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	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient complained of weight loss which in turn caused her remede system device to move and become uncomfortable within the generator pocket.On (b)(6) 2024, the patient was evaluated by physician who noted a significant recent weight loss with small area at the lateral aspect of pocket with discoloration and erythema concerning for a potential localized skin infection.Patient was put on 10 day oral antibiotic regimen.On (b)(6) 2024, the patient was evaluated by physician with no overt sign of infection on (b)(6) 2024, the patient was evaluated by physician and the discoloration appeared slightly improved.No erythema.On (b)(6) 2024, the patient contacted the physician indicated the device site was "oozing yellow fluid".The physician reviewed the device site stating the device had eroded and the pocket is now infected.Physician recommended explant of remede system.On (b)(6) 2024, the patient had the remede system explanted.The patient was treated with a wound vac and iv antibiotics.
Additional Manufacturer Narrative
This 3500a form is an identical copy of failed 3500a form submission, report number: 3009144-2024-00010 originally submitted on 11dec2024.The original 3500a form failed at ack3 due to the following error: only one pma/510(k) is allowed per report.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 ; 9525404470
• MDR Report Key: 24085349
• Report Number: 3009144177-2026-00008
• Device Sequence Number: 21276164
• Product Code: PSR
• UDI-Device Identifier: 00857688007001
• UDI-Public: 0100857688007001
• 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: 2024
• 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): 01/15/2026

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: 10/14/2023
• Device Model Number: 1001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White