Post Approval Study of the remedē System
Conditions: Central Sleep Apnea
Sponsor: Respicardia, Inc.

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CLINICAL INVESTIGATIONAL PLAN 
Respicardia· 
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Document Name: 
Post Approval Study of the remede® System 
Clinical lnvestigational Plan 
Document#: 
CR1079 
Revision C 
Prospective, single arm cohort study to evaluate the long-term safety, 
long-term effectiveness, and survival rate in subjects implanted with 
the remede System 
Author: 
Scott McKane 
Print 
Chief Medical Officer: 
Robin Germany, MD 
Print 
Clinical Affairs: 
Linda Nelson 
Print 
Regulatory/Quality: 
Kevin Bentley 
Print 
Research & Development:
Todd Goblish 
Print 
Revision History 
Rev 
Description. of Change 
A 
Initial Release 
B 
Clarified definitions of study objectives, added PSG 
requirement at 60-month follow-up visit. 
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Clinical lnvestigational Plan - Post Approval Study 
CR1079, Rev C - Signature Page 
Respicardia, Inc. Confidential 
Page 1 of 1 
ClinicalTrials.gov identifier: NCT03425188

12400 Whitewater Drive 
Suite 150 
Minnetonka, MN 55343 
Phone: 952.540.4470    Fax: 952.540.4485 
Clinical Investigational Plan – Post Approval Study 
Respicardia, Inc. Confidential 
CR1079, Rev C – PI Signature Page 
Page 1 of 1 
Post Approval Study of the remedē® System 
Clinical Investigational Plan 
Prospective, single arm cohort study to evaluate the long-term safety, 
long-term effectiveness, and survival rate in subjects implanted with the 
remedē System  
Contact: 
Linda Nelson 
VP of Clinical Affairs 
Respicardia, Inc. 
12400 Whitewater Drive 
Suite 150 
Minnetonka, MN  55343 
+1-952-540-4479
Principal Investigator 
Print name 
Signature 
Date 

12400 Whitewater Drive 
Suite 150 
Minnetonka, MN 55343 
Phone: 952.540.4470    Fax: 952.540.4485 
Clinical Investigational Plan – Post Approval Study 
Respicardia, Inc. Confidential 
CR1079, Rev C  
Page 1 of 44 
Post Approval Study of the remedē® System 
Clinical Investigational Plan 
Prospective, single arm cohort study to evaluate the long-term safety, 
long-term effectiveness, and survival rate in subjects implanted with the 
remedē System  
Contact: 
Linda Nelson 
VP of Clinical Affairs 
Respicardia, Inc. 
12400 Whitewater Drive 
Suite 150 
Minnetonka, MN  55343 
+1-952-540-4479

Clinical Investigational Plan – Post Approval Study 
Respicardia, Inc. Confidential 
CR1079, Rev C  
Page 2 of 44 
Table of Contents 
1 
PROTOCOL SYNOPSIS ................................................................................................ 4 
2 
STUDY PURPOSE AND JUSTIFICATION .................................................................... 4 
3 
STUDY MILESTONES AND TIMELINE ......................................................................... 4 
4 
BACKGROUND ............................................................................................................. 5 
4.1 
Regulatory History ............................................................................................ 5 
5 
DEVICE NAME, INTENDED USE, AND SYSTEM DESCRIPTION ................................ 5 
5.1 
Device Name .................................................................................................... 5 
5.2 
Indications for Use ............................................................................................ 5 
5.3 
System Overview .............................................................................................. 5 
6 
STUDY DESIGN AND SCOPE ...................................................................................... 6 
7 
STUDY OBJECTIVES ................................................................................................... 6 
8 
SUBJECT SELECTION ................................................................................................. 7 
8.1 
Inclusion Criteria ............................................................................................... 7 
8.2 
Exclusion Criteria .............................................................................................. 7 
9 
INVESTIGATIVE SITE INFORMATION ......................................................................... 8 
9.1 
Investigative Site Selection ............................................................................... 8 
9.2 
Ethical Considerations ...................................................................................... 8 
9.3 
Activation Requirements ................................................................................... 8 
9.4 
Informed Consent ............................................................................................. 9 
9.5 
Study Training ................................................................................................... 9 
9.6 
Study Suspension or Termination ..................................................................... 9 
10 STUDY PROCEDURES ............................................................................................... 10 
10.1 30, 42, and 54 Month Follow-up ...................................................................... 12 
10.2 36 and 48 Month Follow-up ............................................................................. 12 
10.3 60 Month Follow-up......................................................................................... 12 
10.4 Interim Device Management ........................................................................... 13 
10.5 System Modifications ...................................................................................... 13 
10.6 Study Exit ........................................................................................................ 14 
10.6.1 
Subject Lost to Follow Up .................................................................... 14 
10.6.2 
Subject-Initiated Withdrawal ................................................................ 14 
10.6.3 
Physician-Initiated Withdrawal ............................................................. 14 
10.6.4 
Subject Death ...................................................................................... 14 
10.7 Protocol Deviations ......................................................................................... 15 

 
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10.8 Adverse Events ............................................................................................... 15 
10.8.1 
Safety Endpoint Definitions .................................................................. 18 
10.8.2 
Serious Adverse Event Reporting ........................................................ 18 
10.9 Concomitant Cardiac Devices ......................................................................... 18 
10.10 
Technical Observations .................................................................... 19 
11 STATISTICAL METHODS ........................................................................................... 19 
11.1 General Statistical Considerations .................................................................. 19 
11.2 Analysis Population ......................................................................................... 19 
11.3 Data Analyses ................................................................................................. 19 
11.4 Sample Size Justification ................................................................................ 20 
12 DATA MANAGEMENT ................................................................................................ 20 
13 MONITORING .............................................................................................................. 20 
14 RECORD RETENTION AND REPORTS ..................................................................... 21 
15 INSURANCE ................................................................................................................ 24 
APPENDIX A: SAMPLE INFORMED CONSENT ............................................................... 25 
APPENDIX B: QUALITY OF LIFE QUESTIONNAIRE ........................................................ 35 
APPENDIX C: PLANNED DATA COLLECTION LIST OF DATA VARIABLES ON CASE 
REPORT FORMS (CRFS) .................................................................................................. 36 
APPENDIX D: ACRONYMS/ABBREVIATIONS/GLOSSARY ............................................ 42 
APPENDIX E: BIBLIOGRAPHY ......................................................................................... 43 
APPENDIX F: REMEDĒ SYSTEM IMPLANT AND CLINICIAN USE MANUAL ................. 44 
 
Table of Tables 
Table 1 
Follow-up Schedule.........................................................................................11 
Table 2 
Investigator Reporting Requirements ..............................................................22 
Table 3 
Sponsor Reporting Requirements ...................................................................23 
 
 
 
 

 
Clinical Investigational Plan – Post Approval Study 
 
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1 
PROTOCOL SYNOPSIS 
This Post Approval Study is a multi-center, prospective, open label, single arm cohort study 
to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects 
implanted with the remedē System from the remedē System Pivotal Trial. Up to 94 subjects 
will be enrolled at up to 21 sites in the United States (US) and five (5) sites in the European 
Union (EU). 
Only subjects who were implanted and actively being followed as part of the remedē System 
Pivotal Trial are eligible for this trial.  
An individual subject’s participation is expected to continue to five years post remedē 
System implant. Subjects will start follow-up at the appropriate follow-up visit based on their 
initial remedē System implant date. Subjects will be seen for an in-office visit at  36, 48, and 
60 months post implant for a remedē System assessment, an assessment of medical stability, 
sleep study (polygram [PG] at 36- and 48-month visits and polysomnogram [PSG] at the 60-
month visit), Epworth Sleepiness Scale (ESS) completion, and adverse event monitoring. 
Subjects will be contacted by phone at 30, 42, and 54 months post implant for survival and 
adverse event monitoring. 
Data analyses will include an evaluation of long-term safety, long-term effectiveness, and 
survival rate. 
2 
STUDY PURPOSE AND JUSTIFICATION 
This extended follow-up study is a Food and Drug Administration (FDA) condition of 
approval of the remedē System in adult patients with moderate to severe central sleep apnea 
(CSA). The primary purpose of this prospective, multicenter, single arm cohort study is to 
evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted 
with the remedē System in the remedē System Pivotal Trial. 
3 
STUDY MILESTONES AND TIMELINE 
Following FDA approval of the protocol, remedē System Pivotal Trial sites with active 
subjects will be invited to participate in this study. Activation of sites should be complete 
within six months following FDA approval of the protocol. Enrollment of subjects, defined 
as signing the informed consent, should be complete within six months following site 
activation. 
Follow-up is planned for five years from the date of implant. Since all subjects have already 
completed 24 months of follow-up, total study duration is estimated to be three years. 

 
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4 
BACKGROUND 
4.1 
Regulatory History 
The remedē System Pivotal Trial demonstrated that remedē System therapy effectively 
treats CSA and delivers statistically significant and clinically meaningful improvements in 
sleep, respiratory, and patient-centered metrics. The primary effectiveness endpoint of the 
remedē System Pivotal Trial was met: a significantly higher proportion of subjects in the 
treatment group (35 of 68, 51%) had a 50% or higher reduction in Apnea-Hypopnea Index 
(AHI) from baseline to 6 months of follow-up than in the control group (8 of 73, 11%). The 
difference between groups was 41% (p ≤.0001). This significant difference demonstrated the 
superiority of remedē System therapy compared to no therapy. In the per protocol 
population, 60% of the Treatment subjects achieved a ≥50% reduction in AHI versus 11% in 
the Control group. The benefits experienced by the Treatment group continued throughout 
the course of the study, demonstrating durability of effect, and were confirmed by the results 
of the Control group after 6 months of active therapy. In addition to the benefits conferred by 
meeting the primary effectiveness endpoint, all of the hierarchically tested secondary 
endpoints (Central Apnea Index [CAI], AHI, Oxygen Desaturation Index 4% [ODI4], percent 
sleep time in Rapid Eye Movement [REM], Patient Global Assessment [PGA], Arousal 
Index [ArI], and ESS) were met. The therapy was well tolerated, and 91% of subjects were 
free from serious adverse events (SAEs) related to the implant procedure, remedē System, or 
delivered therapy through 12 months indicating both procedural and chronic safety of the 
remedē System. 
The remedē System received CE Mark approval on August 13, 2010. 
The remedē System was approved for marketing in the US by the FDA on October 6, 2017. 
As a condition of approval, the Post Approval Study will continue to gather clinical evidence 
regarding the safety and effectiveness for the remedē System in adult subjects with moderate 
to severe CSA.  
5 
DEVICE NAME, INTENDED USE, AND SYSTEM DESCRIPTION 
5.1 
Device Name 
The remedē® System  
5.2 
Indications for Use 
The remedē System is an implantable phrenic nerve stimulator indicated for the treatment of 
moderate to severe CSA in adult patients. 
5.3 
System Overview 
The system consists of an implantable pulse generator (IPG), one transvenous lead to 
stimulate the phrenic nerve, and one transvenous sensing lead to sense respiration via 

 
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transthoracic impedance. External, non-implanted devices and accessories of the remedē 
System include the remedē System programmer, external IPG, and programming wand. A 
detailed description of the remedē System can be found in the remedē System Implant and 
Clinician Use Manual found in Appendix F. 
6 
STUDY DESIGN AND SCOPE 
This is a multi-center, prospective, open label, single cohort study to evaluate the long-term 
safety, long-term effectiveness, and survival rate in subjects implanted with the remedē 
System in the remedē System Pivotal Trial. Up to 94 subjects will be enrolled at up to 21 US 
sites and 5 EU sites. 
Only subjects who were implanted and actively being followed as part of the remedē System 
Pivotal Trial are eligible for this trial.  
An individual subject’s participation is expected to continue through five years post remedē 
System implant. Subjects will be seen for an in-office visit at  36, 48, and 60 months post 
implant for a remedē System assessment, an assessment of medical stability, sleep study 
(polygram [PG] at 36- and 48-month visits and polysomnogram [PSG] at the 60-month visit), 
Epworth Sleepiness Scale (ESS) completion, and adverse event monitoring. Subjects will be 
contacted by phone at 30, 42, and 54 months post implant for survival and adverse event 
monitoring. See Table 1 Follow-up Schedule. 
7 
STUDY OBJECTIVES 
1. Evaluate the survival rate  
This endpoint is an assessment of survival in subjects with moderate to severe 
CSA being treated with the remedē System. Survival will be compared to 
historical controls or newly published results at three and five years post implant. 
No formal statistical hypothesis will be tested.  
2. Evaluate long-term three and five-year device-related Serious Adverse Events 
(SAEs)  
This endpoint is an assessment of long-term safety via summary of anticipated or 
unanticipated device-related SAEs. Events must meet the definition of serious as 
defined in Section 10.8. Device-related SAEs include device explants due to 
device-related infection and events such as: device malfunction, lead fracture, 
lead component failure, lead dislodgment, lead displacement, pocket perforation, 
or extra-respiratory sensation requiring lead revision. remedē System IPG 
replacement for battery depletion will not be considered a device-related SAE 
unless it is earlier than anticipated. The number of events and subjects with an 

 
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event will be summarized through each time point. No formal statistical 
hypothesis will be tested. 
3. Evaluate long-term three and five-year therapy-related SAEs 
This endpoint assesses the safety of the remedē System by evaluating anticipated 
or unanticipated therapy-related SAEs. Therapy-related SAEs must meet the 
definition of a SAE as defined in Section 10.8 and include events such as 
diaphragmatic stimulation discomfort, extra-respiratory stimulation, or 
concomitant device interaction. The number of events and subjects with an event 
will be summarized through each time point. No formal statistical hypothesis will 
be tested. 
4. Evaluate the AHI, CAI, and obstructive apnea index (OAI) at three years using in-
home polygram (PG) and at five years using  in-lab polysomnogram (PSG) 
This effectiveness endpoint will be assessed by summarizing the AHI, CAI, and 
OAI at three and five years, as well as change from baseline at five years. No 
formal statistical hypothesis will be tested. 
5. Evaluate the change in quality of life from baseline to three and five years using 
the ESS  
The ESS is a validated instrument that assesses a subject’s daytime sleepiness. 
The objective is to demonstrate a reduction in the ESS score from baseline at 
three and five years. No formal statistical hypothesis will be tested. 
8 
SUBJECT SELECTION 
8.1 
Inclusion Criteria 
1. Subjects who were previously implanted with the remedē System and participated 
in the remedē System Pivotal Trial  
2. In the investigator’s opinion, willing and able to comply with all study 
requirements 
3. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) 
approved informed consent (including Health Insurance Portability and 
Accountability Act [HIPAA] authorization in the US) 
8.2 
Exclusion Criteria 
There are no criteria by which a subject would be excluded. 

 
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9 
INVESTIGATIVE SITE INFORMATION 
9.1 
Investigative Site Selection 
Sites will be selected for participation based on the following criteria: 
• Previous participation in the remedē System Pivotal Trial with currently active 
subjects 
• Sufficient resources within site to conduct follow-up requirements of all subjects 
• Willingness and interest in conducting the study 
At each of the participating sites, it is expected that there will be coordination among the 
cardiac physician, interventional cardiologist / electrophysiologist, and the sleep medicine 
physician. The Principal Investigator (PI) is responsible for the overall conduct of the study. 
The PI may train and designate person(s) to conduct study-related activities but must retain 
overall responsibility for the trial. All training and delegation of tasks will be documented. 
9.2 
Ethical Considerations 
The study will be conducted according to the Declaration of Helsinki, Protection of Human 
Subjects (21 Code of Federal Regulations [CFR] 50), IRBs (21 CFR 56), Financial 
Disclosure by Clinical Investigators (21 CFR Part 54), Electronic Records and Electronic 
Signatures (21 CFR Part 11), Obligations of Clinical Investigators (21 CFR 312), The 
International Standard for Standardization (ISO) 14155:2011, and in accordance with local 
laws and regulations in each of the countries participating. 
9.3 
Activation Requirements 
This protocol and any amendments will be submitted to the FDA, appropriate regulatory 
bodies and IRB/IEC for approval to conduct the study prior to initiation. 
The study will not commence at a participating institution until all investigational site 
activation requirements are completed. These include: 
• Clinical Trial Agreement (signed) 
• IRB/IEC approval letter (and national regulatory approval if required) 
• Respicardia, Inc. and IRB/IEC-approved informed consent form (ICF) (and national 
regulatory approval if required) 
• Completed Delegation of Authority Form/Delegation of Responsibilities Form 
• Training Documentation Form(s) completed for PI, study coordinator, and any other 
study site personnel completing trial-related activities at the time of activation. 
• PI Curriculum Vitae (CV) and sub-investigators’ CVs participating at the time of 
activation 
• Clinical Investigational Plan (CIP) signed by the PI  
• IRB/IEC membership list/roster or Assurance Document 

 
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• Financial disclosure from the PI and sub-investigators participating at the time of 
activation 
9.4 
Informed Consent 
Consent forms will be submitted with the protocol for review and approval by the IRB/IEC 
by the study site. 
All subjects for this study will be provided an IRB/IEC-approved consent form describing 
this study and will be provided sufficient information to make an informed decision about 
their participation in this study.  
The formal consent of a subject, will be obtained before that subject is submitted to any study 
procedure that is not standard of care. Consent forms must be signed by the subject or legal 
representative, and the investigator-designated research professional obtaining the consent. 
Respicardia, Inc. and the IRB/IEC must approve alternative informed consent materials prior 
to use. Where applicable, a local language informed consent will be provided. 
9.5 
Study Training 
Protocol-specific training and education customized to the specific roles of all investigational 
site personnel will take place prior to site personnel participating in the study and throughout 
the study as needed. In particular, all physicians delegated to implant the remedē System will 
be trained on standardized procedures for system implantation prior to being authorized to 
perform remedē System modifications or have training documents on file  from the remedē 
System Pivotal Trial. All training will be documented and filed in the regulatory binder at the 
respective investigational site as well as at Respicardia, Inc. All study personnel, including 
new study personnel added during the course of the study, must be trained and delegated 
prior to performing any study-related activities considered non-standard of care. 
9.6 
Study Suspension or Termination 
A study suspension is a temporary postponement of some or all of the study activities 
whereas termination of the study indicates study closure. Study suspension or termination of 
the study may occur at a single investigational site or for the study as a whole. Possible 
reasons for considering suspension or early termination include, but are not limited to, the 
following: 
• Study Suspension or Early Termination 
o Adverse events associated with the remedē System may endanger the safety 
or welfare of the study subjects 
o Observed and / or suspected performance of the remedē System that is 
different from the product’s design intent or specifications in a manner 
deemed unacceptable 

 
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• Early Individual Investigational Site Termination or Suspension: 
o Investigational site’s noncompliance to the CIP or failure to comply with the 
country or local regulations 
o Failure to submit data in a timely manner 
o Failure to follow-up on monitoring findings 
o IRB/IEC approval expiration or withdrawal 
o Lack of PI oversight 
o All subjects at the site have completed participation in the trial 
o Fraud or fraudulent misconduct is discovered (as defined by local laws and 
regulations) 
If a study suspension occurs, study subjects who are enrolled and implanted will continue to 
be followed for safety evaluation and/or per regulatory requirements. 
10 
STUDY PROCEDURES 
Scheduled assessments at each visit are listed below and in Table 1. Subjects will start 
follow-up at the appropriate follow-up visit based on their initial remedē System implant 
date. Subjects are required to complete the informed consent process prior to participation in 
the study. 
 

 
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Table 1 
Follow-up Schedule 
 
Months1 Post Implant 
 
Assessment 
Follow-up window (days) 
Prior to 
first visit 
30 
(phone) 
±60 days 
36 
(office) 
±60 days 
42 
(phone) 
±60 days 
48 
(office) 
±60 days 
54 
(phone) 
±60 days 
60 
(Office) 
±60 days 
Interim 
Device  
Management 
System 
Modification 
Study 
Exit 
Informed Consent 
X 
 
 
 
 
 
 
 
remedē System assessment 
 
 
X 
 
X 
 
X 
O 
 
 
Subject status 
 
X 
X 
X 
X 
X 
X 
 
 
X 
Adverse event review and reporting 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical stability2 
 
 
X 
 
X 
 
X 
 
 
 
In-home PG 
 
 
X 
 
X 
 
 
O 
 
 
In-lab PSG 
 
 
 
 
 
 
X 
O 
 
 
ESS 
 
 
X 
 
X 
 
X 
 
 
 
Concomitant device interaction testing, 
if applicable 
 
 
 
 
 
 
 
O3 
X 
 
X=Required at visit, O=Collected/performed as needed 
1 A month is defined as 30 days for visit target date determinations 
2 Perform medical stability assessment prior to PG/PSG 
3 Concomitant device interaction testing should be repeated prior to therapy initiation and anytime the remedē System or the cardiac device system is modified if applicable 

 
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10.1 30, 42, and 54 Month Follow-up 
The following assessments will be performed via telephone call: 
• Survival 
• Adverse event review and reporting 
o Review events with subject and review medical records since last visit 
10.2 36 and 48 Month Follow-up 
The following assessments will be performed at a clinic office visit: 
• Date of visit  
• remedē System assessment including 
o stimulation lead impedance and capture levels on final programmed electrode 
pair  
o unipolar stimulation lead impedance measurements 
o interrogation including pre and post device settings parameter printouts  
• Medical stability assessment prior to PG (defined as no hospitalizations in the 
previous 2 weeks) 
o The PG should not be performed until the subject is medically stable for at 
least 2 weeks 
• In-home PG 
o PG is set up in the office and subject is instructed on proper use 
o Must include a minimum of four hours of high quality recording time 
• ESS 
• Adverse event review and reporting 
o Review events with subject and review medical records since last visit 
10.3 60 Month Follow-up 
The following assessments will be performed at a clinic office visit: 
• Date of visit  
• remedē System assessment including 
o stimulation lead impedance and capture levels on final programmed electrode 
pair  
o unipolar stimulation lead impedance measurements 
o interrogation including pre and post device settings parameter printouts  
• Medical stability assessment prior to PSG (defined as no hospitalizations in the 
previous 2 weeks) 
o The PSG should not be performed until the subject is medically stable for at 
least 2 weeks 
 
 

 
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• PSG in sleep laboratory 
o Must include a minimum of four hours of high quality recording time 
including a minimum of 2 hours of sleep  
• ESS 
• Adverse event review and reporting 
o Review events with subject and review medical records since last visit 
• Exit the subject from the trial following completion of the visit 
10.4 Interim Device Management  
The investigator may evaluate the remedē System at any point during the study via office 
visit, in-home PG, or in-lab PSG. The remedē System Implant and Clinician Use Manual 
should be used by the Investigator or designee to guide the programming options and remedē 
System set up. Respicardia, Inc. personnel may also be available for technical and 
programming support. 
The following assessments should be performed and recorded at an interim device 
management visit: 
• Adverse Event review and reporting 
o Review events with subject and review medical records since last visit 
• remedē System assessment (optional) 
o stimulation lead impedance and capture levels on final programmed electrode 
pair  
o interrogation including pre and post device settings parameter printouts  
If applicable, concomitant device interaction testing should be repeated prior to therapy 
initiation and anytime the remedē System or the cardiac device system is modified as 
described in the remedē System Implant and Clinician Use Manual.  
10.5 System Modifications 
In the event the remedē System requires modification (i.e., lead repositioning or 
replacement, system explant, or IPG replacement) the following assessments should be 
performed: 
• Adverse Event review and reporting 
o Review events with subject and review medical records since last visit 
• Concomitant device interaction testing, if applicable 
In addition, system modifications occurring after exit from the pivotal trial and prior to 
signing ICF in this trial will be collected. 
 
 

 
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10.6 Study Exit 
If the study exit occurs prior to the 60 Month follow-up visit, the following assessments will 
be performed: 
• Adverse event review and reporting 
o Review events with subject and review medical records since last visit 
In addition to subject’s exit at study closure or completion of protocol requirements, subjects 
may be exited from the study for the following reasons and their exit documented on a Study 
Exit Case Report Form (CRF): 
• Subject lost to follow-up 
• Subject-initiated withdrawal 
• Physician-initiated withdrawal 
• Subject death 
10.6.1 Subject Lost to Follow Up  
In the event the ICF is signed and the subject is lost to follow-up, the study site must make a 
minimum of two attempts (one certified letter and one documented phone call or two 
certified letters) to contact the subject. Each attempt to contact a lost to follow-up subject and 
the method used will be documented in the subject’s medical record. 
10.6.2 Subject-Initiated Withdrawal 
A subject may withdraw from the study at any time by notifying their physician. If a subject 
withdraws participation in the study at any time, there will be no penalty or loss of future 
medical care. 
10.6.3 Physician-Initiated Withdrawal 
The PI may withdraw the subject from the study without the subject’s consent at any time if 
medically justified or for other documented reasons.  
10.6.4 Subject Death 
Subject deaths must be reported to Respicardia or designee within 24 hours of investigator 
knowledge, and the site must also complete an Adverse Event CRF. 
If a subject death occurs while the subject is in the hospital, submit a copy of the hospital 
discharge note(s) and/or progress note(s) related to the death and/or death summary to 
Respicardia, Inc. If an autopsy is performed, submit a copy of the autopsy report and once 
the death certificate becomes available, send a copy to the Sponsor within 10 days. If a 
subject death occurs at a site remote from the investigational site, it is the investigative site’s 
responsibility to make an attempt to retrieve all pertinent information related to the subject’s 
death and submit the PI’s summary of the known events surrounding the death. In all cases 

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following subject death, the investigator should request that the remedē System be explanted 
and returned to Respicardia, Inc. 
10.7 Protocol Deviations 
A protocol deviation is defined as an instance(s) of failure to follow, intentionally or 
unintentionally, the requirements of the CIP, including the Investigator Agreement, IRB/IEC, 
or local regulatory requirements. 
The PI must maintain accurate, complete and current records, including documents showing 
the dates of and reasons for each deviation from the protocol. Protocol deviations must be 
reported to Respicardia, Inc. regardless of whether or not medically justifiable. In the event 
the deviation involved 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 
Respicardia, Inc. and the IRB/IEC within 5 working days of the deviation occurring. All 
other deviation reporting to IRB/IEC must comply with local IRB/IEC and local regulatory 
requirements. 
Respicardia, Inc. will be responsible for analyzing, assessing and trending deviations to 
determine if corrective or preventive action is required. All deviations will be reported in the 
progress and final study reports. 
10.8 Adverse Events 
All adverse events (AEs) that occur between the subject signing the ICF and study exit will 
be documented in a timely manner and reported to the Sponsor. The investigator at the site 
should follow AEs until they have resolved, the condition has stabilized, or the subject exits 
the trial and report such follow-up information to the sponsor. AEs will be recorded in detail 
on the AE CRF. 
In addition, serious AEs, implant-related AEs, therapy-related AEs, and device-related AEs 
occurring after exit from the pivotal trial and prior to signing ICF in this trial will be 
collected. 
An independent Clinical Events Committee (CEC) will adjudicate, at minimum, all serious 
adverse events, including deaths, and therapy-, device- or implant-related adverse events.  
CEC membership will include at least one physician from each of the following specialties: 
sleep, cardiology (preferably heart failure), and electrophysiology (familiarity with device 
implant procedures). 
Definitions and Classifications 
Adverse event (AE): Any untoward medical occurrence,  unintended disease or injury, or 
untoward clinical sign (including abnormal laboratory findings) in subjects, users or other 

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persons, or resulting in abandonment of remedē System therapy, whether or not related to the 
remedē System or study procedures. For users or other persons, this definition is restricted to 
events related to the remedē System.  
Procedure-related:  An adverse event (whether serious or not) that occurs due to any 
procedure required to implant, revise, or explant the remedē System. 
Device-related:  An adverse event (whether serious or not) that is related to the remedē 
System and includes device explant due to device-related infection and events such as: 
device malfunction, lead fracture, lead component failure, lead dislodgment, lead 
displacement, pocket perforation, or extra-respiratory sensation requiring lead revision.  
Battery depletion within an expected timeframe and resulting IPG replacement will be 
reported as a system modification and not an adverse event, unless the battery depletion 
occurred earlier than expected in which case it will also be recorded as an AE.   
Therapy-related:  An adverse event (whether serious or not) that includes events such as 
diaphragmatic stimulation discomfort, extra-respiratory stimulation, or concomitant device 
interaction. 
Anticipated Adverse Event:  An adverse event for which the nature, severity, or degree of 
incidence is known and identified in the product labeling or CIP.  
Possible adverse effects include, but are not limited to, the following: 
Implant Procedure-Related  
•
Adverse contrast dye reaction such as allergic reaction, pulmonary edema, or
worsening renal function
•
Adverse reaction to radiation exposure
•
Thromboembolism
•
Air embolism
•
Bleeding
•
Cardiac perforation including tamponade
•
Hematoma, seroma, local bruising or swelling
•
Hypotension
•
Local wound healing issues at device implant site including wound dehiscence,
pocket erosion, extrusion, movement of implanted device, keloid formation
•
Pneumothorax
•
Hemothorax
•
Vascular damage, e.g., venous dissection, perforation

 
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Lead and System-Related  
• Adverse biocompatibility reaction to the implanted system  
• Infection 
• Lead breakage  
• Lead dislodgement  
• Lead not connected or secured appropriately in device header 
• Implantable device malfunction 
• Requirement for more energy to stimulate the nerve or ineffective stimulation 
• Venous occlusion 
Therapy-Related 
• Crosstalk with another implanted device  
• Disrupted sleep 
• Muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate 
stimulation 
• Nerve dysfunction 
• Perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea 
• Inappropriate sensations 
• Worsening heart failure, respiratory status or overall health  
Other Procedure, System or Therapy-Related 
• Anxiety 
• Arrhythmia, including ventricular fibrillation 
• Death 
• Depression 
• Hypotension 
• Pain 
• Skin irritation or local allergic reaction 
• Thrombus or embolism, potentially leading to pulmonary embolism or stroke 
Serious Adverse Event (SAE): Any adverse event as defined above (whether anticipated or 
unanticipated) that: 
• led to a death,  
• led to a serious deterioration in the health of the subject that 
o resulted in a life-threatening illness or injury, 
o resulted in a permanent impairment of a body structure or a body function, 
o required inpatient hospitalization or prolongation of existing hospitalization,  
o resulted in medical or surgical intervention to prevent permanent impairment 
to body structure or a body function, or 
• led to fetal distress, fetal death or a congenital abnormality or birth defect 
 

 
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In addition, the following will be considered an SAE for purposes of  this trial: 
• A device or therapy related AE that required a system modification (excluding IPG 
replacement for battery depletion within anticipated timeframe or elective explant)  
Unanticipated Adverse Device Effect (UADE): any serious adverse effect on the health or 
safety or any life-threatening problem or death caused by, or associated with, a device 
(remedē System), if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the product labeling, or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects. 
Investigators must report any suspected UADE to the sponsor as soon as possible but no later 
than ten (10) working days of knowledge of the event. Respicardia, or designee, will report 
results of any UADE evaluation to FDA and to all reviewing IRBs/IECs and participating 
investigators within ten (10) working days after Respicardia first receives notice of the effect.  
10.8.1 Safety Endpoint Definitions  
Serious device-related:  For the purpose of assessing the device-related safety endpoint, a 
serious device-related adverse event is an event that meets the definition of serious and 
includes device explant due to device-related infection and events such as:  device 
malfunction, lead fracture, lead component failure, lead dislodgment, lead displacement, 
pocket perforation, or extra-respiratory sensation requiring lead revision.  
Serious therapy-related:  For the purpose of assessing the therapy-related safety endpoint, 
the event must meet the definition of serious and include events such as diaphragmatic 
stimulation discomfort, extra-respiratory stimulation, or concomitant device interaction. 
10.8.2 Serious Adverse Event Reporting 
Any SAE must be reported to the Sponsor within 24 hours of investigational site knowledge. 
If the SAE requires expedited reporting to regulatory bodies (for example, a UADE resulting 
in death), the Sponsor will complete reporting requirements to FDA and other applicable 
regulatory bodies, as well as all reviewing IRBs and participating investigators within 10 
working days after the Sponsor first receives notice of the event. The Sponsor will submit 
additional reports as requested from the FDA concerning the reported event.  
10.9 Concomitant Cardiac Devices 
Any addition of or change to a concomitant cardiac device during this trial or occurring after 
exit from the pivotal trial and prior to signing ICF for the post approval study will be 
collected. 
 

 
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10.10 Technical Observations 
A technical observation is defined as a deficiency related to the identity, quality, durability, 
reliability, safety, effectiveness or performance of a device after it has been released for 
distribution. 
All technical observations that occur between the subject signing the ICF and study exit will 
be documented in a timely manner and reported to the Sponsor. Technical observations will 
be recorded on the technical observation CRF. 
11 
STATISTICAL METHODS 
11.1 General Statistical Considerations 
Data from this study will be combined with data from the remedē System Pivotal Trial. All 
subjects will be pooled for analysis regardless of original randomization assignment. 
Descriptive statistics will be used to summarize data. Continuous variables will be 
summarized using means, standard deviations, medians, interquartile ranges, minimums and 
maximums. Categorical variables will be summarized by calculating the percent of subjects 
in each category. No imputation for missing data will be performed. 
Statistical analyses will be performed using validated software (e.g., SAS). 
Copies of databases used to prepare clinical report summaries will be archived to enable any 
statistical analyses performed to be replicated. 
11.2 Analysis Population 
Intention-to-Treat (ITT):   Subjects who were previously consented and randomized in the 
remedē System Pivotal Trial. All effectiveness and safety evaluations will be based on the 
ITT population. Effectiveness analyses will only include subjects with data at the visit of 
interest. 
11.3 Data Analyses 
All subjects randomized in the remedē System Pivotal Trial will be included in the safety 
assessments, unless otherwise noted. All adverse events will be summarized by seriousness, 
relatedness, and temporal relationship to the procedure and will be analyzed in a descriptive 
fashion. The number of events and number of subjects experiencing events will be 
summarized. 
The survival distribution will be estimated with a Kaplan-Meier curve and the 95% 
confidence interval for the three and five year (or other time point of interest) survival rates 
will be calculated using the standard error determined by the Peto method.1 The survival rate 
will be compared to historical controls and/or newly published results.  

 
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Subjects with follow-up data at the visit of interest will be included in the effectiveness 
assessments. Change from baseline analyses will include subjects with baseline and follow-
up visit data.  
Additional exploratory and/or subgroup analyses may also be performed to characterize 
study outcomes. 
11.4 Sample Size Justification 
No sample size calculations were performed. 
12 
DATA MANAGEMENT 
Clinical data will be captured on CRFs and reported to Respicardia, Inc. CRF elements can 
be found in Appendix C. Device and sleep study data will be collected at applicable 
protocol-required visits in addition to source documentation collected for AE review and 
adjudication. All data should be entered into the CRFs, reviewed, and approved by the 
Investigator in a timely manner after the study visit or adverse event occurs. 
In order to protect subject confidentiality, subjects will be identified by a subject ID number. 
The subject ID will be the same ID number that was assigned in the remedē System Pivotal 
Trial.  
All clinical data not collected via CRF (i.e., interrogation including pre and post device 
settings parameter printouts) should be uploaded to the Sponsor via a secure web portal. 
Sleep study data from the 36, 48, and 60 month post implant follow-up visits will be 
submitted directly to the core lab for analysis. Core Lab personnel will review the sleep 
studies per the 2007 American Academy of Sleep Association Manual (AASM) and provide 
the data to Respicardia, Inc. A sleep study report will be provided to the respective 
investigational site. The intent of providing the report is to document study procedure 
compliance and CRF completion; it is not to assist in patient care. The study site should have 
the sleep study read locally if needed for timely patient care.  
All study documents must be retained by the investigational site for a period of two years 
after study conclusion and made available for monitoring or auditing by the sponsor’s 
representative or representatives of the FDA and other applicable regulatory agencies. The 
investigator must ensure the availability of source documents from which the information on 
the CRFs was derived. 
13 
MONITORING 
Each investigational site will be monitored to ensure compliance with the signed investigator 
agreement, CIP, IRB/IEC reporting requirements, and the applicable regulatory 
requirements. Monitoring will be conducted by the Sponsor or designee. The monitor will 

 
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verify that the study records are adequately maintained and the data is complete and reported 
in a timely matter. Monitoring may occur via an on-site visit or remotely.  
Additional details regarding the monitoring process will be defined in the Monitoring Plan. 
14 
RECORD RETENTION AND REPORTS 
The investigator is responsible for the preparation (review and signature) and/or retention of 
the records below. The following records are subject to inspection and must be retained for a 
period of two years after the date on which the study is terminated or completed. In Europe, 
records must be retained per local regulations. 
• All correspondence that pertains to the investigation 
• CV of the principal Principal Investigator and sub-investigators 
• Signed and dated Clinical Trial Agreement and compensation records 
• Subject’s case history records, including: signed/dated subject ICF, all relevant 
observations of adverse device effects, medical history, exposure to the system under 
study, and documentation of the dates and rationale for any deviation from the CIP or 
Investigator Agreement 
• The Clinical Investigational Plan 
• IRB/IEC approval documents (with documentation that the investigator did not 
participate in the approval process) 
• Monitoring Log 
• Any other records that local regulatory agencies require to be maintained 
Table 2 summarizes the minimum reporting requirements for the investigator. The 
investigator is responsible for the preparation (review and signature) and submission to 
Respicardia, Inc. of all CRFs, reportable AEs, deaths, and deviations from the CIP. If any 
action is taken by an IRB/IEC with respect to the investigation, the information must be 
forwarded to Respicardia, Inc. Reports are subject to inspection and to the retention 
requirements as described above for investigator records. The investigator shall prepare and 
submit all required reports in a complete, accurate and timely manner. 
 
 

 
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Table 2 
Investigator Reporting Requirements 
Report 
Investigator 
Prepares Report 
For 
Reporting Requirements and Timeframe  
Unanticipated Adverse 
Device Effects (UADEs) 
Sponsor and 
IRB/IEC 
Notification to Respicardia or designee, as soon as 
possible but no later than 10 working days after 
investigators are first aware of the effect. 
Medical Device Report 
(MDR) 
FDA and Sponsor 
Investigators may report to the FDA when they learn that 
any of their devices may have caused or contributed to a 
death or serious injury. Investigator may also report to the 
FDA when they become aware that their device has 
malfunctioned and would be likely to cause or contribute 
to a death or serious injury if the malfunction were to 
recur. 
Vigilance Reporting (EU 
only) 
Sponsor 
Notification to Sponsor of an Incident as soon as possible. 
An Incident is defined as: “Any malfunction or 
deterioration in the characteristics and/or performance of 
a device, as well as any inadequacy in the labeling or the 
instructions for use which, directly or indirectly, might 
lead to or might have led to the death of a patient, or 
USER or of other persons or to a serious deterioration in 
their state of health.” 
Serious Adverse Events 
Sponsor and 
IRB/IEC and 
applicable regulatory 
authorities 
Notification to Sponsor and IRB/IEC within 24 hours 
after investigators are first aware of the event. 
Withdrawal of IRB/IEC 
approval or other action on 
part of the IRB that impacts 
study 
Sponsor 
An investigator shall report to the sponsor, within 5 
working days, a withdrawal of approval by the reviewing 
IRB of the investigator's part of an investigation.  
Lack of informed consent 
Sponsor and 
IRB/IEC 
If an investigator uses a device without obtaining 
informed consent, the investigator shall report such use to 
the sponsor and the reviewing IRB within 5 working days 
after the use occurs. 
Deviations from 
Investigational Plan 
Sponsor and 
IRB/IEC 
 
An investigator shall notify the sponsor and the reviewing 
IRB of any deviation from the investigational plan to 
protect the life or physical well-being of a subject in an 
emergency. Such notice shall be given as soon as 
possible, but in no event later than 5 working days after 
the emergency occurred. Except in such an emergency, 
prior approval by the sponsor is required for changes in or 
deviations from a plan, and if these changes or deviations 
may affect the scientific soundness of the plan or the 
rights, safety, or welfare of human subjects, FDA and 
IRB approval in accordance with 812.35(a) also is 
required. 
Progress Reports  
Sponsor and 
IRB/IEC 
An investigator shall submit progress reports on the 
investigation to the sponsor, the monitor, and the 
reviewing IRB at regular intervals, but in no event less 
often than yearly. 

 
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Table 2 
Investigator Reporting Requirements 
Report 
Investigator 
Prepares Report 
For 
Reporting Requirements and Timeframe  
Final Report 
Sponsor and 
IRB/IEC 
The investigator shall, within 3 months after termination 
or completion of the investigation or the investigator’s 
part of the investigation, submit a final report to the 
Sponsor and the reviewing IRB/IEC and/or appropriate 
national regulatory authorities. 
 
Table 3 summarizes Respicardia’s reporting requirements relative to study findings and 
progress. 
 
Table 3 
Sponsor Reporting Requirements 
Report 
Sponsor Prepares 
Report For 
Reporting Requirements and Timeframe  
Unanticipated Adverse 
Device Effects  
Investigators, 
IRBs/IECs and FDA 
Within 10 working days from the time the Sponsor first 
learns of the effect. 
Serious Adverse Events 
requiring expedited reporting 
Investigators, 
IRBs/IECs and FDA 
Within 10 working days from the time the Sponsor first 
learns of the event. 
Withdrawal of IRB/IEC 
approval or other action on 
part of the IRB that impacts 
study 
Investigators, FDA, 
and European 
Competent Authorities 
(CAs) 
Within 5 working days after receipt of the withdrawal of 
approval. 
Medical Device Report 
(MDR) 
Sponsor 
Manufacturers are required to report to the FDA when 
they learn that any of their devices may have caused or 
contributed to a death or serious injury. Manufacturers 
must also report to the FDA when they become aware that 
their device has malfunctioned and would be likely to 
cause or contribute to a death or serious injury if the 
malfunction were to recur. 
Vigilance Reporting (EU 
only) 
Local CA and Notified 
Body 
Notification to Sponsor of an Incident as soon as possible. 
An Incident is defined as: “Any malfunction or 
deterioration in the characteristics and/or performance of 
a device, as well as any inadequacy in the labeling or the 
instructions for use which, directly or indirectly, might 
lead to or might have led to the death of a patient, or 
USER or of other persons or to a serious deterioration in 
their state of health.” 
Lack of informed consent 
FDA and European 
CAs where applicable 
Investigator’s report submitted within 5 working days of 
notification. 
Progress Reports  
 
Investigators,  FDA, 
and European CAs 
where applicable 
Every 6 months for the first two years of the study and 
annually, thereafter. 
Final Report 
Investigators, FDA, 
and IRBs/IECs 
Within 6 months of study closure. 

 
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Table 3 
Sponsor Reporting Requirements 
Report 
Sponsor Prepares 
Report For 
Reporting Requirements and Timeframe  
Withdrawal of FDA approval 
Investigators and FDA 
Within 5 working days after receipt of notice of the 
withdrawal of approval. 
Recall and device disposition 
FDA,IRBs/IECs, 
European CAs, and 
Notified Body 
Any request that an investigator return, repair, or 
otherwise dispose of any units of a device within 30 
working days after request and stating why the request 
was made. 
 
15 
INSURANCE 
Respicardia, Inc. has obtained local insurance within and outside of the US as required by 
law for the purpose of conducting this trial. 
 

 
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APPENDIX A: SAMPLE INFORMED CONSENT 
 
 

 
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RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
 
 
TITLE: 
Post Approval Study of the remedē® System 
 
PROTOCOL NO.: 
Respicardia CR1079 
 
 
SPONSOR: 
Respicardia, Inc. 
 
Minnetonka, Minnesota 
 
United States 
 
 
INVESTIGATOR: 
[Name] 
 
[Address] 
 
[City, State, Zip Code] 
 
[Country] 
 
 
STUDY-RELATED 
PHONE NUMBER(S): 
[Name] 
 
[Phone Number(s)] 
 
A person who takes part in a research study is called a research or study subject. In this 
consent form “you” always refers to the research subject. If you are a legally authorized 
representative, please remember that “you” means the research (study) subject. 
 
SUMMARY 
You are being asked to be in a research study. The purpose of this consent form is to help 
you decide if you want to be in a research study. 
 
You should not sign this consent form until all of your questions are answered. 
 
Things to know before deciding to take part in a research study: 
• The main goal of a research study is to learn things to help patients in the future. 
• The main goal of regular medical care is to help each patient. 
• The decision to join or not to join the research study will not cause you to lose any 
medical benefits. If you decide not to take part in this study, your doctor will continue 
to treat you. 
• Your medical records may become part of the research record. If that happens, your 
medical records may be looked at and/or copied by the sponsor of this study and 
government agencies or other groups associated with the study. 

 
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• Your medical insurance may be billed for any standard medical care you receive 
during the research study. If your insurance company is billed then it may have access 
to the research records. Insurance companies may not pay for treatment that is part of 
a research study.  
 
PURPOSE AND BACKGROUND 
The purpose of this study is to assess the continued safety and effectiveness of this approved 
device.  
 
The remedē System Pivotal Trial showed that remedē System benefits patients with central 
sleep apnea. Based on these results, the FDA approved the remedē System for sale in the 
United States (US). As part of the approval, the FDA is requiring the sponsor to conduct this 
post-approval study.  
 
There are no experimental (investigational) procedures or devices involved in this study. 
 
STUDY PROCEDURES 
If you agree to take part in this study, the study doctor and study staff will collect information 
about you. They may ask you questions, and they may review your medical records to obtain 
health information. 
 
Your participation in this study may last up to 36 months. Up to 94 subjects will take part in 
this study, which is being conducted at up to 26 sites worldwide. 
 
You will be asked about serious health problems, problems related to the remedē System, 
and any new or changes to your cardiac device (if you have one)  that you have experienced 
since you exited the remedē System Pivotal Trial.  
 
This study requires annual office visits at 36, 48, and 60 months after your remedē System 
was implanted. It is possible that you have already completed some of these visits while 
enrolled in the remedē System Pivotal Trial. If you consent to be in this study, your first visit 
will be calculated based on the date of your original implant of the remedē System. For 
example, if you were implanted in January of 2014 and sign consent in January of 2018, your 
first visit would be considered your 48 month visit or 54 month visit depending on the visits 
you completed in the remedē System Pivotal Trial. Your final visit will be at 60 months post 
remedē System implant. 
 
During the 36 and 48 month office visits, you will have the following assessments: 
 

 
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• a remedē System device evaluation (a wand is placed over the skin where the device 
is located and it reports its condition electronically) 
• an in home, overnight sleep study  
• a quality of life questionnaire asking how sleepy you are during the daytime 
• review of new or worsening health problems, hospitalizations, illness or injury, or 
outpatient procedures that you have experienced 
 
During the 60 month office visit, which is your last visit, you will have the following 
assessments:  
 
• a remedē System device evaluation (a wand is placed over the skin where the device 
is located and it reports its condition electronically) 
• an overnight sleep study done in a sleep laboratory  
• a quality of life questionnaire asking how sleepy you are during the daytime 
• review of new or worsening health problems, hospitalizations, illness or injury, or 
outpatient procedures that you have experienced 
 
At the time of these annual visits, if you were hospitalized within the two weeks prior to the 
visit, you will be asked to delay the sleep study until it has been at least two weeks since your 
hospitalization or your doctor determines you are stable enough to perform the sleep study.  
 
Telephone visits will be conducted in between the annual office visits at 30, 42, and 54 
months. During these calls, your health status will be determined by review of new or 
worsening health problems, hospitalizations, illness or injury, or outpatient procedures that 
you have experienced since your last office visit.  
 
If you have other stimulation devices implanted or modified during the study, contact your 
study doctor as special testing will be needed to ensure the devices are not interacting. 
 
If you die when you are in the study, your emergency contact or next of kin may be contacted 
to inquire about the cause of your death. An attempt may be made to collect the remedē 
System if it is explanted. 
 
ROLE OF SPONSOR REPRESENTATIVE 
Respicardia, Inc. personnel may be present at office visits for technical and programming 
support. 
RISKS AND DISCOMFORTS 
There are no research-related risks to you by allowing your study doctor to continue to 
collect information about you and the remedē System.  

 
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NEW INFORMATION  
You will be told about any new information that might change your decision to be in this 
study. You may be asked to sign a new consent form if this occurs. 
 
BENEFITS 
Your central sleep apnea may improve while you are in this study. The results of this study 
may help people with central sleep apnea in the future. 
 
COSTS 
Now that the FDA has approved the remedē System, follow-up care will be considered 
standard of care. Respicardia, Inc. (Sponsor) will no longer be paying for procedures related 
to the remedē System such as lead revisions, replacement of the battery, explant (removal) of 
the remedē System, or routine follow-up visits. The reason the Sponsor is no longer paying 
for these procedures is that they are now considered standard of care and will be billed to 
appropriate third party payors, such as your insurance carrier or Medicare. The usual costs 
connected with the device procedures will normally be covered by your health insurance. 
You will be responsible for any co-pays, co-insurance or deductibles you would normally 
pay. If you have any questions about your health insurance, or possible expenses, please talk 
with the study doctor and your health insurer or Medicare. 
 
PAYMENT FOR PARTICIPATION 
You will not be paid for being in this study. 
 
ALTERNATIVE TREATMENT 
This is not a treatment study. Your alternative is not to be in this study. 
 
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH 
PURPOSES  
[Use the following authorization format if the site is collecting health information, is a 
covered entity under HIPAA and is not using a separate HIPAA authorization form. 
 
If the site is not collecting health information, is not a covered entity under HIPAA or is 
using a separate HIPAA authorization form, use the “Confidentiality” text that follows, 
rather than the authorization text below. 
 
California sites: This entire HIPAA section plus authorization statement should be placed at 
the end of the consent form following a page break and must include its own set of signature 
lines.] 

 
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What information may be used and given to others? 
The study doctor will get your personal and medical information. For example:  
 
• Past and present medical records 
• Research records 
• Records about phone calls made as part of this research 
• Records about your study visits 
 
Who may use and give out information about you? 
The study doctor and the study staff.  
 
Who might get this information? 
The sponsor of this research. “Sponsor” means any persons or companies that are: 
• working for or with the sponsor, or  
• owned by the sponsor. 
 
Your information may be given to:  
• The U.S. Food and Drug Administration (FDA), 
• Department of Health and Human Services (DHHS) agencies, 
• Governmental agencies in other countries, 
• Governmental agencies to whom certain diseases (reportable diseases) must be reported, 
and 
• [IRB Name] 
[Add any institutional names above IRB Name.] 
 
Why will this information be used and/or given to others? 
• to do the research,  
• to study the results, and  
• to see if the research was done right.  
 
If the results of this study are made public, information that identifies you will not be used. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
May I review or copy my information? 
Yes, but only after the research is over.  
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. 

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[or] 
This permission will be good until [date] [required in CA, DE, IN, IL, WA, and WI]. 
You may withdraw or take away your permission to use and disclose your health information 
at any time. You do this by sending written notice to the study doctor. If you withdraw your 
permission, you will not be able to stay in this study. 
When you withdraw your permission, no new health information identifying you will be 
gathered after that date. Information that has already been gathered may still be used and 
given to others.  
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your permission. 
[Use the following confidentiality text if the site is not collecting health information, is not a 
covered entity under HIPAA,or is using a separate HIPAA authorization form.] 
Confidentiality  
Information from this study will be given to the sponsor. “Sponsor” includes any persons or 
companies that are contracted by the sponsor to have access to the research information during 
and after the study. 
The information will also be given to the U.S. Food and Drug Administration (FDA). It may be 
given to governmental agencies in other countries where the study device may be considered for 
approval. Medical records which identify you and the consent form signed by you will be 
looked at and/or copied for research or regulatory purposes by: 
•
the sponsor,
•
[CRO name], an agent for the sponsor,
and may be looked at and/or copied for research or regulatory purposes by: 
•
the FDA,
•
Department of Health and Human Services (DHHS) agencies,
•
governmental agencies in other countries, and
•
[IRB Name]
[Add any institutional names above IRB name]
Absolute confidentiality cannot be guaranteed because of the need to give information to these 
parties. The results of this research study may be presented at meetings or in publications. Your 
identity will not be disclosed in those presentations. 

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If you approve, your personal physician will be informed of your participation in the clinical 
study. 
COMPENSATION FOR INJURY 
For this study, we are only collecting information about you and your remedē System. 
However, if you believe that an injury has occurred, call your study doctor immediately. If 
you need any medical treatment, it will be provided. Your insurance will be billed for this 
treatment. No monetary compensation or subsidized medical treatment will be routinely 
provided to you by any person involved in this study including the study doctors, the 
hospital, or the study sponsor. If there is a defect in your remedē System, the standard terms 
and conditions of the product warranty will apply. 
VOLUNTARY PARTICIPATION/WITHDRAWAL 
Your participation is voluntary. You may decide not to participate or may leave the study at 
any time. Your decision will not result in any penalty or loss of benefits to which you are 
entitled. 
Your participation in this study may be stopped at any time by the study doctor or the 
sponsor without your consent for any reason, including: 
•
if it is in your best interest
•
you do not consent to continue in the study after being told of changes in the research
that may affect you
•
or for any other reason
If you leave the study before the planned final visit, you may be asked by the study doctor to 
have some tests or procedures done so that you leave the study safely. 
SOURCE OF FUNDING 
Funding for this research study will be provided by Respicardia, Inc. 
QUESTIONS 
Discuss with your study doctor any questions, concerns, or complaints which you may have 
regarding your participation in this study or if you have experienced a research-related injury. 
If you have any questions, contact: 

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Page 33 of 44 
NAME 
TITLE/POSITION 
PHONE 
[PI Name] 
Study Doctor 
[Coordinator Name] 
Study Coordinator 
If you have any questions about your rights as a research subject or if you have questions, 
concerns, or complaints about the research, you should contact: 
[IRB Contact Information] 
[IRB name] is a group of people who independently review research. 
[IRB name] will not be able to answer some study-specific questions, such as questions about 
appointment times. However, you may contact IRB name] if the research staff cannot be 
reached or if you wish to talk to someone other than the research staff. 
Do not sign this consent form unless you have had a chance to ask questions and have 
received satisfactory answers to all of your questions. 
If you agree to be in this study, you will receive a signed and dated copy of this consent form 
for your records. 
A description of this clinical study will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at any 
time. 

 
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CONSENT 
 I voluntarily agree to participate in this clinical investigation and to follow the 
investigator’s instructions. 
 If I refuse to participate, I will incur no penalties. 
 I may discontinue the study at any time without incurring any penalties. 
 I acknowledge the information provided to me about the study and all of my questions 
have been answered. 
 I agree, or my legally authorized representative agrees, to the use of my personal data for 
purposes of the study. 
 I agree, or my legally authorized representative agrees, that the sponsor’s representatives, 
regulatory authorities, Ethics Committees or Internal Review Boards representatives may 
be granted direct access to my medical records. 
 I understand that I will receive a copy of this form. 
 
 
 
 
Printed Name of Subject 
 
 
 
 
 
 
Signature of Subject or of Subject’s Legally Authorized Representative 
Date 
 
 
 
 
 
Printed Name of Subject’s Legally Authorized Representative (if applicable) 
 
 
I have explained the Post Approval Study to the study subject, and I have answered all 
questions about this research to the best of my ability. A signed copy of this consent form has 
been provided to the study subject. 
 
 
 
 
Printed Name of Person Conducting Informed Consent Discussion  
 
 
 
 
 
 
Signature of Person Conducting Informed Consent Discussion  
Date 
 
 

 
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APPENDIX B: QUALITY OF LIFE QUESTIONNAIRE 
The following standardized, validated tool will be used to assess Quality of Life.  
 

 
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APPENDIX C: PLANNED DATA COLLECTION LIST OF DATA VARIABLES ON CASE 
REPORT FORMS (CRFs) 
 
• Enrollment  CRF 
o Date of consent 
o Protocol Version active at the time of consent If subject is currently receiving 
therapy from the remedē System 
o Original implant date 
• Visit CRF 
o Did subject complete visit? 
 If yes, type of visit 
• office or phone call 
• Date of visit or phone call 
 If no 
• Date of last contact 
• remedē System assessment CRF 
o Was capture threshold successfully obtained? 
o If no, select reason 
o If yes,  
 Date tested 
 Final programmed pair 
• Lead 
o Left 
o Right 
• Anode 
• Cathode 
• Lead Impedance 
• Current weak 
• Current strong 
• Pulse width 
• Frequency  
 Unipolar Stimulation Lead Impedance Measurements 
• 1-Can 
• 2-Can 
• 3-Can 
• 4-Can 
• 5-Can (if applicable) 
• 6-Can (if applicable) 
 Therapy mode at end of visit 
• Interim Device Management CRF 

 
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o Same information as remedē System assessment, if testing is performed 
• Adverse Event CRF 
o Onset date  
o Event type  
 New event 
 Update to event reported in Pivotal Trial 
o Event number 
o Diagnosis of event or symptoms if no diagnosis  
o Event description 
o Sponsor Event code 
o Relation to device 
 Definitely 
 Probably 
 Possibly  
 None 
• If related to device or therapy, which component 
o Therapy delivered by remedē System 
o Stimulation Lead 
o Sensing lead 
o IPG (excludes early battery depletion) 
o Early battery depletion 
o Other, specify:___________ 
o Relation to procedure 
 Definitely 
 Probably 
 Possibly 
 None 
o Treatment provided 
 Medication administered 
 Surgical procedure 
• If yes, specify: _______________ 
 remedē System programming 
 Concomitant device programming 
 Other, specify 
o Serious adverse event (Yes/No). If yes: 
 Led to Death 
 Resulted in a life-threatening illness or injury 
 Resulted in medical or surgical intervention to prevent permanent  
 
impairment to body structure or a body function 

 
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 Required inpatient hospitalization or prolongation of existing  
 
 
hospitalization 
• Date of admission 
• Date of discharge 
 Resulted in permanent impairment of a body structure or a body 
function 
 Led to fetal distress, fetal death or a congenital abnormality or birth 
defect 
 A device or therapy related AE that required a system modification 
(excluding IPG replacement for battery depletion within anticipated 
timeframe or elective explant) 
o Unanticipated adverse device effect 
o Adverse event status 
 Resolved 
• Date of Resolution 
 Ongoing, expect eventual resolution 
 Ongoing, stable or chronic condition 
 Death 
 Unknown 
• Technical Observation CRF 
o Date of observation 
o Product 
 Physician Programmer 
•  
 Programming wand 
 IPG 
 External IPG 
 Stimulation Lead 
 Therapy delivered by remedē System 
 respiguideTM 
 Other 
o Model (if applicable) 
o Serial number (if applicable) 
o Comments 
• Sleep Study CRF 
o Date 
o Was the subject medically stable? 
o Type of Sleep Study 
 PG 
 PSG 

 
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o Total recording time 
o AHI 
o CAI 
o OAI 
o MAI 
o HI 
o Was the subject receiving remedē System therapy? 
o Was the subject using concomitant sleep disordered breathing therapy? 
 If yes, select all that apply 
• CPAP 
• Oxygen 
• ASV 
• Bi-PAP  
• Dental appliance 
• Other, specify:__________ 
• Epworth Sleepiness Scale (ESS) CRF  
o Was ESS completed (Yes,/No). If yes: 
 Date 
 Question responses 
• Concomitant Cardiac Device CRF 
o Reason for procedure  
 New device 
 Upgrade to new device type 
 Replacement of device 
 Other, specify 
o Date or procedure 
o Type of device 
o Manufacturer and model number 
o Location of device 
o Was interaction testing performed? 
 Date of testing 
• System Modification CRF 
o Date 
o Primary reason for system modification 
o Modifications to remedē System 
 IPG 
• Not modified 
• Repositioned 
• Replaced 
o Manufacturer, Model, Serial Number 

 
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• Explanted (without replacement) 
 Stimulation Lead 
• Not modified 
• Repositioned 
• Replaced 
o Manufacturer, Model, Serial Number 
• Capped with replacement 
o Manufacturer, Model, Serial Number 
• Capped without replacement 
• Explanted (without replacement) 
 Sensing Lead 
• Not applicable 
• Not modified  
• Repositioned 
• Replaced 
o Manufacturer, Model, Serial Number 
• Capped with replacement 
o Manufacturer, Model, Serial Number 
• Capped without replacement 
• Explanted (without replacement) 
o Was system functional following procedure? 
 If no, Reason 
 If yes, Therapy mode 
 If yes, Was interaction testing performed 
• Protocol Deviation CRF 
o Date of deviation 
o Visit deviation applies to  
o Type of deviation 
 Visit not performed 
 Visit out of window 
 Assessment out of window 
 Required assessment(s) not done 
• Specify:_________________ 
 Assessment by untrained / not delegated staff 
 Informed Consent 
 Other, specify:_________________________ 
o Describe the deviation:_____________________ 
o Reason for deviation 
• Study Exit CRF 
o Date of study exit 

 
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o Reason for study exit 
 Subject completed study follow-up requirements 
 Subject Lost to Follow-up 
 Subject-Initiated Withdrawal 
 Physician-Initiated Withdrawal 
 Subject Death 
 
Early termination of site or study 
o If lost to follow-up, subject or physician initiated withdrawal or early 
termination: Date of last contact  
 
 

 
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Page 42 of 44 
APPENDIX D: ACRONYMS/ABBREVIATIONS/GLOSSARY 
 
AE 
 
 
Adverse Event 
AHI 
 
 
Apnea Hypopnea Index 
ArI 
 
 
Arousal Index 
CA 
 
 
Competent Authority 
CAI 
 
 
Central Apnea Index 
CEC 
 
 
Clinical Events Committee 
CFR 
 
 
Code of Federal Regulations 
CIP 
 
 
Clinical Investigational Plan 
CRF 
 
 
Case Report Form 
CSA  
 
Central Sleep Apnea 
CV 
 
 
Curriculum Vitae 
CVA  
 
Cerebrovascular Accident 
EC 
 
 
Ethics Committee 
ESS 
 
 
Epworth Sleepiness Scale 
EU 
 
 
European Union 
FDA  
 
Food and Drug Administration 
HIPAA 
 
Health Insurance Portability and Accountability Act 
ICF 
 
 
Informed Consent Form 
IPG 
 
 
Implantable Pulse Generator 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intention-to-Treat 
IEC 
 
 
Independent Ethics Committee 
OAI 
 
 
Obstructive Apnea Index 
ODI4  
 
Oxygen Desaturation Index 4% 
PGA  
 
Patient Global Assessment 
PI 
 
 
Primary Investigator 
PSG 
 
 
Polysomnogram 
PG 
 
 
Polygram 
REM  
 
Rapid Eye Movements 
SAE 
 
 
Serious Adverse Event 
UADE  
 
Unanticipated Adverse Device Effect 
US 
 
 
United States 
 
 
 

Clinical Investigational Plan – Post Approval Study 
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Page 43 of 44 
APPENDIX E: BIBLIOGRAPHY 
1. Survivorship analysis for clinical studies. Eugene K. Harris and Adelin Albert,
Marcel Dekker, New York, 1991.

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CR1079, Rev C 
Page 44 of 44 
APPENDIX F: remedē System Implant and Clinician Use Manual 

 
 
 
 
 
remedē® System 
System Implant and Clinician Use Manual 
 
 
 
 
 
remedē® Implantable Pulse Generator Model 1001 
remedē® System Programmer Model 1002A 
remedē® System Programming Wand Models 1004A, 1004A–F  
remedē® External IPG Model 1006  
respistim® L Stimulation Lead Models 2001, 2002, 2003, 2004 
respistim® LQ Stimulation Lead Models 5045, 5055, 5065, 5085 
respistim® LQS Stimulation Lead Models 4045, 4055, 4065, 4085 
respistim® R Stimulation Lead Models 3101, 3102, 3103, 3104, 3105, 3106, 3201, 3202, 
3203, 3204, 3205, 3206 
 
 
 

 
2 
TABLE OF CONTENTS 
TABLE OF CONTENTS ....................................................................................................... 2 
LIST OF TABLES .................................................................................................................. 4 
LIST OF FIGURES ................................................................................................................ 5 
1.1 
Symbols Used on Product or Package Labeling ............................................... 6 
1.2 
Introduction ....................................................................................................... 8 
1.3 
Indications for Use ............................................................................................ 8 
1.4 
System Overview .............................................................................................. 8 
1.5 
Description of System Components.................................................................. 8 
1.5.1 
remedē® IPG ................................................................................... 8 
1.5.2 
respistim® Stimulation Leads .......................................................... 9 
1.5.3 
Respiratory Sensing Lead ............................................................. 10 
1.5.4 
remedē® System Programmer ....................................................... 10 
1.5.5 
remedē® Programming Wand ....................................................... 11 
1.5.6 
remedē® External IPG ................................................................... 11 
1.6 
Contraindications ............................................................................................ 11 
1.7 
Warnings and Precautions............................................................................... 12 
1.7.1 
Warnings ....................................................................................... 12 
1.7.2 
General Precautions ...................................................................... 15 
1.7.3 
Home or Work Environment Precautions ..................................... 15 
1.7.4 
remedē® System Therapy Hazards ............................................... 16 
1.8 
Adverse Effects ............................................................................................... 17 
1.9 
Clinical Data Summary ................................................................................... 18 
1.9.1 
Pivotal Trial of the remedē System ............................................... 18 
1.9.2 
Patients Studied ............................................................................. 18 
1.9.3 
Study Design and Methods ........................................................... 19 
1.9.4 
Study Results ................................................................................ 20 
1.10 
Storage and Handling ...................................................................................... 27 
1.10.1 
Stimulation Leads ......................................................................... 28 
1.11 
Clinician Training ........................................................................................... 28 
1.12 
remedē® System Implant................................................................................. 28 
1.12.1 
Mitigation Strategies for Managing the Risk of Infection During 
remedē System Implant, Replacement and Explant Procedures ... 29 
1.12.2 
Implantable System ....................................................................... 29 

 
3 
1.12.3 
remedē® System Implant Procedure ............................................. 29 
1.12.4 
Concomitant Cardiac Device Testing (if applicable) .................... 36 
1.12.5 
Postoperative Care ........................................................................ 37 
1.12.6 
Physician Instructions to Patient ................................................... 37 
1.12.7 
Patient Registration ....................................................................... 38 
1.12.8 
Surgical Revision and Explant ...................................................... 38 
1.13 
Using the remedē® System Programmer ........................................................ 39 
1.13.1 
remedē® System Programmer ....................................................... 39 
1.13.2 
Preparing for a Clinical Programming Session ............................. 41 
1.14 
remedē® System Limited Warranty ................................................................ 48 
1.15 
Appendix I: remedē® System IPG Specifications ........................................... 52 
1.15.1 
Physical Characteristics ................................................................ 52 
1.15.2 
Lead Connectors ........................................................................... 52 
1.15.3 
Radiopaque Identification ............................................................. 52 
1.15.4 
Battery Information ....................................................................... 53 
1.15.5 
Programmable Settings ................................................................. 54 
1.16 
Appendix II: respistim® L, LQ, and LQS Stimulation Lead Specifications ... 57 
1.16.1 
Physical Characteristics ................................................................ 57 
1.17 
Appendix III: respistim® R Lead Specifications ............................................. 58 
1.17.1 
Physical Characteristics ................................................................ 58 
1.18 
Appendix IV: Additional Programmer and eIPG Details ............................... 59 
1.18.1 
Power Supply ................................................................................ 59 
1.18.2 
Routine Cleaning .......................................................................... 59 
1.18.3 
Cybersecurity Considerations ....................................................... 59 
1.18.4 
eIPG Cable .................................................................................... 59 
1.19 
Appendix V: remedē® System Programmer Electromagnetic Interference 
Information ..................................................................................................... 60 
1.20 
Appendix VI: remedē® System Programmer Communications & Telemetry 64 
1.20.1 
Telemetry Data.............................................................................. 64 
1.20.2 
Troubleshooting ............................................................................ 64 
1.21 
Appendix VII: Service and Disposal Information .......................................... 66 
1.21.1 
Service........................................................................................... 66 
1.21.2 
Disposal......................................................................................... 66 
 
 

4 
LIST OF TABLES 
Table 1 
Baseline Demographics .................................................................................. 19 
Table 2 
Summary of Freedom from Related SAEs through 12 Month Visit (ITT) ..... 20 
Table 3 
Summary of Serious Adverse Events by Relation to Implant Procedure, 
remedē System, or Delivered Therapy through 12 Months ........................... 21 
Table 4 
Summary of Related non-Serious Adverse Events and Observations through 
12 Months ....................................................................................................... 23 
Table 5 
Summary of System Explants ......................................................................... 25 
Table 6 
Summary of Reasons for Trial Withdrawals .................................................. 25 
Table 7 
Summary of the Comparison of the Proportion of Patients with ≥ 50% 
Reduction in AHI at 6 Months (Modified ITT) .............................................. 27 
Table 8 
Environmental Temperature Limits ................................................................ 28 
Table 9 
Recommended Stimulation Threshold and Impedance Values ...................... 32 
Table 10 
remedē Software Application Toolbar Icons ................................................. 43 
Table 11 
remedē System IPG (Model 1001) Physical Description............................... 52 
Table 12 
remedē System IPG (Model 1001) Battery Information ................................ 53 
Table 13 
remedē System IPG (Model 1001) – Battery Longevity Estimates ............... 53 
Table 14 
remedē System IPG (Model 1001) Programmable Settings .......................... 54 
Table 15 
respistim L, LQ, and LQS Lead Model Descriptions ..................................... 57 
Table 16 
respistim R Model Descriptions ..................................................................... 58 
Table 17 
Electromagnetic Emissions Guidance Declaration ......................................... 60 
Table 18 
Electromagnetic Immunity Guidance Declaration .......................................... 61 
Table 19 
Electromagnetic Immunity Guidance Declaration .......................................... 62 
Table 20 
Recommended Separation Distances Between Portable and Mobile RF 
Communications Equipment ........................................................................... 63 
Table 21 
Telemetry Transmission Characteristics ......................................................... 64 

5 
LIST OF FIGURES 
Figure 1 
The remedē System IPG ................................................................................... 9 
Figure 2 
The remedē IPG Connector Ports..................................................................... 9 
Figure 3 
The remedē System Programmer ................................................................... 10 
Figure 4 
The remedē Programming Wand (Model 1004A) ......................................... 11 
Figure 5 
The remedē External IPG ............................................................................... 11 
Figure 6 
Typical Left Pericardiophrenic Vein Anatomy ............................................... 30 
Figure 7 
Recommended IPG Pocket Location .............................................................. 34 
Figure 8 
The remedē IPG Connector Block and Port Diagram .................................... 34 
Figure 9 
respistim L Stimulation Lead Connections .................................................... 35 
Figure 10 
respistim LQ and LQS Stimulation Lead Connections .................................. 35 
Figure 11 
respistim R Stimulation Lead Connections .................................................... 35 
Figure 12 
Proper Rotation of IPG to Wrap Excess Lead Length .................................... 36 
Figure 13 
remedē System Programmer Tablet Display (Model 1002A) ........................ 39 
Figure 14 
remedē System Programmer Tablet Display .................................................. 40 
Figure 15 
The remedē System Programmer Wand......................................................... 40 
Figure 16 
The remedē Software Application Icon ......................................................... 42 
Figure 17 
remedē Software Application Screen ............................................................. 42 
Figure 18 
Interrogate Button ........................................................................................... 45 
Figure 19 
remedē System Programmer Wand Urgent Off Button ................................. 46 
Figure 20 
remedē System IPG Radiopaque Identifier .................................................... 52 

 
6 
1.1 
Symbols Used on Product or Package Labeling 
Refer to individual product for applicable symbols. 
 
 
Applies to U.S. audiences only 
 
Catalog or Reference Number 
 
Lot Number 
 
Sterilized using ethylene-oxide gas 
 
Sterile Lot Number 
 
Do Not Reuse/Single Use Only 
 
Do Not Resterilize 
 
Temperature Limitation/Temperature Range 
 
Caution 
 
MR Unsafe 
 
Use by/Expiration date 
 
Date of Manufacture 

 
7 
 
Manufacturer 
 
Quantity in Package 
 
Inside Diameter 
 
Outside Diameter 
 
Length 
 
Consult Instructions for Use 
 
Keep away from heat and keep dry 
 
Type B Applied Part – No electrical connection to patient and 
may be grounded 
 
Type BF Applied Part – Electrically connected to patient but not 
directly to the heart 
 
Type CF Applied Part – Electrically connected to the heart of the 
patient 
 
Non-ionizing electromagnetic radiation 
 
Federal Communications Commission notice (USA) 
 
Conformité Européne (European Conformity). This system fully 
complies with the European Union Council Directive 
90/385/EEC 
 
Use by prescription only 

 
8 
1.2 
Introduction 
This manual is intended to provide clinicians with information regarding the implant and use 
of the remedē® System. Included in this manual are descriptions of the remedē System as 
well as instructions for handling, storing and surgical placement of the remedē System. This 
manual also includes an overview of the remedē System therapy and instruction for clinical 
use and follow-up care of patients using the remedē System Programmer. 
1.3 
Indications for Use 
The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment 
of moderate to severe central sleep apnea (CSA) in adult patients. 
1.4 
System Overview 
The system consists of an implantable pulse generator (IPG), one transvenous lead to 
stimulate the phrenic nerve, and one transvenous sensing lead to sense respiration via 
transthoracic impedance. External, non-implanted devices and accessories of the remedē 
System include the remedē System Programmer, external IPG, and programming wand. 
1.5 
Description of System Components 
All implanted components of the remedē System are intended for single use only. 
1.5.1 
remedē® IPG 
The remedē IPG (Model 1001, Figure 1) is an implantable, multi-programmable stimulator 
designed for unilateral, transvenous phrenic nerve stimulation. The device monitors the 
patient’s respiratory signals and provides electrical stimulation to the left or right phrenic 
nerve to restore patients to a normal breathing pattern during sleep. The remedē IPG contains 
electronic circuitry components and a battery, which are hermetically sealed in a titanium 
case. Therapy settings are determined by the physician and configured using an external 
programmer via telemetry. 
The remedē IPG has four 3.2 mm connector ports (Figure 2) that are compatible with IS-1 
connectors. The IS-1 lead connectors in each 3.2 mm connector port are secured by two set 
screws. 

 
9 
 
Figure 1 
The remedē® System IPG 
 
Figure 2 
The remedē® IPG Connector Ports 
1.5.2 
respistim® Stimulation Leads 
Respicardia, Inc. has developed a respistim L (left) family of leads and a respistim R (right) 
family of leads for phrenic nerve stimulation to treat CSA. The respistim family of 
stimulation leads is comprised of four unique transvenous leads designed for chronic 
stimulation and sensing when placed in a thoracic vein and connected with a compatible 
pulse generator. 
1.5.2.1 
respistim® L Stimulation Lead 
The respistim L stimulation lead (Models 2001, 2002, 2003, and 2004) is a bipolar, 
transvenous, over-the-wire lead. The proximal end of the lead contains one IS-1 terminal 
pin/connector and the distal end is comprised of two ring electrodes. The lumen of the lead is 
continuous, permitting the passage of a 0.014” guide wire for delivery into the desired target 
vein.  
1.5.2.2 
respistim® LQ Stimulation Lead 
The respistim LQ stimulation lead (Models 5045, 5055, 5065, and 5085) is a quadripolar, 
transvenous, over-the-wire lead. The proximal end of the lead has two IS-1 terminal 
pins/connectors and the distal end is comprised of four ring electrodes. The lumen of the lead 
is continuous, permitting the passage of a 0.014” guide wire for delivery into the desired 
target vein. 

 
10 
1.5.2.3 
respistim® LQS Stimulation Lead 
The respistim LQS stimulation lead (Models 4045, 4055, 4065, and 4085) is a quadripolar, 
transvenous, over-the-wire lead. The proximal end of the lead has two IS-1 terminal 
pins/connectors and the distal end is comprised of four ring electrodes having an S-shape 
bias. The lumen of the lead is continuous, permitting the passage of a 0.014” guide wire for 
delivery into the desired target vein. 
1.5.2.4 
respistim® R Stimulation Lead 
The respistim R stimulation lead (Models 3101, 3102, 3103, 3104, 3105, 3106 and 3201, 
3202, 3203, 3204, 3205, 3206) is a hexapolar, transvenous, stylet delivered lead. The 
proximal end of the lead has three IS-1 terminal pins/connectors and the distal end of the lead 
is comprised of six ring electrodes and a non-electrically active tip having a helical shape 
bias. The lead is designed for use with a stylet to remove the distal bias and permit delivery 
of the lead into the desired target vein. 
1.5.3 
Respiratory Sensing Lead 
The remedē System is designed to monitor respiration by sensing changes in transthoracic 
impedance. The system is capable of sensing respiration signals through either an implanted 
respistim stimulation lead or through a commercially available IS-1 compatible bipolar lead. 
1.5.4 
remedē® System Programmer 
The remedē System Programmer (Model 1002A, Figure 3) is a touch screen tablet computer 
used to communicate with the remedē implantable pulse generator (IPG) via inductive 
telemetry and allows for configuration of programmable settings, initiation of system testing 
and review of collected diagnostic data. Communication with the implanted device is 
achieved using the remedē programming software and an external programming wand 
(Model 1004A or 1004A-F) connected to the programmer via USB cable. 
 
 
 
 
 
 
 
Figure 3 
The remedē System Programmer 

 
11 
1.5.5 
remedē® Programming Wand 
The remedē System programming wands (Models 1004A, Figure 4 and 1004A-F) connect to 
the System Programmer via USB and provide a magnetic inductive communication link to 
the implanted device. The Model 1004A programming wand requires placement of the wand 
directly over the implanted device for telemetry communication. The optional Model 1004A-
F provides an extended flexible antenna disc that must be placed directly over the implanted 
device and is intended to allow for real-time monitoring during a polysomnogram (PSG). 
 
 
 
 
 
Figure 4 
The remedē Programming Wand (Model 1004A) 
 
1.5.6 
remedē® External IPG 
The remedē external IPG (Model 1006, Figure 5) is used for evaluation of stimulation lead 
placement during implant of the remedē System. The external IPG (eIPG) delivers the same 
stimulation pulse as the remedē IPG and provides one set of anode and cathode connection 
ports for use with a sterile cable. 
 
 
 
 
 
Figure 5 
The remedē External IPG 
1.6 
Contraindications 
The remedē System is contraindicated for the following: 
 Patients with an active infection 
 Patients known to require magnetic resonance imaging (MRI) 

 
12 
1.7 
Warnings and Precautions 
Carefully read all warnings, precautions, and instructions before use. Follow all operating, 
maintenance, and installation procedures as described in this manual. Failure to do so may 
result in patient harm.  
1.7.1 
Warnings 
1.7.1.1 
Modified Components 
The use of modified components with the remedē® System is not allowed and may result in 
damaged components, unintended operation, or increased risks to the patient. 
1.7.1.2 
Magnetic Resonance Imaging (MRI or NMRI) 
Do not use magnetic resonance imaging (MRI or NMRI) on patients who have been 
implanted with the remedē System. Energy produced by MRI equipment may result in 
permanent tissue damage or damage to the remedē System. Alternative imaging options 
should be considered. 
1.7.1.3 
Diathermy 
Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy 
(collectively referred to as diathermy) on patients implanted with the remedē System. Energy 
produced by diathermy equipment may be transferred through the implanted system and can 
cause permanent tissue damage at the location of the implanted electrodes, resulting in severe 
injury or death. 
Diathermy can also damage the remedē System, resulting in loss of therapy and requiring 
additional surgery for system explantation and replacement. Advise the patient to inform 
their health care professionals that diathermy exposure should be avoided. 
1.7.1.4 
Electric Shock 
When operating under AC power, the remedē System Programmer must be connected to a 
grounded power source to avoid risk of electric shock. 
1.7.1.5 
Concomitant Active Implantable Devices 
Use remedē System with caution in patients with an active implantable device that may be 
susceptible to unintended interaction with the remedē system. Consult Respicardia to assess 
the possibility of interaction.  
1.7.1.6 
Patients with Evidence of Phrenic Nerve Palsy 
Therapy with the remedē System may be ineffective in patients who have evidence of 
phrenic nerve palsy. 

 
13 
1.7.1.7 
Pediatric Use 
The safety and effectiveness of the remedē® System has not been established for pediatric 
use. 
1.7.1.8 
Electromagnetic Compatibility and Medical Procedure Precautions 
The remedē System is designed to ensure immunity from most common sources of 
electromagnetic interference (EMI). In most cases, turning off the EMI source, or moving 
away from the EMI source will return the IPG to normal operation. Extremely strong sources 
of EMI could interfere with normal IPG operation, causing the IPG to reset and requiring the 
programmed settings to be reconfigured. For information on MRI and diathermy, see 
‘Warnings’ in sections 1.7.1.2 and 1.7.1.3. 
1.7.1.8.1 
Electrocautery 
Electrocautery may induce failure of the IPG and leads if direct contact is made. Alternatives 
to electrocautery should be used when available. If electrocautery is necessary, the remedē 
System should be programmed off and bipolar cautery should be used. Confirm proper 
function of the remedē System after any procedure where electrocautery is used. 
1.7.1.8.2 
Radiofrequency or Cryoballoon Ablation 
If radiofrequency or cryoballoon ablation must be used in the vicinity of the IPG or leads, the 
remedē System should be programmed off. Avoid direct contact between the radiofrequency 
ablation or cryoballoon catheter and the implanted remedē System. 
1.7.1.8.3 
Therapeutic Radiation  
The IPG should not be directly irradiated by therapeutic levels of ionizing radiation (such as 
that produced by cobalt machines or linear accelerators used for treatment of certain cancers) 
because of the risk for damage to the remedē System. If such therapy is required, program 
the remedē System off, shield the device, and confirm proper function of the remedē System 
after treatment. 
1.7.1.8.4 
Computed Tomography (CT) Imaging 
If a CT scan is required, ensure that the remedē System is off and confirm proper function of 
the remedē System after the scan is complete. 
1.7.1.8.5 
Therapeutic Ultrasound 
Exposure to high ultrasonic frequencies may result in damage to the remedē System. It is not 
recommended to use high-output ultrasonic devices, such as an electrohydraulic lithotripter 
or bone growth simulator on patients implanted with the remedē System. If therapeutic 
ultrasound must be performed, program the remedē System off and keep the implanted 

 
14 
system a minimum of 2.5 cm (1 in) away from the ultrasonic field. Confirm proper function 
of the remedē® System after treatment. 
1.7.1.8.6 
External Defibrillation Energy 
The use of external defibrillation may cause damage to the remedē System. The risk of 
damage may be minimized by positioning the defibrillation patches or paddles a minimum of 
15 cm (6 in) and perpendicular to the IPG. Confirm proper function of the remedē System 
after any use of external defibrillation. 
1.7.1.8.7 
Patient Monitoring Equipment 
remedē System stimulation therapy may be detectable by patient monitoring equipment 
including automated external defibrillators. Confirm proper function of monitoring 
equipment if used while remedē stimulation therapy is active. 
1.7.1.8.8 
Transcutaneous Electrical Nerve Stimulators (TENS) 
TENS therapy should be used only if the remedē System is inactive (not providing 
stimulation therapy). If TENS therapy must be used, place the TENS electrodes as far from 
the remedē System as possible. TENS electrodes should also be spaced as close together as 
possible to reduce the generated electrical field. Confirm proper function of the remedē 
System after use of TENS therapy. 
1.7.1.8.9 
Electrical Isolation During Implant 
Do not allow the patient to have contact with grounded equipment that might produce 
electrical current leakage during implant. Electrical current leakage may induce arrhythmias 
that could result in patient death. 
1.7.1.8.10 
Lead Compatibility 
Only use IS-1 lead or lead extension terminals with the remedē System. Use of non IS-1 
compatible terminals may result in undersensing of respiratory activity, failure to deliver 
necessary therapy, or a leaking or intermittent electrical connection. 
1.7.1.8.11 
Concomitant Active Implantable Cardiac Devices 
It is recommended that testing for oversensing of remedē stimulation therapy by the 
concomitant cardiac device occur at the time of implant and prior to initiating remedē 
System therapy in patients with a concomitantly implanted cardiac device (testing protocol 
described on page 36). Programming of the remedē System and/or the concomitant device, 
when necessary, can prevent oversensing of remedē stimulation therapy. 
To avoid telemetry interference, one telemetric programming system should be utilized at a 
time if the concomitantly implanted device uses magnetic inductive telemetry. 

 
15 
 
1.7.1.9 
Pacemaker Dependence 
Use remedē® System therapy with caution in pacemaker dependent patients without a 
physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in 
a loss of pacing. 
1.7.1.10 Pregnancy  
The safety and effectiveness of the remedē System during pregnancy has not been 
established. 
1.7.2 
General Precautions 
1.7.2.1 
Expiration Date 
Do not use any remedē System product after its expiration date. 
1.7.2.2 
Storage Temperature Ranges 
It is recommended the remedē System be stored in a dry place according to the temperature 
ranges below: 
remedē® System 
Temperature Ranges 
remedē IPG 
0ºC (32ºF) and 50ºC (122ºF) 
respistim® R, L, LQ, LQS Leads 
5ºC (41ºF) and 30ºC (86ºF) 
remedē System Programmer 
-20ºC (-4ºF) and 70ºC (158ºF) 
Programming Wand  
-20ºC (-4ºF) and 70ºC (158ºF) 
eIPG 
0ºC (32ºF) and 50ºC (122ºF) 
1.7.3 
Home or Work Environment Precautions 
1.7.3.1 
High Powered Electric Fields 
Normal operation of the remedē System can be affected by magnetic, electrical and 
electromagnetic signals with sufficient strength or with characteristics similar to respiratory 
activity. Consult with Respicardia if the patient will be in an area where contact with current 
carrying conductors is possible or near high powered electromagnetic fields caused by 
equipment such as arc welding units, induction furnaces, induction stoves, resistance 
welders, radio or microwave transmitters, and linear power amplifiers. 
1.7.3.2 
Cellular Phones 
Normal operation of the remedē System may be affected by cellular phones. Maintain a 
minimum separation of 25 cm (10 in) between a cellular phone and the remedē System, even 
if the cellular phone is not on. 

 
16 
1.7.3.3 
Electronic Article Surveillance (EAS) 
Electronic article surveillance equipment such as retail theft prevention systems, as well as 
airport metal detectors, may interfere with the remedē System. Advise patients to walk 
directly through an EAS system and not remain near an EAS system longer than necessary. 
Where possible, alert security personnel of the implanted remedē System and request a 
manual search.  
1.7.3.4 
Common Radiofrequency Sources (e.g. RFID) 
Normal operation of the remedē System may be affected by common radiofrequency 
sources. Patients should minimize time around radiofrequency sources, such as RFID, when 
recognized they are nearby and operators of the remedē System external components should 
maintain a separation distance of 40cm from RFID systems. 
1.7.3.5 
Static Magnetic Fields 
Patients should avoid equipment or situations where they would be exposed to static 
magnetic fields greater than 10 gauss or 1 mT. Static magnetic fields may suspend therapy 
until next scheduled therapy session. Sources of static magnetic fields include, but are not 
limited to, stereo speakers, bingo wands, extractor wands, magnetic badges, or magnetic 
therapy products. 
1.7.3.6 
Wi-Fi 
Do not use or enable Wi-Fi on the remedē System Programmer to protect the system from 
cybersecurity risks.  
1.7.4 
remedē® System Therapy Hazards 
1.7.4.1 
Risk of Arrhythmia 
The stimulation lead should be placed in the right brachiocephalic vein or the left 
pericardiophrenic vein. Based on clinical study of leads placed in these locations, it is highly 
unlikely the heart would be electrically impacted by the levels of stimulation available in the 
remedē System (≤10 mA, 300 µs). Based on clinical experience and animal testing 
experience with displaced leads, it is unlikely that a displaced lead would cause significant 
arrhythmias.  
1.7.4.2 
Muscle Stimulation in Unipolar Configuration 
Under certain circumstances, such as high-output unipolar stimulation, therapy induced 
muscle stimulations may occur at the pocket site of the implanted device. This condition is 
mitigated by appropriate programming of the stimulation parameters by qualified medical 
personnel in conjunction with patient feedback. 

 
17 
1.7.4.3 
Component Failure 
As with any active implantable electronic system, the remedē® System might unexpectedly 
fail or stop working at any time due to random component fault, battery failure, exposure to 
extreme environmental interferences or environmental conditions. These factors may reduce 
system longevity, effectiveness and cause change in the performance characteristics. 
 
1.8 
Adverse Effects 
Possible adverse effects include, but are not limited to, the following: 
Implant Procedure-Related  
 Adverse contrast dye reaction such as allergic reaction, pulmonary edema, or 
worsening renal function 
 Adverse reaction to radiation exposure 
 Thromboembolism 
 Air embolism 
 Bleeding 
 Cardiac perforation including tamponade 
 Hematoma, seroma, local bruising or swelling  
 Hypotension 
 Local wound healing issues at device implant site including wound 
dehiscence, pocket erosion, extrusion, movement of implanted device, keloid 
formation 
 Pneumothorax 
 Hemothorax 
 Vascular damage, e.g., venous dissection, perforation 
 
Lead and System-Related  
 Adverse biocompatibility reaction to the implanted system  
 Infection 
 Lead breakage  
 Lead dislodgement  
 Lead not connected or secured appropriately in device header 
 Implantable device malfunction 
 Requirement for more energy to stimulate the nerve or ineffective stimulation 
 Venous occlusion 
 
Therapy-Related 
 Crosstalk with another implanted device  

 
18 
 Disrupted sleep 
 Muscle fatigue or discomfort in diaphragm, chest or abdomen from 
appropriate stimulation 
 Nerve dysfunction 
 Perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea 
 Inappropriate sensations 
 Worsening heart failure, respiratory status or overall health  
 
Other Procedure, System or Therapy-Related 
 Anxiety 
 Arrhythmia, including ventricular fibrillation 
 Death 
 Depression 
 Hypotension 
 Pain 
 Skin irritation or local allergic reaction 
 Thrombus or embolism, potentially leading to pulmonary embolism or stroke 
 
1.9 
Clinical Data Summary 
1.9.1 
Pivotal Trial of the remedē® System 
The remedē System was evaluated in a prospective, multicenter, randomized trial at study 
centers in the United States, Germany, and Poland for the indication of transvenous 
stimulation of the phrenic nerve for the treatment of central sleep apnea (CSA). 
1.9.2 
Patients Studied 
The study enrolled 151 central sleep apnea patients who underwent an implant procedure. Of 
the 151 implant attempts, 147 (97%) were successful. The study endpoints were evaluated 
based on intent to treat. The patient demographics for the remedē System Pivotal Trial are 
included in Table 1. 
 
 

 
19 
Table 1 
Baseline Demographics 
Baseline Measure 
Mean  
N=151 
Age (years) 
65 
Body Mass Index, kg/m2 
31 
Ejection Fraction, % 
40 
AHI, events/hour 
46 
CAI, events/hour 
28 
 
n (%) 
Male 
135 (89%) 
Race 
 
     Black or African American 
6 (4%) 
     Unknown 
1 (1%) 
     White 
144 (95%) 
 
1.9.3 
Study Design and Methods 
The remedē® System Pivotal Trial was a multicenter, prospective randomized trial 
conducted at 31 centers:  24 United States, 6 Germany, and 1 Poland. Prior to baseline 
assessments, patients were medically stable for 30 days in addition to having guideline 
recommended therapy appropriate for their clinical condition. Potential patients were 
identified by chart reviews and direct physician referrals. Pre-screening was performed via 
in-home sleep testing (polygraphy [PG]) or review of PSGs completed for clinical reasons.  
 
Following pre-screening, potentially eligible patients prospectively underwent a qualifying 
overnight, attended PSG within 40 days prior to implant. Eligibility required the following 
PSG results:  apnea-hypopnea index (AHI) ≥20 events/hour of sleep, central apneas (CAI) 
≥50% of all apneas and at least 30 central apnea events throughout the night, and an 
obstructive apnea index (OAI) ≤20% of the total AHI. Key exclusion criteria included factors 
prohibitive of system implantation, phrenic nerve palsy, Stage D heart failure, a 
cerebrovascular event within 12 months, CSA secondary to opioids, and advanced renal 
disease. 
 
All patients undergoing an implant attempt were randomized 1:1 to phrenic nerve stimulation 
(treatment) or control. The investigational system was implanted in both the treatment and 
control groups. All patients had a 1-month study visit after implantation that determined the 
schedule for subsequent follow-up at 3 month intervals. The system was activated in the 
treatment group at the 1-month visit according to a proprietary algorithm that applied a 

 
20 
stimulation pattern which enabled full diaphragmatic contraction while the patient continued 
to sleep. A full night PSG was completed 6 months following the 1 month visit in all subjects 
to assess the primary effectiveness endpoint. The system remained off in the control group 
through the 6-month effectiveness assessment, after which therapy was initiated and 
remained on.  
 
The primary effectiveness endpoint was a comparison of the proportions of patients in the 
treatment versus control groups achieving a reduction in AHI of ≥50% from baseline to 6 
months. The primary safety endpoint was freedom from serious adverse events associated 
with the implantation procedure, the system, or delivered therapy in the combined study 
groups through 12 months. A serious adverse event was defined as any adverse event that led 
to death, led to a serious deterioration in the health of the subject, resulted in a life-
threatening illness or injury, resulted in a permanent impairment of a body structure  or a 
body function, required inpatient hospitalization or prolongation of existing hospitalization, 
resulted in medical or surgical intervention to prevent permanent impairment to a body 
structure or a body function , or led to fetal distress, fetal death or a congenital abnormality 
or birth defect.  
 
1.9.4 
Study Results 
1.9.4.1 
Safety 
1.9.4.1.1 
Primary Safety Endpoint 
The percentage of subjects free from serious adverse events (SAE) associated with the 
implant procedure, the remedē® system, or the delivered therapy through the 12 month visit 
was 91% [95% exact CI (86%, 95%)]. No statistical hypothesis testing was performed on this 
endpoint (Table 2). 
Table 2 
Summary of Freedom from Related SAEs through 12 Month Visit (ITT) 
Variable 
Pooled1 
(N=151 ) 
Freedom from related SAEs 
91% (138) 
(86%, 95%) 
1 Percent (n) and 95% exact confidence interval. 
 
Thirteen subjects (9%) each reported a single implant procedure, remedē System, or 
delivered therapy related SAE. Table 3 displays the number of each type of event reported, 
along with the number and percentage of subjects who experienced the event.  
 
 

 
21 
Table 3 
Summary of Serious Adverse Events by Relation to Implant Procedure, 
remedē® System, or Delivered Therapy through 12 Months 
 
Pooled (N=151) 
 
Implant, System 
and/or Therapy 
Related1,2 
Implant 
Procedure 
Related 
System Related 
Delivered 
Therapy Related 
Event 
n 
Events 
% (n) 
Subjects 
n 
Events 
% (n) 
Subjects 
n 
Events 
% (n) 
Subjects 
n 
Events 
% (n) 
Subjects 
ANY EVENT 
13 
9% (13) 
9 
6% (9) 
6 
4% (6) 
2 
1% (2) 
IMPENDING POCKET 
EROSION 
2 
1% (2) 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
IMPLANT SITE INFECTION 
2 
1% (2) 
2 
1% (2) 
0 
0% (0) 
0 
0% (0) 
LEAD DISLODGEMENT 
2 
1% (2) 
2 
1% (2) 
2 
1% (2) 
0 
0% (0) 
CONCOMITANT DEVICE 
INTERACTION 
1 
1% (1) 
0 
0% (0) 
1 
1% (1) 
1 
1% (1) 
ELEVATED TRANSAMINASE 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
EXTRA-RESPIRATORY 
STIMULATION 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
1 
1% (1) 
IMPLANT SITE HEMATOMA 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
LEAD COMPONENT FAILURE 
1 
1% (1) 
0 
0% (0) 
1 
1% (1) 
0 
0% (0) 
LEAD DISPLACEMENT 
1 
1% (1) 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
NON-CARDIAC CHEST PAIN 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
1Relationship defined as probably or definitely related. 
2Events and subjects with events may be counted as implant procedure, system and therapy related so may not add 
up to the combined events or subjects. 
 
 

 
22 
1.9.4.1.2 
Non-Serious Related Adverse Events   
Forty-eight percent (48%) of subjects experienced a non-serious event related to the implant 
procedure, the remedē® System or delivered therapy.  Table 4 displays the number of each 
type of event reported, the number and percentage of subjects who experienced the events, 
and the relationship of the event to the implant procedure, the remedē System or delivered 
therapy.  
 

 
23 
Table 4 
Summary of Related non-Serious Adverse Events and Observations through 12 Months  
 
Pooled (N=151) 
 
Implant, System 
and/or Therapy 
Related1,2 
Implant Procedure 
Related 
System Related 
Delivered Therapy 
Related 
EVENT 
n Events 
% (n) 
Subjects 
n Events 
% (n) 
Subjects 
n Events 
% (n) 
Subjects 
n Events 
% (n) 
Subjects 
ANY EVENT 
105 
48% (73) 
30 
17% (25) 
11 
7% (11) 
67 
35% (53) 
DIAPHRAGMATIC STIMULATION 
DISCOMFORT 
48 
25% (38) 
0 
0% (0) 
1 
1% (1) 
48 
25% (38) 
EXTRA-RESPIRATORY 
STIMULATION 
15 
9% (14) 
0 
0% (0) 
0 
0% (0) 
15 
9% (14) 
IMPLANT SITE PAIN 
7 
5% (7) 
7 
5% (7) 
0 
0% (0) 
0 
0% (0) 
IMPLANT SITE HEMATOMA 
5 
3% (4) 
5 
3% (4) 
0 
0% (0) 
0 
0% (0) 
IMPLANT SITE BRUISING 
4 
3% (4) 
4 
3% (4) 
0 
0% (0) 
0 
0% (0) 
ELEVATED LEAD IMPEDANCE 
3 
2% (3) 
1 
1% (1) 
3 
2% (3) 
0 
0% (0) 
ELEVATED THRESHOLDS 
2 
1% (2) 
0 
0% (0) 
2 
1% (2) 
0 
0% (0) 
IMPLANT SITE INFLAMMATION 
2 
1% (2) 
2 
1% (2) 
0 
0% (0) 
0 
0% (0) 
INSOMNIA 
2 
1% (2) 
0 
0% (0) 
0 
0% (0) 
2 
1% (2) 
PROGRAMMING ERROR 
2 
1% (2) 
0 
0% (0) 
1 
1% (1) 
1 
1% (1) 
VENOUS THROMBOSIS 
2 
1% (2) 
0 
0% (0) 
2 
1% (2) 
0 
0% (0) 
BACK PAIN 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
CONCOMITANT DEVICE 
INTERACTION 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
1 
1% (1) 
DIARRHEA 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 

 
24 
 
Pooled (N=151) 
 
Implant, System 
and/or Therapy 
Related1,2 
Implant Procedure 
Related 
System Related 
Delivered Therapy 
Related 
EVENT 
n Events 
% (n) 
Subjects 
n Events 
% (n) 
Subjects 
n Events 
% (n) 
Subjects 
n Events 
% (n) 
Subjects 
DISSECTION OF SUBCLAVIAN 
VEIN 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
HYPOXIA 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
IMPLANT SITE ERYTHEMA 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
IMPLANT SITE INFECTION 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
IMPLANT SITE SWELLING 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
INADEQUATE LEAD POSITION 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
LEAD DISLODGEMENT 
1 
1% (1) 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
LEAD DISPLACEMENT 
1 
1% (1) 
0 
0% (0) 
1 
1% (1) 
0 
0% (0) 
SUTURE IRRITATION 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
URTICARIA 
1 
1% (1) 
1 
1% (1) 
0 
0% (0) 
0 
0% (0) 
1Relationship defined as probably or definitely related. 
2Events and subjects with events may be counted as implant procedure, system and therapy related so may not add up to the combined events or 
subjects. 
 

 
25 
1.9.4.1.3 
System Explants 
Explants of the remedē® System occurred in 5.3% (8/151) of subjects. Details are provided 
in Table 5. 
Table 5  
Summary of System Explants 
Number of 
Subjects 
Reason for System Explant  
2 
Investigational device implant site infection 
2 
Elective explant1 
1 
Device battery depletion – expected 
1 
Lead component failure2 
1 
ICD pocket infection (ICD and remedē System shared a common venous 
entry point requiring explant of both systems) 
1 
Failed stimulation lead modification procedure 
1One subject chose to exit due to an intervening medical condition (depression) and one subject withdrew 
consent and requested a system explant 
 2 Failure of one constituent part of the lead 
 
1.9.4.1.4 
Trial Withdrawals 
A total of 43 subjects had exited the trial as of the datalock. Table 6 displays the reasons for 
trial discontinuation.  
Table 6 
Summary of Reasons for Trial Withdrawals 
 
Treatment 
(N=73) 
Control 
(N=78) 
Pooled 
(N=151) 
Exit reason 
% (n) Subjects 
% (n) Subjects 
% (n) Subjects 
Physician-initiated withdrawal 
1% (1) 
3% (2) 
2% (3) 
Subject Death 
15% (11)  
14% (11) 
15% (22)  
Subject Lost to Follow-Up 
1% (1) 
1% (1) 
1% (2) 
Subject-initiated withdrawal 
8% (6)  
5% (4)  
7% (10)  
System explanted1 
7% (5) 
1% (1) 
4% (6) 
Total 
33% (24)  
24% (19)  
28% (43)  
12 subject-initiated withdrawals also underwent system explant 
 
Subjects exited for the following reasons: 
  Physician-initiated withdrawals for three (3) subjects 
o Two (2) due to intervening medical conditions 
o One (1) exit from the trial subsequent to a failed implant attempt   

 
26 
 Subject death for 22 subjects 
 Lost to follow-up for two (2) subjects  
o One (1) subject after an unsuccessful implant attempt 
o One (1) subject became unreachable despite multiple attempts by the 
investigational site to contact the subject  
Note:  Neither subject had therapy initiated at the time of being lost to follow-
up 
 Subject-initiated withdrawals for ten (10) subjects 
o Four (5) subjects withdrew due to intervening medical issues  
o Three (3) subjects withdrew due to relocating away from study site 
o Two (2) withdrew consent subsequent to failed implant attempts   
 Withdrawal due to explanted remedē® Systems occurred in six (6) subjects. Two (2) 
subject-initiated withdrawals also had the system explanted as outlined in Section 
1.9.4.1.3 
 

 
27 
1.9.4.2 
Effectiveness 
The primary effectiveness endpoint was a comparison of the proportions of patients in the 
treatment versus control groups achieving a reduction in AHI of ≥50% from baseline to 6 
months. The proportion of patients achieving ≥ 50% reduction in AHI and the 95% 
confidence interval (CI) for the Treatment group was 51% (35/68) [95% CI (39%, 64%)] 
compared to 11% (8/73) [95% CI (5%, 20%)] for the Control group, resulting in a difference 
of 41% [95% CI (25%, 54%)] (Table 7). This result was statistically significant (p<.0001), 
demonstrating that active therapy with the remedē System is superior to Control (inactive 
therapy) in achieving a 50% reduction in AHI.  
Table 7 
Summary of the Comparison of the Proportion of Patients with ≥ 50% 
Reduction in AHI at 6 Months (Modified ITT) 
Variable 
Treatment1 
Control 
Difference 
P-value2 
AHI reduced ≥ 50% 
51% (35/68) 
(39%, 64%) 
11% (8/73) 
(5%, 20%) 
41% 
(25%, 54%) 
<.0001 
Percent (n/N) and 95% Exact Confidence Interval.  
1Includes 7 patients imputed as not achieving ≥ 50% reduction in AHI. 
2 P-value from 1-sided Fisher’s Exact Test. 
1.9.4.3 
Conclusion 
The data support the reasonable assurance of safety and effectiveness of this device for 
treatment of moderate to severe CSA in adults. 
1.10 Storage and Handling 
Respicardia sterilizes the IPG and stimulation leads with ethylene oxide (EtO) prior to 
shipment.  
The materials used are biologically compatible, but they are nevertheless prone to attract 
foreign particles. Avoid any contamination before introduction of the IPG or leads into the 
body. 
Inspect the sterile package and contents prior to opening to ensure it is intact and contains a 
proper sterile use by date. The IPG, stimulation leads, and packaged accessories are intended 
for one (1) time use only and cannot be resterilized, do not implant product from a damaged 
or opened package. 
Store and transport the remedē® System in a dry place and within the recommended 
environmental temperature limits displayed in Table 8 below. 
 
 

 
28 
Table 8 
Environmental Temperature Limits 
remedē® System 
Temperature Ranges 
remedē IPG  
0ºC (32ºF) and 50ºC (122ºF) 
respistim® R, L, LQ, LQS Leads 
5ºC (41ºF) and 30ºC (86ºF) 
remedē System Programmer 
-20ºC (-4ºF) and 70ºC (158ºF) 
Programming Wand  
-20ºC (-4ºF) and 70ºC (158ºF) 
eIPG 
0ºC (32ºF) and 50ºC (122ºF) 
 
Do not implant the IPG if it has been dropped on a hard surface from a height of 30 cm (12 
in) or greater. 
Only appropriate sterile implant techniques should be used to handle the remedē System 
once removed from the sterile packaging. 
1.10.1 
Stimulation Leads 
Avoid severe bending, kinking, stretching or aggressive handling with surgical instruments 
as this may cause permanent damage to the lead. Only appropriate sterile implant techniques 
should be used to handle the stimulation lead once removed from sterile packaging. 
Published literature suggests that certain upper extremity activities can cause damage to the 
leads and possible failure of the leads. Active people, particularly those who perform 
repetitive upper extremity exercise at work or play should be cautioned that they could 
subject leads to damaging stress. 
1.11 Clinician Training 
Prior to implanting the remedē System, implanting physicians will receive instruction on 
implant tools and techniques, anatomical considerations, and instruction on concomitant 
device testing.  Clinicians will receive training related to therapy management including the 
initiation of therapy, titration, and use of the programmer.   
1.12 remedē® System Implant 
This section describes the general implant procedure of the remedē System.  Both respistim 
L (left) and respistim R (right) stimulation lead placements described in 1.11.3.2 have been 
shown to be equally effective and safe.  Similar to cardiac device transvenous lead implant 
procedures, the implanting physician will determine the appropriate stimulation lead 
placement based on visualizing the anatomy under fluoroscopy, gaining access to the vessels, 
navigating the lead to a stable location within the desired vessel, and electrically stimulating 
the nerve.  Provided the anatomy is suitable for a respistim L (left) lead placement, the 
physician should attempt to place this lead since the remedē IPG battery longevity is 
typically greater with this system configuration. 

 
29 
 
1.12.1 
Mitigation Strategies for Managing the Risk of Infection During 
remedē® System Implant, Replacement and Explant Procedures  
The following recommendations should be followed in order to minimize the risk of 
infection during the remedē System implant, replacement and explant procedures. 
 Use rigorous aseptic methods including antiseptic skin preparation 
 Administer prophylactic and post-operative antibiotics  
 Use antiseptic flush in the pocket 
 Use local antimicrobial agents 
1.12.2 
Implantable System 
 remedē System IPG 
 respistim® L, LQ, LQS, or R stimulation lead 
 IS-1 compatible bipolar transvenous lead for sensing 
1.12.3 
remedē® System Implant Procedure 
The remedē System Implant includes the following steps: 
 Locate target vessel and deploy the stimulation lead 
 Test for phrenic nerve capture and secure the stimulation lead 
 Deploy the sensing lead 
 Perform final testing  
 Create pocket, insert leads into the IPG and secure the IPG in the pocket 
 Concomitant testing (if applicable) 
1.12.3.1 Locate the Target Vessel 
 Gain venous access using the right axillary, cephalic or subclavian vein using 
standard techniques. 
 Select a puncture site near the lateral border of the first rib when utilizing a 
subclavian approach and avoid penetrating the subclavius muscle   
Caution:  Do not insert the lead under the medial one-third region of the clavicle; lead 
damage from clavicle/first rib entrapment or chronic dislodgment of the lead is possible if 
the lead is implanted in this manner. It is recommended to introduce the lead into the 
subclavian vein near the lateral border of the first rib.  
 Insert a guiding catheter and position within the left brachiocephalic vein. Refer to 
Figure 6 below for a pictorial description of typical venous anatomy. 

 
30 
 Obtain a venogram to visualize target vein ostium.  
Caution:  When locating the target vein ostium with the guiding catheter, do not force the 
catheter tip forward if resistance is felt. 
Caution:  Excessive amount and/or rate of contrast dye injection can cause extravasation 
of contrast dye or vessel dissection. 
 Cannulate the vein and visualize with selective venogram (for the left 
pericardiophrenic vein). 
 
Figure 6 
Typical Left Pericardiophrenic Vein Anatomy 
 
1.12.3.2 Deploy the Left or Right Stimulation Lead 
1.12.3.2.1 
Left Pericardiophrenic Stimulation Lead 
 Insert respistim® L, LQ, or LQS stimulation lead over a 0.014 inch guide wire 
and advance to desired position within the left pericardiophrenic vein   
 Use care when inserting a guide wire into the lead to avoid penetrating the lead 
wall or damaging the lead conductor coil. 
Note:  Flushing a clotted lead can compromise the integrity of the stimulation 
lead. If clotting is suspected, remove the lead from the body and soak in 
heparinized saline. Insert a guide wire into the proximal or distal end of the 
stimulation lead and advance to clear the lumen.  
Note: Guide wires should be handled with care at all times. A damaged guide 
wire may not behave as expected and could result in damage to the lead or 
vasculature.  

 
31 
1.12.3.2.2 
Right Brachiocephalic Stimulation Lead 
 Select the appropriate right stimulation lead model for the diameter of the 
brachiocephalic vein (See Appendix III). A lead that is too small for the vessel 
can result in weak or ineffective diaphragmatic stimulation 
 Ensure the stylet is fully advanced within the lead to the distal end of the lumen 
before inserting the right stimulation lead   
 Use care when inserting the stylet to avoid damaging the lead wall or conductor 
coil. It may be necessary to straighten the helical shape of the lead to fully 
advance the stylet 
 Place the lead through an introducer sheath and advance until the distal end of the 
lead is at the level of the superior vena cava or right atrium 
 Retract the stylet gradually and apply counterclockwise rotation to the lead body 
to allow the helical shape to form 
 Apply gentle traction and counterclockwise rotation as needed to position the 
electrodes along the lateral wall of the vessel 
 Do not allow the proximal and distal helixes to collapse and make contact as this 
will not provide a stable lead position   
 Assess the stability of the lead position by requesting that the patient  breathe 
deeply or cough during fluoroscopic observation 
Note:  Motion of the lead synchronous with cardiac systole may suggest that the lead 
is near the right atrium and should be repositioned.  
1.12.3.3 Test for Phrenic Nerve Capture  
Patient stimulation testing requires communication with the patient to ensure an appropriate 
stimulation response. Physicians should deliver procedural sedation that allows for this 
communication. See Table 9 below for recommended stimulation threshold and impedance 
values. 
 Evaluate stimulation lead impedance 
 Perform stimulation threshold testing 
o Once the stimulation lead has been placed in the desired location, make sure 
the stylet or guide wire is retracted sufficiently to expose lead bias, if 
applicable, allowing the lead to engage the vessel in a natural way. 
o Select an electrode testing configuration (cathode-anode electrode pair) and 
connect the stimulation lead to the remedē® eIPG 
Caution:  Connect the sterile cable to the remedē eIPG before connecting to the 
stimulation lead. 

 
32 
Caution:  Do not touch the exposed metal of the stimulation lead connector end 
or the exposed metal of the cable alligator clips. Do not allow the exposed metal 
of the stimulation lead connector end or the exposed metal of the cable alligator 
clips to contact electrically conductive or wet surfaces. 
Caution: Protect any unused alligator clip(s) from contact with any conductive 
surface or current leakage source. 
o Set the eIPG stimulation amplitude, pulse width and frequency based on the 
stimulation lead implanted 
 respistim® L (left) stimulation lead 
 Amplitude = 2 mA 
 Pulse Width = 150 µsec 
 Frequency = 20 Hz 
 respistim® R (right) stimulation lead 
 Amplitude = 5 mA 
 Pulse Width = 300 µsec 
 Frequency = 40 Hz 
o Deliver a single test pulse 
o Increase or decrease the stimulation current incrementally as needed until a 
moderately strong diaphragmatic contraction is observed by means of 
abdominal palpation or fluoroscopic visualization 
 If an inadequate response or no response is detected, the implanting 
physician should select a new electrode pair (for R, LQ and LQS 
leads) and repeat the stimulation threshold test before repositioning the 
stimulation lead 
 If an inadequate or no response persists, the stimulation lead should be 
repositioned and the stimulation threshold test sequence repeated until 
the desired response is achieved 
o Test for extra respiratory sensations (ERS) at levels above the stimulation 
threshold  
  ERS or sensations during stimulation other than diaphragmatic 
contraction are the result of stimulating nerves beyond the phrenic 
nerve  
 Reposition the lead if unable to avoid ERS through electrode selection 
or limitation of IPG output 
 
Table 9 
Recommended Stimulation Threshold and Impedance Values 

 
33 
Stimulation 
Lead 
Stimulation 
Threshold 
Stimulation 
Lead 
Impedance 
Criteria for stimulation threshold 
Left 
<4mA 
400 – 2000 Ω 
Clear evidence of diaphragmatic 
movement determined via palpation or 
fluoroscopy 
Right 
<5mA 
200 – 800 Ω 
 
1.12.3.4 Secure the Stimulation Lead 
 The guiding catheter (respistim® L, LQ or LQS) or introducer sheath (respistim® R) 
must be removed prior to securing the stimulation lead. For detailed instructions on 
removing the guiding catheter refer to the manufacturer’s Instructions For Use (IFU). 
 Ensure sufficient lead slack is provided within the venous system to allow for strain 
relief during changes in body position to reduce the risk of lead dislodgement. 
 Position the first ligature sleeve immediately proximal to the point of venous access 
and secure the ligature sleeve to the lead using permanent, non-absorbable sutures; 
anchor the ligature sleeve to the fascia or other suitable subcutaneous tissue using 
permanent, non-absorbable sutures. 
 For respistim R leads, place a second suture sleeve a minimum of 10 cm proximal to 
the first suture sleeve with a strain relief loop between the first and second sleeve for 
stability. 
 Maintain the guide wire or stylet within the lumen of the stimulation lead while 
securing the ligature sleeve to the lead body and anchoring to tissue in order to 
prevent damage to the stimulation lead insulation and conductor coil. 
 Do not use excessive force when tying sutures on ligature sleeves. 
 Do not kink, twist, or torque the lead while anchoring the ligature sleeve, as doing so 
could cause electrode movement. 
 Do not tie a suture directly to the lead body. 
Note:  Inadequate strain relief between proximal and distal ligature sleeves (if multiple 
ligature sleeves are present) or between ligature sleeve and IPG pocket can increase the 
risk of chronic flex damage to the lead. 
1.12.3.5 Deploy Sensing Lead 
 Deploy the sensing lead into a branch vein off the main tributary of the azygos vein 
using standard techniques 
Note:  The respistim lead or any commercially available bipolar IS-1 compatible lead can 
be utilized for sensing 
 
 

 
34 
1.12.3.6 Create Pocket, Insert Leads and Secure IPG  
Note:  For optimal performance of the 3-axis position sensor, care should be taken to ensure 
the pocket is tight forming and aligned vertically (Figure 7). 
 
 
 
 
 
 
Figure 7 
Recommended IPG Pocket Location 
The remedē IPG has four IS-1 bipolar connector ports in the header block, three for 
connecting stimulation leads and one for a sensing lead. The three stimulation lead 
ports are labeled 1-2, 3-4 and 5-6 corresponding to the following stimulation lead 
electrodes (Figure 8). The single IS-1 bipolar connector sensing lead port is labeled S 
and allows for the insertion of a bipolar sensing lead (also Figure 8): 
 
 
 
 
 
 
 
Figure 8 
The remedē® IPG Connector Block and Port Diagram 
1-2 corresponds to electrode 1 (distal) and electrode 2 
3-4 corresponds to electrode 3 and electrode 4 
5-6 corresponds to electrode 5 and electrode 6 (proximal) 
S corresponds to the sensing lead 

 
35 
Note: For easier lead insertion, insert terminal S into Sense IS-1 and lower 
stimulation port (5-6) IS-1 connectors first. 
The distal end electrodes of the respistim L Stimulation Lead correspond to the IS-1 
connections detailed in Figure 9 with electrode 1 being the most distal electrode and 
electrode 2 being the most proximal electrode. 
 
1
2
 
Figure 9 
respistim® L Stimulation Lead Connections 
The electrodes of the respistim LQ and LQS Stimulation Leads correspond to the IS-1 
connections shown in Figure 10 with electrode 1 being the most distal electrode and 
electrode 4 being the most proximal electrode. The IS-1 terminal containing the serial 
number marking corresponds to electrode 1-2. 
 
1
2
3
4
Serial #
 
Figure 10 
respistim® LQ and LQS Stimulation Lead Connections 
The electrodes of the respistim R Stimulation Leads correspond to the IS-1 connections 
shown in Figure 11 with electrode 1 being the most distal electrode and electrode 6 being the 
most proximal electrode. The IS-1 terminal containing the serial number marking 
corresponds to electrode 1-2. 
1
2
3
4
6
Serial #
5
 
Figure 11 
respistim® R Stimulation Lead Connections 

 
36 
Caution: Verify that the lead connections are secure. Loose lead connections may 
result in inappropriate sensing and/or failure to deliver stimulation therapy. 
Caution: Use only the wrench supplied with the device. The wrench is designed to 
prevent damage to the device from over tightening a setscrew. 
Caution: Counterclockwise rotation of a set screw may cause the set screw to 
disengage from the connector block. 
Caution: If a multipolar stimulation lead is not implanted, pin plugs provided with 
the device must be secured in the unused stimulation ports to avoid damage to the 
device. 
 Do not kink, twist, or braid the lead connectors with other leads, as doing so could 
cause lead insulation abrasion or conductor damage. 
 Do not bend the lead near the lead-header interface. Improper insertion can cause 
insulation or connector damage. 
 Prior to placing the IPG in the pocket, wrap any excess lead length loosely behind 
the IPG by rotating as shown in Figure 12. 
 Place the IPG and excess lead wrap in the IPG pocket with the IPG connector closest 
to the pocket incision and with the device labeling facing up toward the skin.  
 Do not coil the leads. Coiling will twist the lead bodies and may result in lead 
dislodgment. 
 
Figure 12 
Proper Rotation of IPG to Wrap Excess Lead Length 
 Test lead impedance after connecting the leads to the IPG  
 Secure the remedē® IPG in the pocket in order to minimize the risk of migration 
and mechanical interaction with the lead 
1.12.4 
Concomitant Cardiac Device Testing (if applicable) 
Testing for concomitant cardiac device interaction at the time of remedē System implant for 
patients with a pre-existing cardiac device is recommended. Concomitant device interaction 
testing should be repeated prior to therapy initiation and anytime the remedē System or the 
cardiac device system is modified. The following steps are required to complete concomitant 
device interaction testing: 

 
37 
1. Disable high voltage cardiac therapies on the cardiac device if applicable 
2. Program cardiac device sensing to the most sensitive setting and prepare for 
monitoring electrogram (EGM) and device marker channels  
3. Set up remedē® System stimulation test (2 sec duration) 
a. Acute/new remedē System: 
i. Left stimulation lead: pulse width 150μs, frequency 20 Hertz 
ii. Right stimulation lead:  pulse width 300μs, frequency 40 Hertz 
b. Chronic remedē System: 
i. Use programmed pulse width and frequency settings 
4. Deliver 2-3 stimulation pulses at 2 times the stimulation threshold 
5. Observe cardiac device EGM and marker channels for evidence of detection of 
remedē System stimulation pulses 
6. Testing should be completed with both an intrinsic (sensed) rhythm and during forced 
ventricular pacing 
1.12.5 
Postoperative Care 
Follow up according to normal postoperative care procedures. A 7 to 14 day check of the 
surgical incision healing is recommended. 
To allow for stabilization and healing after the implant procedure, the remedē System 
therapy should not be enabled for approximately 1 month following implant. 
Regular patient follow-up should be scheduled to monitor the condition of the IPG battery 
and to confirm that therapy settings are appropriately programmed. 
Intermittent or continuous loss of stimulation or sensing can be caused by a displacement of 
the electrode, unsatisfactory electrode position, breakage of the conductor or its insulation, an 
increase in thresholds, or poor electrical connection to the pulse generator. 
1.12.6 
Physician Instructions to Patient 
Information regarding the remedē System should be provided to patients including the 
warnings and precautions provided on page 13. Patients should also be instructed as follows: 
 It is normal to feel some discomfort from the surgical incision and to have some pain 
at the implant site for 2 – 6 weeks. 
 It is best to limit the mobility of the right arm (or left arm if left-sided device 
placement) and avoid lifting the arm above shoulder level for several weeks after the 
implant procedure. This time period allows the leads and IPG to affix more securely 
in place and such movements could impair the healing process. 

 
38 
 Repetitive upper extremity activities and exercise can cause damaging stress and 
possible failure to permanent implanted leads. Active patients should be cautioned to 
avoid physical activities that could damage the implant site or the implanted system. 
 Inform general practitioners and consulting physicians that the patient has an 
implanted stimulation system 
 Carry the Device/Subject Identification Card at all times 
1.12.7 
Patient Registration 
Complete a remedē® System registration form following implant of the remedē System. 
This form serves as a permanent record of facts related to the implanted system. A copy of 
this form should be returned to Respicardia. Refer to the last page of this manual for contact 
information. 
1.12.8 
Surgical Revision and Explant 
1.12.8.1 Lead Repositioning 
If the stimulation lead becomes displaced and phrenic nerve capture cannot be obtained by 
programming stimulus to other electrodes, an effort to reposition the affected lead should be 
attempted as soon as possible. Care should be taken to avoid damage to the implanted IPG, 
stimulation lead, sensing lead and surrounding tissues during the replacement procedure. If 
the displaced lead is unable to be repositioned and must be explanted, the lead should be 
returned to Respicardia for analysis and/or disposal. 
1.12.8.2 IPG Replacement 
The IPG should be replaced when IPG battery has been depleted and either the elective 
replacement indicator (ERI) or end of life (EOL) indicator is displayed on the remedē 
System Programmer. Care should be taken to avoid damage to the implanted leads during the 
replacement procedure. Confirm proper function and programming of the remedē System 
following replacement. The explanted IPG should be returned to Respicardia for analysis 
and/or disposal. 
1.12.8.3 System Explant 
The decision to remove the remedē System is the responsibility of the physician and patient 
and should be determined on a case by case basis. The risks associated with system removal 
and/or abandonment should be considered. If the IPG is removed but the leads are left in 
place, the proximal connectors of the leads should be capped to minimize tissue irritation and 
induced currents. Any explanted system components should be returned to Respicardia for 
analysis and/or disposal. 
 

 
39 
1.13 Using the remedē® System Programmer 
1.13.1 
remedē® System Programmer  
The remedē System Programmer (Figure 13) includes: 
 remedē System Programmer tablet display with remedē Programmer Software 
Application 
 remedē System Programmer wand 
 Medical grade power supply  
 
Figure 13 
remedē System Programmer Tablet Display (Model 1002A) 
1.13.1.1 remedē® System Programmer Tablet Display 
The System remedē Programmer tablet display is an interactive touch screen tablet 
controlled using the attached stylus. The external buttons and ports used by the remedē 
System are labeled along the border of the tablet display (On/Off, USB, and Power Plug). 
Other external buttons or controls on the tablet display are not used when programming the 
remedē System (see Figure 14). 

 
40 
 
Figure 14 
remedē System Programmer Tablet Display  
Connections: (1) Power input jack, (2) USB – do not use for Wi Fi connection, (3) Audio 
output jack, (4) SD memory slot with cover. 
Note: Connections 1 and 2 are required for power and remedē System connectivity. 
The power input jack may be plugged into the provided medical grade power supply. 
1.13.1.2 remedē® System Programmer Wand 
The remedē System Programmer wand (Figure 15) provides a communication link between 
the programmer tablet display and the device. The programming wand must be held over the 
device to interrogate or program. The programmer wand is connected to the programmer 
tablet display via the USB port. 
 
Figure 15 
The remedē System Programmer Wand 
1.13.1.3 Medical Grade Power Supply 
 The remedē System Programmer is powered using the provided medical grade power supply 
and power cable.  
Caution: – Use only the provided programmer power supply. Do not use the 
programmer power supply to power any other electronic devices. Never power the 

 
41 
remedē System Programmer using an extension cord, power strip or other multiple 
outlet cable. 
1.13.1.4 Connecting External Non-Respicardia Devices 
Peripheral equipment connected to the programmer tablet display must be certified according 
to applicable International Electrotechnical Commission (IEC) standards for medical 
equipment. The system, formed by connecting peripheral equipment to the programmer, must 
comply with IEC 60601-1 for medical electrical systems. It is the responsibility of the user 
connecting the peripheral equipment to comply with IEC standards. It is the responsibility of 
the user to keep peripheral equipment that is certified to IEC 60950 at least two meters away 
from the patient. Contact the peripheral equipment manufacturer for information about IEC 
certification. 
Caution: – To avoid a potential safety hazard, do not connect the remedē System 
Programmer to any non-certified outlet powered device (such as an external printer) 
during a patient session. 
1.13.1.5 External USB/CAT5 Extension  
An external USB/CAT5 extension kit may be used with the remedē System Programmer to 
allow for extended  programmer use in a sleep lab control room during a sleep study (up to 
150 ft. away from patient room). Use only an external USB/CAT5 extension kit that is 
compliant with IEC 60601-1 for medical electrical systems, compatible with USB 2.0 and 
provides power on the remote end of the extension. 
1.13.2 
Preparing for a Clinical Programming Session 
1.13.2.1 Powering On the Programmer 
The remedē System Programmer tablet display should be plugged in to an electrical outlet 
using the provided medical grade power supply. To power on the remedē System 
Programmer, press and hold the power button for at least 2 seconds until the blue LED next 
to the power button illuminates indicating power is on. 
1.13.2.2 Starting the Software Application 
When initially powered on, the remedē System Programmer will automatically launch the 
remedē System Programmer Software Application. The user may also select the Respicardia 
remedē icon (Figure 16) from the desktop to start the remedē System Programmer Software 
Application. 
 

 
42 
 
Figure 16 
The remedē® System Software Application Icon 
 
1.13.2.3 Navigating the Software Application 
 
Figure 17 
remedē System Software Application Screen 
Title Bar 
The title bar (Figure 17) is displayed at the top of the window. It identifies the software 
application currently running (Respicardia Programmer), the device serial number and 
displayed data source, which can be from an implanted device or a saved file set. 
Menu Bar  
The Menu Bar (Figure 17) is displayed under the title bar. It contains the remedē System 
Programmer commands grouped under the File, View, Log, Tools and Help pull down menu 
headings. Selecting the Menu Bar item with the touch pen will open the corresponding pull 
down menu. 
 
 
 

 
43 
Toolbar 
The toolbar (Figure 17) is displayed under the Menu Bar and offers shortcuts to frequently 
used functions from the File, Log, and Tools pull down menus from the Menu Bar. The 
toolbar also provides direct access to the mode to allow the user to quickly program between 
off, therapy and monitor modes. Selecting a button on the toolbar with the stylus will initiate 
the chosen task. See Table 10 below for remedē System Software Application toolbar icons. 
 
 
Table 10 
remedē® System Software Application Toolbar Icons 
 
New Device 
 
Read Impedance 
 
Open Saved Settings 
 
Threshold Testing 
 Print Current Settings 
 
Activate Therapy 
 
Browse Current Log 
 
Suspend Therapy 
 
Marker Detail 
 Set IPG Time 
 
Open Log File 
 
Activity & Pitch Report 
 
Add Log Bookmark 
 
Full Report 
 
Marker Mode 
 
Urgent Off 
 
Parameter Window 
The Parameter Window (Figure 17) contains all programmable parameters used to configure 
remedē System therapy. Once the remedē IPG is interrogated, the currently programmed 
settings are displayed in a tab format within the Parameter window. The parameters are 
grouped using a tab format with the following headings: Summary, Therapy, Stimulus, 
Weekly Titration, Nightly Titration, Sensors, Tools, Lab Parameters, Lab Status, and LOG 
Configuration. Selecting a tab heading will allow the user to view to the corresponding 
programmable parameters and their current values. 
 

 
44 
Programming Window 
The Programming Window (Figure 17) allows a user to interrogate the device, directly 
execute a programming command and cancel pending programming changes that have not 
been executed or undo a previous programming command. A message field is located 
beneath the programming window buttons that details parameter value conflicts, if 
applicable. 
Log Window 
The Log Window (Figure 17) contains a message field detailing history log of all interactions 
between the device and programmer during a clinical programming session. Each log entry 
will contain the following format: description, status, date and time. The date and time 
correspond to the programmer clock. If the programmer clock is different from the clock 
maintained by the implanted device, a message will appear upon initial interrogation. If 
applicable, additional log entry information may be viewed by double tapping the specific 
log entry. 
Marker Window 
The Marker Window (Figure 17) may be used to graphically view live data collected by the 
device or to review previously collected waveforms and data. Two channels may be selected 
for viewing at a time.  
Status Bar 
The Status Bar (Figure 17) indicates any current communication event (for example, 
interrogation, programming and ready). The Status Bar may also be used to indicate the 
function of any buttons as the description will be displayed when the pointer is held over a 
button. 
1.13.2.4 Positioning and Using the Programming Wand 
During a clinical programming session, telemetry communication between the remedē® 
System Programmer and the remedē IPG requires the programming wand to be positioned 
over the patient’s implanted device. The programming wand must be in place over the 
implanted device for the duration of the programming session. Lifting or moving the 
programming wand out of telemetry range will interrupt or end any tests or operations in 
progress. Replacing the wand may allow the user to resume progress saving wave or log data, 
while other functions may need to be restarted. 
The programming wand contains a number of LEDs to indicate proper position and function. 
A green power on LED indicates the programming wand is connected to the remedē System 
Programmer display and powered. A series of red, yellow, and green LEDs indicate 
telemetry signal strength with green indicating best communication, yellow indicating 

 
45 
adequate communication, and red or no LED illumination indicating poor or no 
communication. The programming wand should be repositioned in the case of red or no LED 
illumination. 
Note:  Best signal strength will be found when the distance between the Programming Wand 
and implanted device is less than 2.5 cm (1 inch). 
1.13.2.4.1 
Effect of Programming Wand on Concomitant Devices 
The remedē System Programmer Wand does not contain a strong magnet. Placing the 
Programming Wand over a concomitantly implanted device is unlikely to have an effect on 
the operation and programming of the concomitant device. 
1.13.2.5 Interrogating the remedē® IPG 
Position the Programming Wand directly over the implanted device and verify sufficient 
signal strength for proper communication. Select the interrogate button from the remedē 
System Software Application (Figure 18) using the attached stylus or by selecting Interrogate 
under the File pull down menu on the Menu Bar. The interrogate button will illuminate in 
blue if no active programming session is in progress. After successfully completing the 
interrogation, the Summary Tab and associated parameters will appear displaying current 
device status and programmed settings. 
 
Figure 18 
Interrogate Button 
 
 

 
46 
1.13.2.5.1 
Battery Status 
The measured battery voltage will be displayed with one of the following battery status 
indicator messages: 
Good 
The measured battery voltage level is above the elective replacement 
indicator level. 
ERI 
The elective replacement indicator (ERI) is triggered after 3 consecutive 
battery measurements are less than 2.60V. The remedē IPG will 
continue to operate as programmed but replacement should be 
scheduled as soon as possible. Approximately 3.3 weeks of normal 
operation remain once ERI is triggered. 
EOL 
The end of life indicator (EOL) is triggered when 3 consecutive battery 
measurements are less than 2.50V. Stimulation therapy is disabled when 
the battery reaches EOL and the remedē IPG should be replaced 
immediately. 
1.13.2.6 Urgent Off Command Using the Programming Wand 
The urgent off command is a safety feature that overrides all functions in effect and 
immediately disables stimulation therapy and programs the device to the off mode. The 
urgent off command may be initiated using the programming wand by selecting and holding 
the urgent off button for at least 2 seconds (Figure 19). An orange LED above the urgent off 
button will illuminate and flash 5 times to indicate successful programming. If not 
successful, the programming wand will automatically make one additional attempt to 
program the urgent off command. In this case the user should ensure the programming wand 
is positioned over the device with sufficient telemetry signal strength. 
 
Figure 19 
remedē® System Programmer Wand Urgent Off Button 
Once the remedē IPG has been interrogated, the user may also initiate the urgent off 
command by selecting Urgent Off from the Tools pull down menu on the Menu Bar or by 
selecting the urgent off icon from the toolbar (Figure 17). 

 
47 
Note: – The programming wand may be connected to any powered USB port to program the 
urgent off command and does not require the remedē System Software Application.  
1.13.2.7 Therapy Suspension Using a Magnet 
The remedē® System stimulation therapy can be suspended by placing a strong magnet over 
the implanted device (within 6 cm) in the event that the programming wand is unavailable. A 
magnetic sensor in the IPG can sense the presence of a strong, external magnetic field (most 
commonly generated by using a standard pacemaker donut magnet). The minimum magnetic 
field strength required to activate the magnet sensor is 25 Gauss as measured at the surface of 
the remedē System device. The magnet must be held in place for a minimum of 10 seconds 
to allow the remedē System to detect the magnetic field and confirm its presence. Once a 
magnetic field has been detected, the remedē System automatically suspends stimulation 
therapy. Once the magnetic field has been removed, stimulation therapy will resume at the 
next Scheduled Sleep Start Time (typically the next night when stimulation therapy is 
scheduled to start). 
 
 

 
48 
1.14 remedē® System Limited Warranty 
 
A. LIMITED WARRANTY. RESPICARDIA, INC. (“SELLER”) PROVIDES TO THE ORIGINAL 
PURCHASER OF THE PRODUCT (“BUYER”) THE FOLLOWING LIMITED WARRANTY FOR THE 
REMEDĒ® SYSTEM, COMPRISED OF THE IMPLANTABLE NEUROSTIMULATOR (“STIMULATOR”), 
WIRES FOR SENSING AND STIMULATION (“LEADS”), A PORTABLE HANDHELD TABLET 
(“TABLET”) 
A 
PATIENT 
WAND 
PROGRAMMING (”WAND”), 
AND 
THE 
PROPRIETARY 
REMEDĒ® SYSTEM MOBILE APP WHICH IS INSTALLED ON THE TABLET (“APP”). EACH OF THE 
STIMULATOR AND LEADS IS A “COMPONENT.” EACH OF THE TABLET AND WAND IS A “THIRD 
PARTY PRODUCT”.  
 
I. (A) EACH COMPONENT AND THIRD PARTY PRODUCT OF A SYSTEM WHEN DELIVERED TO 
BUYER WILL BE NEW, OF HIGH QUALITY, AND FREE FROM MATERIAL DEFECTS AND CONSISTENT 
WITH THE DOCUMENTATION PROVIDED; AND (B) THE APP WILL PERFORM SUBSTANTIALLY IN 
ACCORDANCE WITH THE DOCUMENTATION ACCOMPANYING THE SYSTEM. 
 
II. SHOULD THE APP FAIL TO PERFORM SUBSTANTIALLY IN ACCORDANCE WITH THE 
DOCUMENTATION WITHIN ONE YEAR, SELLER’S SOLE OBLIGATION AND BUYER’S SOLE REMEDY 
WILL BE FOR SELLER TO, AT ITS OPTION: (A) REPLACE OR REPAIR (INCLUDING AT SELLER’S 
OPTION BY REMOTE UPDATE) THE NON-CONFORMING APP OR ANY NON-CONFORMING PORTIONS 
THERETO WITH AN APP THAT CONFORMS TO THE DOCUMENTATION; OR (B) ISSUE A CREDIT TO 
BUYER. FOR CLARITY, THE APP IS LICENSED, NOT SOLD, TO BUYER, AND SELLER RETAINS ALL 
INTELLECTUAL PROPERTY RIGHTS IN AND TO THE APP. 
 
III. SHOULD ANY COMPONENT FAIL TO FUNCTION WITHIN NORMAL USE DUE TO DEFECT IN 
MATERIALS OR WORKMANSHIP WITHIN A PERIOD OF TWO (2) YEARS COMMENCING WITH THE 
DELIVERY OF THE SUCH COMPONENT TO THE BUYER, SELLER’S SOLE OBLIGATION AND 
BUYER’S SOLE REMEDY WILL BE FOR SELLER TO, AT ITS OPTION (A) REPAIR OR REPLACE THE 
APPLICABLE COMPONENT; (B) PROVIDE A FUNCTIONALLY COMPARABLE REPLACEMENT 
COMPONENT AT NO CHARGE; OR (C) ISSUE A CREDIT TO BUYER. SHOULD ANY THIRD PARTY 
PRODUCT FAIL TO FUNCTION WITHIN NORMAL USE DUE TO DEFECT IN MATERIALS OR 
WORKMANSHIP WITHIN A PERIOD OF ONE (1) YEAR COMMENCING WITH THE DELIVERY OF THE 
SUCH THIRD PARTY PRODUCT TO THE BUYER, SELLER’S SOLE OBLIGATION AND BUYER’S SOLE 
REMEDY WILL BE FOR SELLER TO, AT ITS OPTION (A) REPAIR OR REPLACE THE APPLICABLE 
THIRD PARTY PRODUCT; (B) PROVIDE A FUNCTIONALLY COMPARABLE REPLACEMENT THIRD 
PARTY PRODUCT AT NO CHARGE; OR (C) ISSUE A CREDIT TO BUYER.  
 
IV. IF SELLER CHOOSES TO ISSUE A CREDIT TO BUYER FOR A COMPONENT OR THIRD PARTY 
PRODUCT, THE CREDIT SHALL BE THE LESSER OF THE NET INVOICED PRICE OF THE ORIGINAL 
COMPONENT OR THIRD PARTY PRODUCT, OR THE CURRENT FUNCTIONALLY COMPARABLE 
COMPONENT OR THIRD PARTY PRODUCT OR REPLACEMENT COMPONENT OR THIRD PARTY 
PRODUCT. IF SELLER CHOOSES TO ISSUE A CREDIT TO BUYER FOR THE APP, THE CREDIT SHALL 

 
49 
BE EQUAL TO THE FEES PAID FOR THE TABLET. FOR COMPONENTS OR THIRD PARTY PRODUCTS 
THAT ARE USED WITH A SPECIFIC PATIENT, BUYER AGREES TO REFLECT THE CREDIT ON THE 
APPLICABLE PATIENT’S BILL AND REPORT THE CREDIT TO THE APPLICABLE PAYOR.  
 
V. IN ORDER TO QUALIFY FOR THE LIMITED WARRANTY SET FORTH HEREIN, THE 
FOLLOWING CONDITIONS MUST BE MET:  (A) THE COMPONENT OR THIRD PARTY PRODUCT MUST 
NOT HAVE BEEN REPAIRED OR ALTERED OUTSIDE OF SELLER’S FACILITY OR IN ANY WAY WHICH 
IN THE SOLE OPINION OF SELLER IMPACTS THE SYSTEM’S STABILITY AND RELIABILITY; (B) THE 
COMPONENT OR THIRD PARTY PRODUCT MUST NOT HAVE BEEN SUBJECT TO ABUSE, LACK OF 
PROPER MAINTENANCE, NEGLIGENCE, ACCIDENT, MOVEMENT, OR ADJUSTMENT OF EQUIPMENT 
BY PERSONNEL NOT AUTHORIZED BY SELLER; (C) THE COMPONENT OR THIRD PARTY PRODUCT 
MUST HAVE BEEN PUT INTO USE PRIOR TO ANY LABELED “USE BEFORE” DATE; (D) THE 
COMPONENT OR THIRD PARTY PRODUCT MUST HAVE BEEN USED IN ACCORDANCE WITH 
SELLER’S INSTRUCTIONS AND THE LABELING, AND MAY NOT HAVE BEEN USED FOR A PURPOSE 
NOT INDICATED ON THE LABELING; AND (E) NEITHER THE APP NOR ANY OTHER SOFTWARE OR 
FIRMWARE ON ANY COMPONENT OR THIRD PARTY PRODUCT MAY HAVE BEEN MODIFIED IN ANY 
WAY BY ANY PERSON OTHER THAN SELLER. FURTHERMORE, DEFECTS ARISING IN WHOLE OR 
PART AS A RESULT OF NORMAL WEAR AND USAGE, IMPROPER OR INADEQUATE MAINTENANCE, 
INTERRUPTIONS OR UNSUITABLE POWER OR COMMUNICATION SOURCES OR CONNECTIVITY, 
ENVIRONMENTAL 
CONDITIONS, 
ACCIDENT, 
MISUSE, 
ABUSE, 
IMPROPER 
INSTALLATION, 
MODIFICATION, REPAIR, STORAGE OR HANDLING, OR ANY OTHER CAUSE NOT THE FAULT OF 
SELLER ARE NOT COVERED BY THIS LIMITED WARRANTY. 
 
VI. THE LIMITED WARRANTY DOES NOT APPLY TO EXPIRATION OF COMPONENT OR THIRD 
PARTY PRODUCTS PARTS WITH A LIMITED LIFETIME, SUCH AS THE BATTERY. SELLER HEREBY 
ASSIGNS TO BUYER ANY AND ALL MANUFACTURERS’ OR SUPPLIERS’ WARRANTIES, 
GUARANTEES, REPRESENTATIONS, SERVICES AGREEMENTS AND INDEMNITIES, APPLICABLE TO 
ANY THIRD PARTY HARDWARE OR SOFTWARE DELIVERED BY BUYER IN CONNECTION WITH THE 
SYSTEM,  TO THE EXTENT ASSIGNABLE BY SELLER. 
 
B. CLAIMING THE LIMITED WARRANTY. PLEASE CONTACT SELLER’S SERVICE 
DEPARTMENT OR THE AUTHORIZED REPRESENTATIVE BY MAIL OR PHONE PRIOR TO RETURNING 
A COMPONENT OR THIRD PARTY PRODUCT FOR FURTHER INSTRUCTIONS. WHEN RETURNING A 
COMPONENT OR THIRD PARTY PRODUCT, BUYER MUST INCLUDE A COMPLETE DESCRIPTION OF 
THE ALLEGED COMPONENT OR THIRD PARTY PRODUCT FAILURE ACCOMPANIED BY A PROOF OF 
PURCHASE ATTACHED TO THE COMPONENT OR THIRD PARTY PRODUCT. IN ORDER TO QUALIFY 
FOR THE LIMITED WARRANTY SET FORTH HEREIN, BUYER MUST RETURN THE COMPONENT OR 
THIRD PARTY PRODUCT TO SELLER WITHIN THIRTY (30) DAYS AFTER DISCOVERY OF DEFECT. 
SELLER WILL BEAR THE COSTS AND RISKS OF LOSS WITH ANY RETURN TRANSPORT TO SELLER. 
BUYER WILL BEAR THE COSTS AND RISKS OF THE RETURN TRANSPORT FOR REPLACEMENT OR 
REPAIRED COMPONENTS OR THIRD PARTY PRODUCTS, PROVIDED HOWEVER, THAT BUYER 

 
50 
SHALL BE LIABLE TO SELLER FOR EXPENSES INCURRED IN CONNECTION WITH DIAGNOSING, 
REPAIRING AND/OR REPLACING ANY COMPONENT THIRD PARTY PRODUCT THAT WAS 
RETURNED OUTSIDE OF WARRANTY.  
 
C. DISCLAIMERS AND LIMITATION OF LIABILITY. THE LIMITED WARRANTY IS LIMITED TO 
ITS EXPRESS TERMS. IN PARTICULAR: 
 
 
I. EXCEPT AS EXPRESSLY PROVIDED BY THE LIMITED WARRANTY IN SECTION (A), 
SELLER MAKES NO OTHER REPRESENTATION OR WARRANTY, WITH RESPECT TO THE SYSTEM, 
ANY COMPONENT, ANY THIRD PARTY PRODUCT, OR THE APP, INCLUDING BUT NOT LIMITED TO, 
IMPLIED CONDITIONS OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, NON-
INFRINGEMENT, WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE OR ANY 
OTHER MATTER. SELLER MAKES NO REPRESENTATIONS WHATSOEVER, WHETHER EXPRESS OR 
IMPLIED, TO ANY PERSON OTHER THAN THE BUYER. NO AGENT, EMPLOYEE OR REPRESENTATIVE 
OF SELLER HAS ANY AUTHORITY TO BIND SELLER TO ANY AFFIRMATION, REPRESENTATION OR 
WARRANTY EXCEPT AS STATED IN A WRITTEN DOCUMENT SIGNED BY AN AUTHORIZED OFFICER 
OF SELLER. ALL WARNINGS CONTAINED IN THE LABELING FOR THE SYSTEM ARE AN INTEGRAL 
PART OF THIS LIMITED WARRANTY. 
 
 
II. SELLER IS NOT RESPONSIBLE FOR ANY INCIDENTAL, CONSEQUENTIAL DAMAGES 
BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE SYSTEM, ANY COMPONENT, ANY 
THIRD PARTY PRODUCT, OR THE APP, WHETHER THE CLAIM IS BASED ON WARRANTY, 
CONTRACT, TORT OR OTHERWISE. SELLER SHALL HAVE NO LIABILITY TO ANY PERSON FOR, AND 
BUYER HEREBY EXPRESSLY WAIVES, ALL REMEDIES AND DAMAGES RELATING TO INDIRECT, 
INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OF ANY DESCRIPTION, 
WHETHER ARISING OUT OF WARRANTY OR OTHER CONTRACT, NEGLIGENCE OR OTHER TORT, OR 
OTHERWISE, INCLUDING, WITHOUT LIMITATION, RESCISSION, DIFFERENCE IN VALUE DAMAGES, 
FORESEEABLE BUSINESS LOSSES, LOSS OF PROFITS AND RELIANCE DAMAGES. UNDER NO 
CIRCUMSTANCES SHALL SELLER’S LIABILITY HEREUNDER FOR ANY CAUSE EXCEED THE 
PURCHASE PRICE PAID BY BUYER FOR THE COMPONENT OR THIRD PARTY PRODUCT OUT OF 
WHICH SUCH CLAIM OR ACTION AROSE. THE PARTIES EXPRESSLY AGREE THAT THE EXCLUSIONS 
AND LIMITATIONS SET FORTH HEREIN ARE AGREED ALLOCATIONS OF RISK AND SHALL SURVIVE 
THE DETERMINATION OF ANY COURT OF COMPETENT JURISDICTION THAT ANY REMEDY 
PROVIDED HEREIN FAILS OF ITS ESSENTIAL PURPOSE. 
 
 
III. THE EXCLUSIONS, DISCLAIMERS, AND LIMITATIONS SET FORTH HEREIN ARE NOT 
INTENDED TO, AND SHALL NOT BE CONSTRUED AS TO, CONTRAVENE MANDATORY PROVISIONS 
OF ANY APPLICABLE LAW OR REGULATION. IF ANY PART OF THIS SECTION IS HELD TO BE 
ILLEGAL OR UNENFORCEABLE BY A COURT OF COMPETENT JURISDICTION, THE PART SHALL BE 
MODIFIED SO AS TO BE ENFORCEABLE TO THE MAXIMUM EXTENT POSSIBLE. IF THE PART 
CANNOT BE MODIFIED, THEN THAT PART MAY BE SEVERED AND THE OTHER PARTS OF THE 
LIMITED WARRANTY SHALL REMAIN IN FULL FORCE AND EFFECT. THIS LIMITED 

 
51 
WARRANTY IS EXPRESSED FOR THE SOLE BENEFIT OF THE ORIGINAL USER WHO PURCHASES OR 
RECEIVES THE SYSTEM, COMPONENT, APP, OR THIRD PARTY PRODUCT, AND IS NOT 
TRANSFERABLE. 
 
 

 
52 
1.15 Appendix I: remedē® System IPG Specifications 
1.15.1 
Physical Characteristics 
Table 11 
remedē System IPG (Model 1001) Physical Description 
Description 
Value 
Height 
80 mm 
Length 
47.5 mm 
Thickness 
14.6 mm 
Volume 
39 cm3 
Mass 
64 g 
Materials exposed to tissue 
Titanium, epoxy resin, silicone rubber 
1.15.2 
Lead Connectors 
The remedē Pulse Generator has been designed to accept 3.2 mm IS-1 lead connectors.  
1.15.3 
Radiopaque Identification 
A radiopaque ID marker placed inside the remedē IPG connector block allows the model 
number and year of manufacture to be identified by normal X-ray techniques. The 
identification is composed by the manufacturer’s identification code (CCI), the model code 
(E) and the last two digits of the manufacture year (Figure 20). 
 
Figure 20 
remedē System IPG Radiopaque Identifier 
 
 

 
53 
1.15.4 
Battery Information 
Table 12 
remedē® System IPG (Model 1001) Battery Information 
Chemistry 
Lithium Carbon Monofluoride (WG 9086) 
Nominal Voltage 
2.9 – 2.95 Volts (at 37ºC) 
Capacity 
2.2 Amp-hours (Ah) 
Elective Replacement Indicator (ERI) 
2.60 Volts 
End of Life (EOL) 
2.50 Volts 
 
Table 13 
remedē System IPG (Model 1001) – Battery Longevity Estimates 
Settings 
Description 
Low Energy Use 
Settings 
Normal Energy Use 
Settings 
High Energy Use 
Settings 
Stimulation 
Amplitude 
2 milliamperes (mA) 
5 mA 
10 mA 
Therapy Dose 
6 hours 
7 hours 
7 hours 
Stimulation Pulse 
Width 
60 micro seconds (µs) 
150 µs 
300 µs 
Stimulation 
Frequency 
20 hertz (Hz) 
20 hertz (Hz) 
40 hertz (Hz) 
Stimulation Lead 
Impedance 
1500 ohms (Ω) 
1000 ohms (Ω) 
500 ohms (Ω) 
Stimulation Mode 
Asynchronous 
Asynchronous 
Asynchronous 
Stimulation Duty 
Cycle 
50 % 
50 % 
50 % 
System 
Measurements 
Transthoracic  
Impedance, R-wave, 
Posture 
Transthoracic  
Impedance, R-wave, 
Posture 
Transthoracic  
Impedance, R-wave, 
Posture 
Battery Longevity 
Estimate* 
55 months 
41 months 
17 months 
*Due to the anatomical relationship between the phrenic nerve and lead electrodes, patients implanted 
with the respistim® L (left) stimulation lead typically have normal to high longevity estimates.  
Patients implanted with the respistim® R (right) stimulation lead typically have normal to low 
longevity estimates.   
 
 
 

 
54 
1.15.5 
Programmable Settings 
Table 14 
remedē® System IPG (Model 1001) Programmable Settings 
Parameter 
Factory 
Value 
Programmable 
Values 
Increme
nt 
Therapy 
 
 
 
Mode 
Off 
Off, Therapy, Monitor 
 
Algorithm Mode 
Asynchronous Asynchronous, 
Synchronous 
 
Asynchronous Respiratory 
Rate 
16 breaths per 
minute (bpm) 
10 – 30 bpm 
1 bpm 
Stay in Monitor 
Off 
On, Off 
 
Asynchronous I:E Ratio 
1.0 
0.5 – 2.0 
0.1 
Synchronous Backup 
Ventilation 
16 bpm 
10 – 30 bpm 
1 bpm 
Synchronous Backup Only 
Off 
On, Off 
 
Synchronous Stimulation 
Duration 
2.0 seconds 
(sec) 
0.5 – 30.0 
0.1 sec 
Synchronous Delay 
0.5 sec 
0.1 – 4.0 sec 
0.1 sec 
Synchronous Blanking 
Period 
0.4 sec 
0.1 – 20.0 sec 
0.1 sec 
Scheduled Sleep Start (all 
days) 
22:00 
(HH:MM) 
00:00 – 23:30 (HH:MM) 30 min 
Scheduled Sleep Stop (all 
days) 
06:00 
(HH:MM) 
00:00 – 23:30 (HH:MM) 30 min 
Maximum Dose 
8 hours (hrs) 
00:30 – 12:00 
30 min 
Lack of Respiration Period 
8.0 sec 
0.5 – 30.0 sec 
0.5 sec 
 
 
 
 
Stimulation 
 
 
 
Amplitudes (Supine, Left, 
Right, Prone) 
0.1 mA 
0.0 – 10.0 mA 
0.1 mA 
Maximum Amplitudes 
(Supine, Left, Right, Prone) 
0.1 mA 
0.1 – 10.0 mA 
0.1 mA 
Pulse Width 
150 μs 
60 – 300 μs 
30 μs 
Frequency 
20 Hz 
10, 20 40 Hz 
 
Anode (+) 
Electrode 2 
Electrode 1, 2, 3, 4, 5, 6 
 
Cathode (-) 
Electrode 1 
Electrode 1, 2, 3, 4, 6, 
Can 
 

 
55 
Table 14 
remedē® System IPG (Model 1001) Programmable Settings 
Parameter 
Factory 
Value 
Programmable 
Values 
Increme
nt 
Suspension Window 
1.0 min 
0.0 – 5.0 min 
0.5 min 
Stimulation Duration 
Adaption 
Off 
On, Off 
 
Current Amplitude 
Adaption 
Off 
On, Off 
 
Continue at Imax 
On 
On, Off 
 
Ramps 
 
 
 
Rising Duration 
30 % 
0 – 100 % 
10% 
Falling Duration 
10 % 
0 – 100 % 
10% 
Baseline Amplitude 
50 % 
0 – 90 % 
10% 
Titration 
 
 
 
Nightly Titration (all 
intervals) 
100 % 
50 – 100 % 
5 % 
Nightly Titration Time 
Absolute 
Absolute, Relative 
 
Weekly Titration 
Off 
On, Off 
 
Week 2 … Week 8 
0.0 mA 
0.0 – 0.5 mA 
0.1 mA 
Sensors 
 
 
 
Activity Threshold 
8 
0 – 16 
1 
Activity Window 
2.0 min 
0.5 – 5.0 min 
0.5 min 
Sleep Latency 
5 min 
2 – 15 min 
1 min 
BioBreak Threshold 
2 min 
1 – 15 min 
1 min 
Pitch Threshold 
50 degrees 
(deg) 
5 – 90 deg 
5 deg 
Left – Supine Threshold 
40 deg 
0 – 170 deg 
10 deg 
Left – Prone Threshold 
160 deg 
10 – 180 deg 
10 deg 
Right – Supine Threshold 
-40 deg 
0 – -170 deg 
10 deg 
Right – Prone Threshold 
-160 deg 
-10 – -180 deg 
10 deg 
Transthoracic Impedance 
Measure 
 
 
 
Enable 
On 
On, Off 
 
Configuration 
Sensing – Can Sensing – Stim, Sensing 
– Can, Stim - Can 
 
R Wave  
 
 
 
Enable 
On 
On, Off 
 

 
56 
Table 14 
remedē® System IPG (Model 1001) Programmable Settings 
Parameter 
Factory 
Value 
Programmable 
Values 
Increme
nt 
Configuration 
Can & Distal 
Proximal & Distal, Can 
& Proximal, Can & 
Distal 
 
Sensitivity 
1.0 millivolt 
(mV) 
0.5 – 5.0 mV 
0.5 mV 
Refractory 
200 
millisecond 
(ms) 
200 – 500 ms 
50 ms 
dEMG  
 
 
 
Enable 
Off 
On, Off 
 
Gain 
Low 
Low, Medium, High 
 
Configuration 
Can & Distal 
Proximal & Distal, Can 
& Proximal, Can & 
Distal 
 
 
 

 
57 
1.16 Appendix II: respistim® L, LQ, and LQS Stimulation Lead 
Specifications 
1.16.1 
Physical Characteristics 
Recommended Guiding Catheter 6 French minimum 
Electrodes   
 Material 
 
 
Platinum/Iridium 
 Electrode Surface Area 
12 millimeters2 
 Coating  
 
 
None 
 Steroid  
 
 
None  
 
 
 
Lead Diameter 
 Body  
 
 
3.6 French 
 Electrodes 
 
 
3.9 French 
 Inside Diameter 
 
0.020 inch 
 Insulation Material 
 
Polyurethane 90A 
Terminal  
 Compatibility  
 
IS-1 
 Material 
 
 
316L Stainless Steel 
Conductors 
 Type  
 
 
Co-axial design, hexafilar coil with coated wire 
 
Table 15 
respistim L, LQ, and LQS Lead Model Descriptions 
respistim  L 
Model 
 
Length (centimeters) 
2001 
 
35 
2002 
 
45 
2003 
 
55 
2004 
 
70 
 
respistim LQ 
Model 
 
Length (centimeters) 
5045 
 
45 
5055 
 
55 
5065 
 
65 
5085 
 
85 
respistim LQS 
Model 
 
Length (centimeters) 
4045 
 
45 
4055 
 
55 
4065 
 
65 
4085 
 
85 

 
58 
1.17 Appendix III: respistim® R Lead Specifications 
1.17.1 
Physical Characteristics 
Recommended Introducer  
8 French 
Electrodes   
 Material 
 
 
Platinum/Iridium 
 Electrode Surface Area 
29 millimeters2 
 Coating  
 
 
None 
 Steroid  
 
 
None  
 
 
 
Lead Diameter 
 Proximal Body 
 
4.8 French 
 Distal Body 
 
 
7.0 French 
 Inside Diameter 
 
0.020 inch 
 Insulation Material 
 
Polyurethane 90A 
Terminal  
 Compatibility  
 
IS-1 
 Material 
 
 
316L Stainless Steel 
Conductors 
 Type  
 
 
Co-axial design, hexafilar coil with coated wire 
 
Table 16 
respistim R Model Descriptions 
Model 
 
Length 
(centimeters) 
 
Distal Helical Spring 
Length (millimeters) 
 
Distal Helical Spring 
Diameter (millimeters) 
3101 
 
60 
 
25 
 
20 
3102 
 
60 
 
25 
 
24 
3103 
 
60 
 
35 
 
20 
3104 
 
60 
 
35 
 
24 
3105 
 
60 
 
45 
 
20 
3106 
 
60 
 
45 
 
24 
3201 
 
80 
 
25 
 
20 
3202 
 
80 
 
25 
 
24 
3203 
 
80 
 
35 
 
20 
3204 
 
80 
 
35 
 
24 
3205 
 
80 
 
45 
 
20 
3206 
 
80 
 
45 
 
24 
 
 

 
59 
1.18 Appendix IV: Additional Programmer and eIPG Details 
The programmer display is a commercially available tablet computer certified for use in a 
clinical environment as the remedē® System Programmer. The programmer does not contain 
any user serviceable parts. 
1.18.1 
Power Supply 
The remedē System Programmer is provided with a medical grade power supply and power 
cable that fulfills the standard IEC 60601-1:2012. The power supply is rated as follows:  100-
240 VAC, 2.0-1.0A, 50-60Hz. 
Use only the power supply and power cable provided by Respicardia. The power supply 
provides electrical isolation to the patient and operator from electrical power mains. 
1.18.2 
Routine Cleaning 
Always turn the remedē System programmer OFF prior to cleaning. 
When necessary, it is recommended that a soft cloth dampened with distilled water or 
isopropyl alcohol be used to wipe the exterior case of the programming wand. Do not use 
solvents or cleaning cloths containing chemical cleaning agents. 
1.18.3 
Cybersecurity Considerations 
Do not attempt to install software on the remedē System Programmer. Software installation 
may introduce viruses/ malware into the system and corrupt the system configuration. This 
may result in a malfunction or the inability to use the remedē System Programmer. 
The remedē System Programmer wireless network (Wi-Fi) access has been disabled to 
enhance system cybersecurity robustness. Do not remove the remedē System Programmer 
Micro SD port cover at any time.  
Do not attempt to use Wi-Fi via a USB connection on the remedē System Programmer. The 
remedē System Programmer is not intended for use with any Wi-Fi connection. 
1.18.4 
eIPG Cable 
The Respicardia eIPG is used with a sterile cable having two covered alligator clips on one 
end and two 2mm male shrouded connector pins on the opposite end. The cable should have 
a length of 2-3 meters. 
 
 

 
60 
1.19 Appendix V: remedē® System Programmer Electromagnetic 
Interference Information 
The remedē System may be subject to interference from other electrical equipment being 
operated in the near vicinity. Specifically, portable and mobile radiofrequency (RF) 
equipment can interfere with the normal operation of the programming system. This shall be 
taken into account in any situation where the equipment is not operating as expected. The 
remedē System Programmer may be interfered by other equipment, even if that equipment 
complies with CISPR emission limits. 
Table 17 
Electromagnetic Emissions Guidance Declaration 
Guidance and manufacturer’s declaration – Electromagnetic Emissions 
The remedē System Programmer is intended for use in the electromagnetic environment specified 
below.  
Emissions Test 
Compliance 
Electromagnetic Environment – Guidance 
RF emissions 
CISPR 11 
Group 1 
The remedē System programmer uses RF energy only for its 
internal function. Therefore, its RF emissions are very low and 
are not likely to cause interference in nearby electronic 
equipment.  
RF emissions 
CISPR 11 
Class B 
 
The remedē System is suitable for use in all establishments, 
including domestic establishments and those directly 
connected to the public low voltage power supply network that 
supplies buildings used for domestic purposes. 
Harmonic 
Emissions 
IEC 61000-3-2 
Class A 
Voltage 
fluctuations/flicker 
emissions 
IEC 61000-3-3 
Complies 
 
 
 

 
61 
Table 18 
Electromagnetic Immunity Guidance Declaration 
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 
The remedē® System programmer is intended for use in the electromagnetic environment specified 
below. The remedē System should not be used adjacent to or stacked with other equipment and that if 
adjacent or stacked use is necessary, the remedē System should be observed to verify normal 
operation in the configuration in which it will be used. 
Immunity Test 
IEC 60601 
Test Level 
Compliance Level 
Electromagnetic 
Environment – Guidance 
Electrostatic 
discharge (ESD) 
IEC 61000-4-2 
±6 Kilovolt contact 
±8 Kilovolt air 
±6 Kilovolt contact 
±8 Kilovolt air 
Floors should be wood, 
concrete or ceramic tile. If 
floors are covered with 
synthetic material, the relative 
humidity should be at least 
30%. 
Electrical fast 
transient/burst 
IEC 61000-4-4 
±2 Kilovolt for 
power supply lines 
±1 Kilovolt for 
input/output lines 
±2.0 Kilovolt for 
power supply lines 
±1 Kilovolt for 
input/output lines 
Mains power should be that of 
a typical hospital environment. 
Do not operate motors or other 
electrically noisy equipment on 
the same mains circuit as the 
remedē System Programmer.  
Surge 
IEC 61000-4-5 
±1 Kilovolt, 
differential mode 
±2 Kilovolt, 
common mode 
±1 Kilovolt, 
differential mode 
±2 Kilovolt, common 
mode 
Mains power quality should be 
that of a typical commercial or 
hospital environment. 
Voltage dips, short 
interruptions and 
voltage variations 
on power supply 
input lines 
IEC 61000-4-11 
‹5% UT (›95% dip in 
UT) for 0.5 cycle 
40% UT  (60% dip in 
UT) for 5 cycles 
70% UT  (30% dip in 
UT) for 25 cycles 
‹5% UT (›95% dip in 
UT) for 5 sec 
100% dip in UT for 
0.5 cycle  
60% dip in UT for 5 
cycles  
30% dip in UT for 25 
cycles  
100% dip in UT for 5 
sec 
Mains power quality should be 
that of a typical commercial or 
hospital environment.  
Note: If the user of the remedē 
System Programmer requires 
continued operation during 
power interruptions, it is 
recommended that the remedē 
System Programmer be 
powered from an 
uninterruptible power supply 
or battery. 
Power frequency 
(50/60 Hz) 
 
IEC 61000-4-8 
3 A/m 
3 A/m 
Power frequency magnetic 
fields should be at levels 
characteristic of a typical 
location in a typical 
commercial or hospital 
environment. 
NOTE: UT is the AC mains voltage prior the application of the test level. 
 

 
62 
Table 19 
Electromagnetic Immunity Guidance Declaration 
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 
The remedē System programmer is intended for use in the electromagnetic environment specified 
below.  
Immunity 
Test 
IEC 60601 Test 
Level 
Compliance Level 
Electromagnetic Environment – 
Guidance 
Conducted 
RF 
IEC 61000-
4-6 
 
3 voltage root mean 
square (Vrms) 
150 kilo hertz 
(KHz) to 80 mega 
hertz (MHz) 
 
3 V 
 
Portable and mobile RF communications 
equipment should be used no closer to 
any part of the remedē System 
Programmer including cables, than the 
recommended separation distance 
calculated from the equation applicable 
to the frequency of the transmitter. 
Recommended separation distance: 
d = 1.17 √𝑃     150 kHz to 80 MHz 
d = 1.17 √𝑃     80 MHz to 800 MHz 
d = 2.33 √𝑃     800 MHz to 2.5 GHz 
where P is the maximum output power 
rating of the transmitter in watts (W) 
according to the transmitter manufacturer 
and d is the recommended separation 
distance in meters (m). 
Field strengths from fixed RF 
transmitters, as determined by an 
electromagnetic site survey,a should be 
less than the compliance level in each 
frequency range.b 
Interference may occur in the vicinity of 
equipment marked with the following 
symbol:
 
Radiated 
RF 
IEC 61000-
4-3 
3 V/m 
80 MHz to 2.5 giga 
hertz (GHz) 
3V/m 
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. 
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption 
and reflection from structures, objects and people. 
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land 
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically 
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site 
survey should be considered. If the measured field strength in the location in which the remedē System 
Programmer is used exceeds the applicable RF compliance level above, the remedē System Programmer should 
be observed to verify normal operation. If abnormal performance is observed, additional measures may be 
necessary, such as relocating the remedē System Programmer. 
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. 
 
 
 

 
63 
Table 20 
Recommended Separation Distances Between Portable and Mobile 
RF Communications Equipment 
Recommended separation distances between portable and mobile RF communications equipment 
and the remedē® System programmer 
The remedē System programmer is intended for use in an electromagnetic environment in which 
radiated RF disturbances are controlled. The customer or user of the remedē System programmer 
can help prevent electromagnetic interference by maintaining a minimum distance between 
portable and mobile RF communications equipment (transmitters) and the remedē System 
programmer as recommended below, according to the maximum output power of the 
communications equipment. 
Rated maximum 
output power 
of transmitter W 
Separation distance according to frequency of transmitter M 
150 kHz to 80 MHz 
d = 1.17 √𝑃 
80 MHz to 800 MHz 
d = 1.17 √𝑃 
800 MHz to 2.5 GHz 
d = 2.33 √𝑃 
0.01 
0.12 
0.40 
1.47 
0.1 
0.37 
0.71 
1.97 
1 
1.17 
1.27 
2.62 
10 
3.7 
2.25 
3.50 
100 
11.7 
4.0 
4.66 
For transmitters rated at a maximum output power not listed above, the recommended separation 
distance d in meters (m) can be estimated by using the equation applicable to the frequency of the 
transmitter, where P is the maximum output power rating of the transmitter in watts (W) 
according to the transmitter manufacturer. 
NOTE 1   At 80 MHz and 800 MHz, the higher frequency range applies. 
NOTE 2   These guidelines may not apply in all situations. Electromagnetic propagation is 
affected by absorption and reflection from structures, objects and people. 
 
 
 

 
64 
1.20 Appendix VI: remedē® System Programmer Communications 
& Telemetry 
1.20.1 
Telemetry Data 
Telemetry communication through magnetic induction with the programmer provides the 
means to view and set system parameters and collect device data obtaining the following 
information: 
 All programmable parameters  
 Patient information (IPG model/serial number, Lead model/serial number, Patient ID, 
Physician contact information, implant date, patient time zone) 
 Battery voltage and condition indicator (Good, Early Replacement Indicator [ERI], 
and End of Life [EOL]) 
 Statistics that include sensing and stimulation events 
 Stimulation lead impedance as well as historical record of these values 
 
The remedē System programmer communicates with the remedē IPG using a proprietary 
telemetry communication protocol. 
Table 21 
Telemetry Transmission Characteristics 
remedē System Programmer Transmission Characteristics to Implanted Device  
ASK: “0” = tone absence, “1” = tone presence,   
Bit length = 0.305 ms 
16-20 kHz carrier 
Range: ≤ 6 cm 
Power: 0.56Wpeak, 0.27Waverage 
 
1.20.2 
Troubleshooting 
Telemetry communication through magnetic induction with the programmer may encounter 
situations that require user intervention. The following are potential communication issues 
that may occur and the action that should be taken by the user. 
 
1.20.2.1 Loss of Communication with Programmer Wand 
If a loss of communication between the Programmer Display and the Programmer Wand has 
occurred, a message indicating loss of interface connection will appear on the Programmer 
Display. 

 
65 
Action: Unplug the USB cable connecting the Programmer Wand to the 
Programmer Display and wait at least 5 seconds before reconnection. 
 Additional Information: A loss of communication may be incurred 
by unplugging the USB cable or as a safety effect in the presence of 
excessive electromagnetic interference (EMI), an excessive 
electrostatic discharge (ESD), or other high energy burst (e.g. external 
defibrillation). 
 
1.20.2.2 Loss of Marker Mode or Other Telemetry Error Messages 
If a loss of communication between the Programmer Wand and the implanted device has 
occurred, a message indicating loss of telemetry connection will appear on the Programmer 
Display. 
Action: Confirm the Programming Wand is within the secure 
communication zone and attempt telemetry operation again. 
 Additional Information: A loss of communication may incur due to 
the Programming Wand not being within the secure communication 
zone or a result of the presence of excessive electromagnetic 
interference (EMI), excessive electrostatic discharge (ESD), or other 
high energy burst (e.g. external defibrillation). 
 
1.20.2.3 Loss of Programmer Operating System Functions 
If the Programmer Display experiences a functional error as related to the PC’s Operating 
System the Windows system may report an error or cause the screen to become blue with 
reported error condition, or become non-responsive to any attempted input. 
Action:  The Programmer Display may be reset by pushing the recessed 
button on the backside of the PC tablet. Once the system returns to the 
Windows desktop, launch the remedē® System Programmer Software 
Application and proceed with the programming session. 
 Additional Information: A system error, while rare, may occur with 
the Windows Operating System of the remedē System Programmer 
Display due to any number of reasons. If the error is repeated the user 
should contact Respicardia. 
 Note: If any unforeseen problem arises that renders the programmer unable to 
perform normally, the user should contact Respicardia. 
 

 
66 
1.21 Appendix VII: Service and Disposal Information 
1.21.1 
Service 
All servicing of the remedē® System Programmer components shall be performed by 
Respicardia, Inc. personnel. For Customer service, contact the address below: 
Respicardia, Inc. 
12400 Whitewater Drive, Suite 150 
Minnetonka, MN 55343 USA 
Phone: (952) 540-4470  
Fax: (952) 540-4485 
E-mail: info@Respicardia.com 
http://www.respicardia.com 
 
1.21.2 
Disposal 
The remedē IPG and leads that have been exposed to blood and/or body fluids shall be 
considered to be a potential biohazard and disposed of according to local environmental 
regulations. The remedē System programmer, programming wand, and external IPG shall be 
considered as electronic waste and disposed of according to local environmental regulations. 

67 
Respicardia, Inc. 
12400 Whitewater Drive, Suite 150 
Minnetonka, MN 55343 USA 
Phone: (952) 540-4470  
Fax: (952) 540-4485 
E-mail: info@Respicardia.com
http://www.respicardia.com
Patents:  http://www.respicardia.com/patents 
The information in this document can be changed without previous warning. No part of this 
manual may be reproduced or transmitted in any way or by any means, either electronic or 
mechanical, for any purpose without explicit written allowance by Respicardia, Inc. 
ER1300, Revision A1