utilizations (HCUs) for any one of the following events. 

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• 
Admission with primary diagnosis of HF 
• 
Intravenous HF therapy (e.g. IV 
diuretics/vasodilators) or ultrafiltration at any 
one of the following settings: Admission with 
secondary/tertiary diagnosis of HF, 
Emergency Department, Ambulance, 
Observation Unit, Urgent Care or 
HF/Cardiology Clinic 
Note: Only the Sponsor will be classifying Heart Failure 
Event relatedness. 
Not Related 
Relationship to the device or procedures can be 
excluded when: 
• 
The event is not a known side effect of 
the product category the device belongs 
to or of similar devices and procedures; 
• 
The event has no temporal relationship 
with the use of the device or the 
procedures; 
• 
The serious event does not follow a 
known response pattern to the medical 
device (if the response pattern is 
previously known) and is biologically 
implausible; 
• 
The discontinuation of medical device 
application or the reduction of the level 
of activation/exposure – when clinically 
feasible – and reintroduction of its use 
(or increase of the level of 
activation/exposure) do not impact the 
serious event; 
• 
The event involves a body-site, or an 
organ not expected to be affected by the 
device or procedure; 
• 
The serious event can be attributed to 
another cause (e.g., an underlying or 
concurrent illness/clinical condition, an 
effect of another device, drug, treatment, 
or other risk factors); 
• 
The event does not depend on a false 
result given by the device used for 
diagnosis (when applicable); 
• 
Harm to the subject are not clearly due 
to use error; 

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In order to establish the non-relatedness, not all the 
criteria listed above might be met at the same time, 
depending on the type of device/procedures and the 
event. 
Unlikely 
The relationship with the use of the device seems not 
relevant and/or the event can be reasonably explained 
by another cause, but additional information may be 
obtained. 
Possible 
The relationship with the use of the investigational 
device is weak but cannot be ruled out completely. 
Alternative causes are also possible (e.g. an underlying 
or concurrent illness/ clinical condition or/and an effect 
of another device, drug or treatment). Cases were 
relatedness cannot be assessed or no information has 
been obtained should also be classified as possible. 
Probable 
The relationship with the use of the investigational 
device seems relevant and/or the event cannot 
reasonably be explained by another cause, but 
additional information may be obtained. 
Causal Relationship 
The event is associated with the device or study 
procedures beyond reasonable doubt when: 
• 
The event is a known side effect of the 
product category the device belongs to or of 
similar devices and procedures; 
• 
The event has a temporal relationship with 
device use/application or procedures; 
• 
The event involves a body-site or organ that 
the device or procedures are applied to or 
the device or procedures have an effect on; 
• 
The serious event follows a known response 
pattern to the medical device (if the response 
pattern is previously known); 
• 
The discontinuation of medical device 
application (or reduction of the level of 
activation/exposure) and reintroduction of its 
use (or increase of the level of 
activation/exposure) impact on the serious 
event (when clinically feasible); 
• 
Other possible causes (e.g., an underlying or 
concurrent illness/clinical condition or/and 
an effect of another device, drug, or 
treatment) have been adequately ruled out; 
• 
Harm to the subject is due to error in use; 

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• 
The event depends on a false result given by 
the device used for diagnosis (when 
applicable); 
In order to establish the relatedness, not all the criteria 
listed above might be met at the same time, depending 
on the type of device/procedures and the serious 
event. 
Seriousness 
Serious Adverse Event (SAE) 
(ISO 14155:2020 section 3.45) 
An AE that: 
• 
Led to death 
• 
Led to a serious deterioration in the health of the 
subject, resultingin: 
o 
A life-threatening illness or injury, or 
o 
A permanent impairment of a body 
structure or a body function, or 
o 
In-patient or prolonged hospitalization, or 
o 
Medical or surgical intervention to 
prevent life-threateningillness or injury 
or permanent impairment to a body 
structure or a body function, 
• 
Led to fetal distress, fetal death or a 
congenital abnormality orbirth defect. 
Note: Planned hospitalization for a pre-existing 
condition, or a procedure required by the CIP, 
without serious deterioration in health, is not 
considered a SAE. 
Serious Adverse Device Effect (SADE) 
(ISO 14155:2020 section 3.44) 
Adverse device effect that has resulted in any of 
the consequences characteristic of a serious 
adverse event. 
. 
Complication 
An adverse event that includes the following is 
considered a complication: 
• 
Results in death, 
• 
Involves any termination of significant 
device function, or 
• 
Requires an invasive intervention 
Non-invasive (21 CFR 812): when applied to a 
diagnostic device or procedure, means one that does 
not by design or intention: 
• 
Penetrate or pierce the skin or mucous 
membranes of the body, the ocular cavity, 
or the urethra, or 

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o 
Penetrate: to pass, extend, 
pierce, or diffuse into or through 
something; to enter by 
overcoming resistance; to gain 
entrance to 
o 
Pierce: to force a way into or through 
something 
• 
Enter the ear beyond the external auditory 
canal, the nose beyond the nares, the 
mouth beyond the pharynx, the anal canal 
beyond the rectum, or the vagina beyond 
the cervical os 
Note (FDA): Blood sampling that involves simple 
venipuncture is considered noninvasive, and the use of 
surplus samples of body fluids or tissues that are left 
over from samples taken for non- investigational 
purposes is also considered noninvasive. 
Observation 
Any Adverse Event that is not a complication. 
Note 1: Pulmonary related AEs will be the only AEs 
requiring classification of either Complication or 
Observation by Sponsor and EAC. 
Unanticipated Adverse Device Effect (UADE) 
(21 CFR 812.3(s)) 
Any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or 
death, was not previously identified in a nature, 
severity, or degree of incidence in the investigational 
plan or application (including a supplementary plan or 
application), or any other unanticipated serious 
problem associated with a device that relates to the 
rights, safety, or welfare of subjects. 
Other 
Unavoidable Adverse Event 
An Adverse Event inherent to a surgical procedure that 
is expected to occur in all subjects for a projected 
duration according to the Investigator’s opinion, 
including, but not limited to: 
Event Description 
Timeframe 
(hours) from 
the Surgical 
Procedure 
Pocket site / Incisional pain 
72 
Mild to moderate bruising / 
ecchymosis 
168 

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12.5 Reporting of Adverse Events 
To ensure that all AEs that are potentially relevant are collected, the following subset of AEs will be 
collected throughout a subject’s participation, starting at the time the informed consent form is signed: 
• 
All Reveal LINQTM Procedure related AEs 
• 
All Reveal LINQTM System related AEs 
• 
All Serious AEs 
• 
All Pulmonary related AEs 
• 
All Cardiovascular related AEs 
 
Reporting of AEs to Medtronic will occur on an Adverse Event e-CRF, including a description of the 
event, the diagnosis, the date of event onset, the date the site became aware of the event, the 
relatedness and seriousness of the event, diagnostic tests and procedures performed, actions taken as a 
result of the event, and outcome of the event. Each AE must be recorded on a separate AE eCRF. Subject 
deaths are also required to be reported and should be collected on an AE CRF with a Fatal outcome. 
Refer to section 12.6 for subject death collection and reporting requirements. 
Documented pre-existing conditions are not considered AEs unless the nature or severity of the 
condition has worsened post implant. In all geographies, unavoidable adverse events, listed in Table 10, 
need not be reported unless the adverse event worsens or is present outside the stated timeframe. 
12.5.1 
Adverse Event and Device Deficiency Classification 
All reported AEs and DDs will be reviewed by a Medtronic representative. Adverse events will be 
classified according to the standard definitions as outlined in Table 9. 
Upon receipt of AEs and DDs at Medtronic, a Medtronic representative will review the AE/DD for 
completeness and accuracy and when necessary will request clarification and/or additional information 
from the investigator. Medtronic will utilize the Medical Dictionary for Regulatory Activities (MedDRA), 
to assign a MedDRA term for each AE based on the information provided by the investigator. 
Regulatory reporting of AEs and DDs that could have led to a SADE will be completed according to local 
regulatory requirements. Refer to Table 11 for a list of required investigator and Medtronic reporting 
requirements and timeframes. It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the IRB/EC responsible for oversight of the study at their site. 
For emergency contact regarding a SAE and/or SADE, contact a Medtronic study representative 
immediately (refer to the study contact list provided in the site’s study documents binder/investigator 
site file or refer to the Sponsor Contact Information section provided in the CIP). 
An Event Adjudication Committee (EAC) will review the Pulmonary related AEs and will provide a COPD 
event relatedness adjudication and a Complication or Observation classification for each Pulmonary 

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related event. The EAC will additionally be providing a death classification for all reported AEs with an 
outcome of fatal. 
Table 10: Adverse Event Classification Responsibilities 
 
What is classified? 
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Reveal LINQ™ system related, Reveal LINQTM procedure 
related, Pulmonary Related, Cardiovascular related 
Sponsor 
Reveal LINQ™ system related, Reveal LINQTM procedure 
related, Pulmonary Related, Cardiovascular related, Heart 
Failure Event, COPD event 
Seriousness 
Investigator 
SAE, Device Deficiency with SADE potential 
Sponsor 
SAE, Device Deficiency with SADE potential, UADE, 
Complication/Observation 
AE Term (Diagnosis) 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the term provided by 
Investigator 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, 
Unknown 
 
 
12.5.2 
Adverse Event and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and DDs will be completed according to local regulatory requirements. 
Investigator and sponsor reporting requirements are outlined in Table 11. It is the responsibility of the 
investigator to abide by the adverse event and device deficiency reporting requirements stipulated by 
local law and the site’s IRB/EC. 
For adverse events and device deficiencies that require immediate reporting, initial reporting may be 
completed by contacting the study sponsor (refer to the study contact list provided in the site’s study 
documents binder/investigator site file or refer to the contact information provided in Table 1). 
Table 11: Reporting Requirements 
 
Serious Adverse Device Effects (SADEs) 
Investigator submit to: 
Medtronic 
Submit as soon as possible as per local reporting requirement, but not later 
than within 10 working days after the investigator first learns of the event. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
Regulatory Authorities 
Submit per local reporting requirement. 

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Sponsor submit to: 
Regulatory Authorities 
Submit as soon as possible as per local reporting requirement, but not later 
than within 10 working days after the investigator first learns of the event. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
Serious Adverse Events (SAE)/ Adverse Device Effects (ADE) 
Investigator submit to: 
Medtronic 
Submit as soon as possible as per local reporting requirement, but not later 
than within 10 working days after the investigator first learns of the event. 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
Sponsor submit to: 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
All other AEs 
Investigator submit to: 
Medtronic 
Submit as soon as possible as per local reporting requirement after the 
investigator first learns of the event. 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
Sponsor submit to: 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
Device Deficiency with SADE potential 
Investigator submit to: 
Medtronic 
Submit as soon as possible as per local reporting requirement, but not later 
than within 48 hours after the investigator first learns of the event. 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
Sponsor submit to: 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
Submit as soon as possible as per local reporting requirement, but not later 
than within 48 hours after the investigator first learns of the event. 
Regulatory Authorities 
Submit per local reporting requirement. 
IRB/Ethics Committee 
Submit per local reporting requirement. 

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12.6 Subject Death 
All subject deaths must be reported by the investigator to Medtronic on an AE form (AE with fatal 
outcome) as soon as possible after the investigator first learns of the death. In case of death, there 
should be one AE CRF with an outcome of fatal. 
In the event of a subject’s death, the inserted system should be explanted and returned to Medtronic 
for analysis whenever possible. Local laws and procedures must be followed where applicable. If any 
device or system component is returned to Medtronic, internal returned product reporting systems may 
be used to gather additional information about the returned device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic clinical study team. When a death occurs in a hospital, a copy of the death summary report 
and all relevant hospital records should be sent to the Medtronic clinical study team, if available. If an 
autopsy is conducted, the autopsy report should also be sent to the Medtronic clinical study team if 
available and allowed by state/local law. When the death occurs at a remote site, it is the investigative 
site’s responsibility to attempt retrieval of information about the death. Additionally, device disposition 
information should be updated. In summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death 
• 
Relatedness to system and/or procedure 
• 
Device interrogation (if available, postmortem preferred) 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and/or allowed by state/local law) 
12.6.1 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. 
The Investigator shall classify each subject death per the following definitions: 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the heart. 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart disease may have 
been known to be present, but the time and mode of death are unexpected. If time of onset cannot be 
determined, SCD will alternatively be defined as any unexpected cardiac death occurring out of the 
hospital or in the emergency room as dead on arrival. 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, including all 
cardiac deaths of hospitalized subjects on inotropic support. 
Non-cardiac Death: A death not classified as a cardiac death. 

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Unknown Cardiac Classification: Unknown death classification is intended for use only when there is 
insufficient or inadequate information to classify the death. 
The EAC will review all AEs with a fatal outcome and provide a final adjudication of both COPD event and 
death classification. Regulatory reporting of subject deaths will be completed according to local 
regulatory requirements. Refer to Table 11 for investigator and sponsor reporting requirements and 
timeframes. 
12.7 Product Complaint Reporting 
In geographies where devices are market-released, product complaint reporting is applicable. This 
includes when an AE is related to a market-released device during the study. The reporting of product 
complaints is not part of the clinical study and should be done in addition to the Adverse Event reporting 
requirements. Refer to local regulations for reporting requirements. 
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that 
has been placed on the market. 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse 
of the product. Reporting must be done immediately and via the regular channels for market-released 
products. 
Medtronic will notify the regulatory authorities, as applicable for the following incidents immediately 
upon learning of them: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well 
as any inadequacy in the labeling or instructions for use which led or might have led to the 
death or serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
 
13. 
Data Review Committees 
 
13.1 Event Adjudication Committee 
At regular intervals, an Event Adjudication Committee (EAC) will review and adjudicate at a minimum, all 
events classified by the investigator or Medtronic as Pulmonary related and all AEs with a fatal outcome. 
The EAC will provide an adjudication for COPD event and a Complication or Observation classification for 
all AEs that are reviewed. The EAC will additionally provide a death classification for all AEs with an 
outcome of fatal. The EAC will consist of a non-Medtronic employed physicians that are not participating 
investigators for the study. 
Medtronic personnel may facilitate and participate in an EAC meeting but will be non-voting members. 

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For all adverse events reviewed by the EAC, Medtronic will provide the EAC with the investigator’s 
description and classification. The EAC is responsible for reviewing the investigator’s assessment and 
supportive documentation (when available), reviewing applicable definitions, and determining final 
classifications for all adjudication parameters. 
13.2 CRO 
CRO and core lab information is provided below. This information is subject to change during the clinical 
study. Periodic updates to CRO and core labs information will be sent to the centers as needed. 
Table 12: CRO Information 
 
Contact Information 
Duties performed 
Cognizant Technology Solutions 
XXXXXXXXXXXXXXXXX  
XXXXXXXXXXXXXXX 
XXXXXXXXXX 
XXXXXXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXXX 
• 
Development of study electronic case report forms, edit 
checks, and study management reports. 
• 
Review of electronic case report forms, management of 
discrepancies, and coding of deviations. 
 
14. 
Statistical Design and Methods 
 
The LINQTM for COPD is a prospective, non-randomized, multi-center, observational, pre-market clinical 
study. The purpose of the study is to characterize the Reveal LINQ™ derived data from patients with 
COPD. 
This is a feasibility study that is exploratory in nature and with no hypothesis. Therefore, justification on 
sample size is not required. The study plans to enroll up to 100 subjects from up to 10 centers in the 
United States, with no more than 20 subjects enrolled per site. Enrolled subjects are expected to be 
followed up for at least 12 months after the insertion of Reveal LINQ™ device and download of either 
the LINQ HF or ALLEVIATE-HF investigational RAMware. The expected total study duration is 
approximately 33 months, representing approximately 26 months of patient enrollment and 6 months 
of subject follow-up with up to 1 month between enrollment and insertion. 
14.1 General Aspects of Analysis 
Medtronic statisticians or designees will perform all statistical analyses. 
The study is exploratory in nature with no formal statistical hypothesis planned. A separate Statistical 
Analysis Plan (SAP) will be developed and include a comprehensive description of the statistical methods 
and analyses to be included in the final study report. Any change to the data analysis methods described 
in the protocol will require an amendment only if it changes a principal feature of the protocol. Any 
other change to the data analysis methods described in the protocol, and the justification for making the 
change, will be described in the clinical study report. 

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14.2 Analysis Execution 
The study objective will be analyzed after the last subject exits the study. 
14.3 Primary Objective 
The primary objective is to characterize Reveal LINQ™ derived data from patients with COPD by 
assessing the relationship between changes in LINQ™ derived data with subsequent COPD events. 
14.3.1 
Hypothesis 
There is no statistical hypothesis for this objective. 
14.3.2 
Endpoint Definition 
The COPD events as adjudicated by the EAC will be used in the analysis. In the case where a subject has 
multiple COPD events per EAC adjudication during the study, all the COPD events of the subject will be 
included in the analysis. 
 
According to section 5.1, COPD event is defined as an adverse event where the underlying COPD 
condition exacerbates beyond normal day-to-day variations, where an increase in dyspnea, cough, 
and/or sputum production presents with acute onset and necessitates supplementing regular COPD 
medications with antibiotics for respiratory pathogens and/or steroids. 
14.3.3 
Analysis Methods 
Data from multiple study components will be collected in this study, of which the Reveal LINQ™ HF 
derived data is of the most interest. This includes subcutaneous electrocardiogram, impedance, 
temperature, accelerometer and patient activity measurements. 
Descriptive statistics such as mean and standard deviation for continuous variables and count and 
proportion for categorical variables will be used to summarize the derived data from Reveal LINQ™ HF. 
The relationship between changes in LINQ™ derived data and COPD events per EAC adjudication will be 
evaluated. Specifically, for each subject that has experienced at least one COPD event per EAC 
adjudication, the average daily measurements of LINQ™ derived data before and after a COPD event will 
be plotted to identify patterns and signals related to the occurrence of the COPD event. 
Baseline data such as demographics, medical history, physical exam (heart rate, blood pressure, weight, 
spirometry assessment, etc.), and blood measurements (Creatinine, BNP, NT-pro BNP, White Blood Cells 
and Eosinophils) will also be summarized using descriptive statistics. 
14.3.4 
Determination of Subjects/Data for Analysis 
Enrolled subjects who have Reveal LINQTM device successfully inserted and have either the LINQ™ HF or 
ALLEVIATE-HF investigational RAMware successfully downloaded to the device and who have completed 
a first successful CareLink transmission. 

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14.4 Sample Size Determination 
There are no sample size requirements as this is an observational study with no hypothesis for the study 
objective. A sample size of up to 100 enrolled subjects was selected assuming sufficient data can be 
collected from this cohort to explore the relationship between changes in LINQ™ derived data with 
COPD events. 
According to a review by Seemungal et al., the annual rates of COPD exacerbations were estimated to be 
as low as 0.5 to a high of 3.5 exacerbations per patient from several studies, and hospitalization rates 
ranged from as low as 0.09 to 2.4 per patient per year.13 This study requires that a subject should have 2 
COPD exacerbations within the previous 12 months as one of the inclusion criteria. Assuming the COPD 
exacerbation rate remains as 2 COPD exacerbations per patient year after subjects are enrolled, a group 
of 60 enrolled subjects being followed up for 12 months after successful insertion of Reveal LINQTM 
device and download of the investigational RAMware would expect to have 120 COPD exacerbations. 
Assuming 50% of the COPD exacerbations would meet the study definition of “COPD event”, a total of 
60 COPD events would be expected. 
14.5 Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Subjects will undergo screening to confirm eligibility with defined inclusion/exclusion criteria prior 
to enrollment. 
• 
All sites will use the same version of the Clinical Investigation Plan and electronic case report forms 
(eCRFs). 
• 
All investigational site personnel and Medtronic personnel will be trained using standardized 
training materials. 
• 
Monitoring visits will be conducted for adherence to the CIP and verification of source data. 
• 
An independent Event Adjudication Committee (EAC) will be used to review and adjudicate at a 
minimum, all Pulmonary related AEs and all AEs with a fatal outcome. 
• 
A statistical analysis plan will be developed prior to analyzing data. The plan will document all pre- 
specified analyses and analysis methods. 
In summary, potential sources of bias that may be encountered in this clinical study have been 
considered and minimized by careful study design. 
14.6 Missing data 
Missing data will not be imputed. An adjudicated COPD event will be considered in the analysis to assess 
changes in LINQ™ derived data if it has Reveal LINQ™ data before and after the event onset date. 

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14.7 Additional Considerations Due to COVID-19 
• 
Subject follow-up visits. 
Follow-up visits every three months post device insertion will be done by telephone or in-person 
if desired. The flexibility in the way to complete these visits will allow subjects to continue to be 
followed in the study as well as to follow local COVID-19 guidelines. 
• 
COPD exacerbation rate. 
A patient with COVID-19 may be at higher risk of a COPD exacerbation event. At the same time 
there could be underreporting of COPD exacerbation events compared to literature. Therefore, 
the impact of COVID-19 on the COPD exacerbation rate is unknown. 
• 
COPD event outcome. 
Under potentially limited care resources of sites due to COVID-19, subjects with COPD may 
experience delayed treatment that could also increase the subject’s risk of worse outcomes. In 
addition, subjects with COPD may experience worse/poorer event outcomes if also infected by 
COVID-19. 
 
15. 
Ethics 
 
15.1 Statement(s) of Compliance 
The LINQTM for COPD Study will be conducted according to the Declaration of Helsinki, Version 2013, 
Clinical Investigation Plan, Good Clinical Practice (GCP) and in accordance to the national and local laws, 
regulations, standards, and requirements of the countries/geographies in which the study is conducted. 
The principles of the Declaration of Helsinki are implemented in this study by means of the informed 
consent process, Ethics Board approval, study training, clinical trial registration, and risk benefit 
assessment. The sponsor shall avoid improper influence on, or inducement to, the subject, monitor, any 
investigator(s) or other parties participating in, or contributing to, the LINQTM for COPD Study. 
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP). GCP includes review and approval by an independent Ethics Board 
before initiating a study, continuing review of an ongoing study by an Ethics Board and obtaining and 
documenting the freely given informed consent of a subject before initiating the study. 
Ultimately, all sites in all geographies will follow and comply with: 
• 
Principles of Declaration of Helsinki 
• 
21 CFR Part 11: Electronic Records, Electronic Signatures 
• 
21 CFR Part 54: Financial Disclosure by Clinical Investigators 
• 
The Clinical Trial Agreement 
• 
The procedures described within this CIP 
• 
Local Ethics Board Requirements 

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In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to the following: 
In the US, the study will be conducted in compliance with: 
• 
21 CFR Part 50: Protection of Human Subjects 
• 
21 CFR Part 56: Institutional Review Boards 
• 
21 CFR Part 803: Medical Device Reporting 
• 
21 CFR Part 54: Financial Disclosure 
• 
21 CFR Part 812 Investigational Device Exemptions 
 
The study will not begin until IRB/EC and regulatory authority approvals/notification, as appropriate, are 
received. 
The study will be publicly registered on http://clinicaltrials.gov prior to first enrollment in accordance 
with the 2007 Food and Drug Administration Amendments Act (FDAAA) and Declaration of Helsinki on 
(PL 110-85, Section 810(a)). 
 
16. 
Study Administration 
 
16.1 Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of the LINQTM for COPD clinical study. 
Trained Medtronic personnel or delegates appointed by Medtronic may perform study monitoring at 
the study site in order to ensure that the study is conducted in accordance with the CIP, the clinical trial 
agreement and applicable regulatory and local requirements. Medtronic, or delegates, must therefore 
be allowed access to the subjects’ case histories (clinic and hospital records, and other source 
data/documentation) upon request as per the informed consent form, Data Protection Authorization 
(where applicable) and clinical trial agreement. The principal investigator should also be available 
during monitoring visits. 
16.1.1 
Monitoring Visits 
Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, will 
be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, and regulatory compliance, including but not limited to IRB/EC approval and 
review of the study, maintenance of records and reports, and review of source documents against 
subject eCRFs. Monitors review site regulatory and study compliance by identifying findings of non- 

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compliance and communicating those findings to site personnel. Monitors may work with study 
personnel to determine recommendations for preventative/corrective/effectiveness action(s) 
recommendations and to identify trends within the study or at a particular site. 
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring visits 
and any suspected inconsistency in data that requires investigation. Regulatory documents may be 
reviewed at each study center. 
16.2 Data Management 
Electronic case report form (e-CRF) data will be stored in a secure, password-protected database which 
will be backed up nightly. Data will be reviewed using programmed and manual data checks. Data 
queries will be made available to sites for resolution. Study management reports may be generated to 
monitor data quality and study progress. 
Device data from CareLink transmissions will be uploaded to secure servers. Upon receipt, device data 
will be maintained within databases and retrieved for analysis and reporting. 
Changes to the data elements in the electronic system will retain the original data and an audit trail 
(date, time, and originator of the change and reason). It is possible that AE and device data files may be 
provided to Medtronic before the PI has reviewed and released the e-CRF. At the end of the study, the 
data will be frozen and will be retained indefinitely by Medtronic. 
16.3 Direct Access to Source Data/Documents 
The sponsor or a regulatory authority, including the FDA, may audit or inspect the study site to evaluate 
the conduct of the study. The clinical investigator(s)/institutions(s) shall allow study related monitoring, 
audits, Ethics Board review and regulatory inspection by providing direct access to source 
data/documents. 
16.4 Confidentiality 
All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 
Medtronic in a key coded form, unless it’s impossible to make it anonymous, for instance, where the 
patient’s name cannot be removed from the data carrier, such as fluoroscopy images. 
16.5 Liability 
Warranty information will be provided in the product packing and will be available upon request. 
Insurance information for participating geographies is provided below. 
Medtronic maintains appropriate clinical study 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 study insurance statement/certificate will be provided to the IRB/EC. 

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16.6 CIP Amendments 
Approval of the CIP is required from the following groups prior to any study procedures at a study 
center: 
• 
Medtronic 
• 
An independent Institutional Review Board / Ethics Committee 
Similarly, approval of subsequent revisions to the CIP from the above-mentioned groups is required at 
each study center prior to implementation of the revised CIP at that center. 
16.7 Record Retention 
16.7.1 
Investigator Records 
The investigator is responsible for the preparation and retention of the records including, but not limited 
to those cited below. All of the below records, with the exception of case history records and case 
report forms (CRFs), should be kept in the Investigator Site File (i.e., the study binder provided to the 
investigator) or Subject Study Binder. CRFs must be maintained and signed electronically within the 
electronic data capture system during the study. The following records are subject to inspection and 
must be retained for a period of two years (or longer as local law or hospital administration requires) 
after the date on which the investigation is terminated. Measures shall be taken to avoid loss or 
premature destruction. 
• 
All correspondence between the IRB, sponsor, monitor, regulatory authority and/or the 
investigator that pertains to the investigation, including required reports 
• 
Subject’s case history records, including: 
o Signed and dated informed consent form 
o Observations of adverse events/adverse device effects/device deficiencies 
o Medical history 
o Baseline, LINQ™ Insertion and follow-up data (if applicable) 
o Documentation of the dates and rationale for any deviation from the protocol 
• 
List of investigation sites 
• 
Insurance certificates (if applicable) 
• 
All approved versions of the CIP and Informed Consent Form 
• 
Fully executed Clinical Trial Agreement 
• 
Curriculum Vitae of principal investigator and all co-investigators/sub-investigators 
• 
Documentation of delegated tasks 
• 
Study training records for site personnel involved in the study 
• 
IRB approval documentation, including the IRB composition where required by law, and written 
information that the investigator or other study staff, when member of the IRB, did not 
participate in the approval process 

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• 
Regulatory authority correspondence, notification and approval, where required by national 
legislation 
• 
Any other records that local regulatory agencies require to be maintained 
• 
Final Study Report including the statistical analysis 
16.7.2 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records which include, but are 
not limited to: 
• 
All correspondence which pertains to the investigation 
• 
Executed Clinical Trial Agreement for all participating sites 
• 
Curriculum vitae (signed and dated as required by local law) of principal investigator and all co- 
investigators/sub-investigators at participating sites 
• 
Documentation of delegated tasks for all participating sites 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
All approved informed consent versions, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all IRB approval letters and relevant IRB correspondence and IRB voting 
list/roster/letter of assurance, if applicable 
• 
Electronically signed and dated eCRFs 
• 
List of names, addresses, telephone numbers and professional position of the clinical 
investigators and coordinating clinical investigator(s), if appointed 
• 
Names and addresses of the institutions in which the clinical study will be conducted 
• 
Regulatory authority correspondence, notification and approval as required by national 
legislation 
• 
Names/contact addresses of monitors 
• 
Monitoring reports 
• 
Site qualification visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the clinical study 
• 
The Clinical Investigation Plan and study related reports, and revisions 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
16.8 Reporting Requirements 
16.8.1 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the 
sponsor of all case report forms, adverse events and adverse device effects (reported per the 

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country-specific collection requirements), device deficiencies, deaths, and any deviations from the 
Clinical Investigation Plan. If any action is taken by an IRB/EC with respect to this clinical study, 
copies of all pertinent documentation must be forwarded to Medtronic in a timely manner. Reports 
are subject to inspection and to the retention requirements as described above for investigator 
records. Safety data investigator reporting requirements are listed in section 12.5.2. The 
investigator shall prepare and submit in a complete, accurate and timely manner the reports listed 
in this section. 
Table 13: Investigator Reports 
 
Report 
Submit to 
Description/Constraints 
Withdrawal of IRB 
Approval (either 
suspension or 
termination) 
Sponsor and 
Relevant 
Authorities, if 
applicable 
The investigator must report a withdrawal of approval 
by the reviewing IRB of the investigator’s part of the 
investigation within 5 working days. 
Study Deviations 
Sponsor and 
IRB/EC 
Notice of deviations from the CIP to protect the life or 
physical wellbeing of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working 
days after the emergency occurred. Reporting of all 
other study deviations must comply with IRB/EC 
policies and/or local laws and/or regulatory agency 
requirements and must be reported to Medtronic as 
soon as possible upon the center becoming aware of 
the deviation. 
Progress Report 
Sponsor and 
IRB/EC and 
relevant 
authorities if 
applicable 
The investigator must submit this report to the 
sponsor and IRB at regular intervals, but in no event 
less than yearly. 
Final Report 
Sponsor and 
IRB/EC and 
relevant 
authorities if 
applicable 
This report must be submitted within 3 months of 
study completion or termination of the investigation or 
the investigator’s part of the investigation. 
16.8.2 
Sponsor Reports 
Required sponsor reports are listed in Table 14 below. 

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Table 14: Sponsor Reports 
 
Report 
Submit to 
Description/Constraints 
Premature 
Termination or 
Suspension of the 
Clinical Investigation 
Investigators, 
IRBs/ECs, 
regulatory 
authorities (if 
required per local 
regulations) 
Provide prompt notification of termination or suspension and 
reason(s). 
Progress Reports 
IRB 
Progress reports will be submitted at least annually. (21 CFR 
812.150(b)(5), 812.36(f) 
Recall and device 
disposition 
Investigators, 
IRB 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, or 
otherwise dispose of any devices. (21 CFR 812.150(b)(6)) 
Study Deviations 
Investigators 
Ensure that all deviations from the Clinical Investigation Plan 
are reported on the case report forms and the final report of 
the clinical investigation. 
Site specific study deviations will be submitted to 
investigators annually. 
Final Report 
Investigators, 
IRB/EC, 
regulatory 
authorities (if 
required per local 
regulations) 
Sponsor final report including study analyses will be provided. 
Significant risk device 
determination 
FDA 
If an IRB determines that the device is a significant risk 
device, the sponsor shall submit to FDA a report of the IRB’s 
determination within 5 working days after sponsor learns of 
the determination. (21CFR 812.150(b)(9)) 
Medtronic records and reports will be stored in a password-protected document management system. 
The sponsor and principal investigator shall maintain the clinical investigation documents as required by 
the applicable regulatory requirement(s). They shall take measures to prevent accidental or premature 
destruction of these documents. The principal investigator or sponsor may transfer custody of records 
to another person/party and document the transfer at the investigation site or at the sponsor's facility. 
16.9 Publication and Use of Information 
Publications from the LINQ™ for COPD Study will be handled according to Medtronic’s Policies and 
Standard Operating Procedures and as indicated in the Clinical Trial Agreement. 
16.9.1 
Publication Committee 
The LINQ™ for COPD Study will utilize a Publication Committee which will include the study Oversight 
Committee member as well as Medtronic personnel. This committee will manage study publications 
with the goal of publishing findings from the data. 
The Publication Committee’s role is to: 

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• 
Manage elements addressed in the publication plan as outlined in this section 
• 
Develop the final Publication Plan under a separate cover 
• 
Execute the Publication Plan 
• 
Oversee the publication of primary, secondary and ancillary study results 
• 
Review and prioritize publication proposals 
• 
Provide input on publication content, and 
• 
Apply and reinforce the authorship guidelines set forth in the Publication Plan. 
Membership in the Publication Committee does not guarantee authorship. The committee will meet as 
needed. 
16.9.2 
Management of Primary, and Ancillary Publications 
The Publication Committee reviews, prioritizes, and manages all publications including primary and 
ancillary publications. Primary publications are those that address analyses of the primary objective as 
specified in the Clinical Investigation Plan. An ancillary publication is any publication that does not 
address the primary study objective identified in the Clinical Investigation Plan. They include 
publications proposed and developed by the Publication Committee, other Medtronic departments or 
entities, clinicians participating in this clinical study, and clinicians not participating in this clinical study. 
The committee will work with Medtronic to ensure that requests do not present conflicts with the 
primary results, other proposals, are not duplicative, and to determine which ancillary publication 
proposals, if any, will be supported. 
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual site data. Requests for publications on study objectives utilizing subset data 
(e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide resources. 
16.9.3 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical 
Journal Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org). Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Decisions regarding authorship and contributor ship will be made by the Publication Committee. The 
selected authors will be responsible for drafting the publication. All selected authors must fulfill ICMJE 
authorship conditions to be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic LINQ™ for COPD Study 
Investigators” and will be individually listed according to the guidelines of the applicable scientific 
journal when possible. Any other contributors will be acknowledged by name with their specific 
contribution indicated. 

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16.9.4 
Transparency 
Transparency of study results will be maintained by the following means: 
• 
A final report describing the results of all objectives and analysis will be distributed to all 
investigators and IRBs/ECs and Competent Authorities of participating countries when required 
by local law 
• 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated 
• 
Submitting for publication the primary study results after the study ends 
• 
Disclosing conflicts of interest (e.g., financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences 
• 
Making an individual site’s study data accessible to the corresponding investigator after the 
completion of the study, if requested 
16.10 
Suspension or Early Termination 
16.10.1 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter. Study closure is defined as 
closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been 
satisfied per the CIP and/or by a decision by Medtronic or regulatory authority, whichever occurs first. 
The study closure process is complete upon distribution of the Final Report or after final payments, 
whichever occurs last. Ongoing IRB/EC oversight is required until the overall study closure process is 
complete. Upon study closure, subjects should be managed and followed per physician discretion. 
16.10.2 
Early Termination or Suspension 
Early Termination is the closure of a clinical study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single site. Suspension is a temporary postponement of study activities 
related to enrollment and distribution of the product. This is possible for the whole study or a single 
site. In the event the whole study or a single site is terminated, subjects will be exited. 
16.10.2.1 
Study-wide termination or suspension 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• Adverse events associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• Observed/suspected performance different from the product’s design intent 
• Decision by Medtronic or regulatory body (where the study is operating under regulatory body 
authority) 
• Technical issues during the manufacturing process 

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16.10.2.2 
Investigator/study site termination or suspension 
Possible reasons for clinical investigator or site termination or suspension include but are not limited to: 
• Failure to obtain initial IRB/EC approval or annual renewal of the study 
• Persistent non-compliance to the clinical investigation (e.g. failure to adhere to inclusion/exclusion 
criteria, failure to follow subjects per scheduled follow-ups) 
• Lack of enrollment 
• Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring findings in a timely manner, etc.) 
• Institutional Review Board/Ethics Committee suspension of the site 
• Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 
• Investigator request (e.g. no longer able to support the study) 
16.10.3 
Procedures for Termination or Suspension 
16.10.3.1 
Medtronic-initiated and regulatory authority-initiated 
• Medtronic will promptly inform the clinical investigators of the (early) termination or suspension 
and the reasons and inform the regulatory authority(s) where required 
• In the case of study termination or suspension for reasons other than a temporary IRB/EC approval 
lapse, the investigator will promptly inform the IRB/EC 
• In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
16.10.3.2 
Investigator-initiated 
• The investigator will inform Medtronic and provide a detailed written explanation of the termination 
or suspension 
• The investigator will promptly inform the institution (where required per regulatory requirements) 
• The investigator will promptly inform the IRB/EC 
• The investigator will promptly inform the regulatory authorities (if required) 
• The investigator will promptly inform the subjects and/or the personal physician of the subjects to 
ensure appropriate care and follow-up is provided 
• In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
16.10.3.3 
Ethics Committee-initiated 
• The investigator will inform Medtronic and provide a detailed written explanation of the termination 
or suspension within 5 business days 
• The investigator will promptly inform the regulatory authorities (if required) 
• Subject enrollment must stop until the suspension is lifted 

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• Subjects already enrolled should continue to be followed in accordance with IRB/EC policy or its 
determination that an overriding safety concern or ethical issue is involved 
• The investigator will inform his/her institution (where required per local requirements) 
• The investigator will promptly inform the subjects, and/or the personal physician of the subjects, 
with the rationale for the study termination or suspension 
 
17. 
References 
 
 
1. 
Rabe K, Watz H, Chronic Obstructive Pulmonary Disease. The Lancet, Vol 389, Issue 10082, May 2017 
2. 
Ko, et. Al. Acute Exacerbation of COPD. Respirology. Circulation 2016 Oct;21(7):1152-65 
3. 
Earl S. Ford, Louise B. Murphy, Olga Khavjou, Wayne H. Giles, James B. Holt, and Janet B. Croft., Total and 
state-specific medical and absenteeism costs of COPD among adults aged ≥ 18 years in the United States 
for 2010 and projections through 2020, Chest, 147 (1), pp. 31-45 (January 2015) 
4. Abraham, William, et. al. Intrathoracic Impedance vs Daily Weight Monitoring for Predicting 
Worsening Heart Failure Events: Results of the Fluid Accumulation Status Trial (FAST). 
Congestive Heart Failure, Vol 17, Issue 2, March/April 2011. 
5. Adamson, et. al. Continuous Autonomic Assessment in patients with symptomatic heart failure: 
Prognostic Value of Heart Rate variability measured by an Implantable Cardiac 
Resynchronization Device, Circulation 110:2389-2394, 2004. 
6. Goetze, Stephan, et. al. Ambulatory respiratory rate trends identify patients at higher risk of 
worsening heart failure in implantable cardioverter defibrillator and biventricular device 
recipients: a novel ambulatory parameter to optimize heart failure management. J Inter Card 
Electrophysiol, 43:21-29, 2015. 
7. Katra, Rodolphe, Niranjan Chakravarthy, Remote At-Home Detection and Monitoring of 
Functional Chronotropic Incompetence in Heart Failure Patients. J of Cardiovasc Trans. Res. 
4:14-20, 2011. 
8. Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: 
correlation with fluid status and feasibility of early warning preceding hospitalization. 
Circulation 2005;112(6):841-8. 
9. Roy-Chaudhury, P, Williamson, DE, Tumlin, JA, Kher, VK, Prakash, K, Charytan DM, Tiwari, SC, 
Pokhariyal, S, Podoll, AS. “Monitoring in Dialysis (MiD) Study: Exploring the Timeline and 
Etiology of Increased Arrhythmias in Hemodialysis (HD) Patients.” J Am Soc Nephrol; 2015: Late 
Breaking Clinical Trial Poster (SA-PO1112). 
10. Ekman, I., et. al. Symptoms in patients with heart failure are prognostic predictors: insights from 
COMET. Journal of Cardiac Failure. 11, 288–292, 2005. 
11. Silva, L., et. al. Persistent orthopnea and the prognosis of patients in the heart failure clinic. 
Congestive Heart Failure, 10, 177–180, 2004. 
12. Pürerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR. Miniaturized 
Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 
2015 Jun;12(6):1113-9. 
13. Seemungal et. Al. Exacerbation rate, health status and mortality in COPD – a review of potential 
interventions, International Journal of COPD, 2009. 

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18. 
Appendices 
 
18.1 Informed Consent Template(s) 
Patient informed consent form templates will be provided under separate cover. 
18.2 Data Collection Elements (Electronic Case Report Forms) 
Electronic Case Report Forms for the LINQTM for COPD study will be provided under separate 
cover. Final eCRFs will be provided to sites via the electronic data management system after the 
site has fulfilled all requirements for database access. 
18.3 LINQTM for COPD Study Procedure Handbook 
A LINQ™ for COPD Study Procedure handbook that will provide instructions on the following: how 
to apply and utilize the DR220 Holter during the Spirometry tests, EMFIT Bed Monitor instructions, 
and Subject diary instructions will be provided under a separate cover. 
18.4 Participating Investigators and Institutions 
A complete list of participating investigators and institutions (including names, titles/professional 
positions, address(es), and telephone numbers) where study activities will be conducted will be 
distributed under a separate cover when available. Approval of the LINQTM for COPD Study CIP will 
be documented by signing the Clinical Trial Agreement or a separate investigator agreement. 
18.5 IRB Committee List 
A complete list of participating IRBs and the Chairperson(s) will be provided under separate cover. 
This information will be updated throughout the course of the study. The updated list will be 
maintained at Medtronic and will be available upon request. 
18.6 Committees 
The Reveal LINQ™ for COPD study will utilize an Event Adjudication Committee (EAC) for the 
assessment of Pulmonary related AEs and AEs with a fatal outcome. 
The Reveal LINQ™ for COPD study may utilize a Publication Committee aiming to manage study 
publications. 
A Data Monitoring Committee (DMC) is not needed for this study. This decision was made based 
on the following criteria: it is felt there are no additional benefits of a DMC reviewing the data in 
addition to the Event Adjudication Committee (EAC) 
The updated member lists will be maintained at Medtronic and will be made available upon request. 
18.7 Labeling 
Labeling for the investigational RAMware will be provided under separate cover. Labeling for all 
system components used in this study can be found with each package insert and/or will be 
available on http://manuals.medtronic.com. 

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19. 
Version History 
 
 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Not Applicable, New Document 
XXXXXXXX, Clinical Research 
Specialist 
XXXXXXXX, Sr. Principal 
Statistician 
2.0 
• 
Updated exclusion criteria 
• 
Inserted a max number of subjects per site that 
can utilize the EMFIT bed monitor 
• 
Clarified manual transmission requirements 
• 
Made minor formatting and grammar changes 
• 
Updated CIP title to Reveal LINQTM for COPD 
Study 
XXXXXXXX, Clinical Research 
Specialist 
3.0 
• 
Removed “electronic” when referencing to the 
subject diary 
• 
Added clarification regarding potential risks in 
section 10.1 
• 
Adjusted required manual transmissions to a bi- 
weekly basis 
XXXXXXXX, Clinical Research 
Specialist 
4.0 
• 
Updated I/E criteria 
• 
Added option of investigational ALLEVIATE-HF 
Software and RAMware 
• 
6-month in office visit changes: Made the visit to 
be optional and allowed it to be done in-office at 
any time during study participation, except within 
30 days post insertion of the device. Removed the 
BioPac system, 6-minute walk test and lab 
requirement. Added the tidal volume spirometry 
assessment accompanied with breathing 
maneuvers and Chest X-ray procedure 
• 
Allowed for prior spirometry results to be used at 
baseline visit if done in the past 6 months 
• 
Changed diary requirement to be weekly and 
when symptoms change 
• 
Changed laboratory collection requirement to 
either Brain natriuretic peptide (BNP) OR N- 
terminal brain natriuretic peptide (NT-proBNP) 
instead of requiring both 
XXXXXXXX Clinical Research 
Specialist 
XXXXXXXXXXXXXXX, Principal 
Statistician 
5.0 
• 
The CIP was transitioned to CIP template version 
E from version 3. 
XXXXXXXXXXXXXXXX, Clinical 
Research Specialist 

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• 
Updated the follow-up period to 6 months for the 
last patient enrolled and the expected total study 
duration to 33 months in section 4 (synopsis), 
section 7 (study design) and section 7.1 
(duration). 
• 
Updated figure 1 (study flowchart) to correspond 
to the follow-up period of 6 months. 
• 
Footer was added in section 3. Synopsis and 
section 9.4 Exclusion criteria to correspond to the 
Intended Study deviation dated 13-OCT-2021. 
• 
Sections (7.2 Manufacturer, 7.3 Packaging, 7.4 
Intended Population, 7.5 Product Use, 7.6 
Product Training Materials, 7.7 Shipment of Study 
Components, 7.8 Product Receipt and Tracking, 
7.9 Product Storage, 7.10 Product Return, 7.11 
Product Accountability, 8.1 Investigator/ 
Investigation Site Selection, 8.2 Study Site 
Activation, 8.3 Role of the Sponsor 
Representatives, 10.23.2 Study completed, 
10.23.4 Subject chooses to Exit, 10.23.5 
Investigator Withdraws Subject and 10.23.6 
Conditional Disengagement) were updated. 
• 
Scheduled follow up visits was updated in section 
10.12 
• 
Definition for Serious Health Threat (Section 12.4 
Definitions/Classifications (table 9)) was removed 
as this definition was incorrectly included in the 
CIP and it is not necessary as this study is not ISO 
compliant.