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

Model Number	1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a form, report number is an identical copy of failed 3500a form submission, report number 3009144-2023-00003 originally submitted on 12oct2023.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.
Event or Problem Description
On 9/8/2023 we were notified that this patient was being scheduled for an urgent full device extraction on (b)(6) 2023 due to a pocket infection.The patient reported sometime in (b)(6) feeling some rubbing on the device from seatbelt use that eventually lead to the development of a red area around the superior-lateral corner of the device.He did not report the issue to his medical providers for multiple weeks.By that time it was clear that a pocket infection had developed.A 3m wound vac was placed at the end of the procedure.A 3m wound vac was placed at the end of the procedure.

• 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 ; 9525404470
• MDR Report Key: 24261846
• Report Number: 3009144177-2026-00020
• Device Sequence Number: 18554042
• Product Code: PSR
• UDI-Device Identifier: 00857688007001
• UDI-Public: (01)00857688007001
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/04/2026

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 Model Number: 1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White