MAUDE Adverse Event Report: ZOLL RESPICARDIA, INC REMEDE SYSTEM; IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA

Model Number	1100
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a preexisting medtronic crt-d.Patient was implanted with a remede device on (b)(6) 2023 with no cross talk between the devices noted and therapy activation occurred on (b)(6) 23.On (b)(6) 2023 patient had an rv lead integrity alert from medtronic crt-d.Patient was admitted to the hospital for evaluation and the remede device was put into monitor mode only (no therapy being given).On (b)(6) 2023 the remede representative and medtronic representative met at the patient's room to run testing.The medtronic representative adjusted the crt-d sensing lead and it felt comfortable.The ep requested and looked over the cxr to visually evaluate the integrity of the lead for any possible issues and did not see anything concerning.The remede device remained in monitor mode where the patient was discharged on (b)(6) 2023.On (b)(6) 2024 the patient was seen by the remede representative and medtronic representative at the physician office.Device testing was done with no concomitant interaction noted at this programmed therapy.The therapy was left on.On (b)(6) 2024 the remede representative was made aware the patient was having another rv lead integrity alert taking place.The patient went to the device clinic who were confident that it was not a lead issue, so they made changes to his alerts and will be seen in the clinical again on (b)(6) 2024 to do a more extensive crt-d device programmer to program around any possible cross talk/interation between the two devices.No inappropriate icd therapy was delivered to the patient at any time due to cross talk.
Additional Manufacturer Narrative
This 3500a form is an identical copy of failed 3500a form submission, report number 3009144-2024-00003 originally submitted on 02/23/2024.The original 3500a form failed at ack3 due to the following error: manufacturing number not valid.This error has been corrected.A capa was opened to prevent reoccurrence of the failed submission.

• Brand Name: REMEDE SYSTEM
• Common Device Name: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA
• Manufacturer (Section D): ZOLL RESPICARDIA, INC; 12400 whitewater dr suite 150; minnetonka MN 55343
• Manufacturer (Section G): ZOLL RESPICARDIA, INC; 12400 whitewater dr suite 150; minnetonka MN 55343
• Manufacturer Contact: kevin bentley ; 12400 whitewater dr suite 150; minnetonka, MN 55343 ; 6122865999
• MDR Report Key: 24202904
• Report Number: 3009144177-2026-00015
• Device Sequence Number: 15905095
• Product Code: PSR
• UDI-Device Identifier: 00857688007391
• UDI-Public: (01)00857688007391
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/29/2024
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White