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

Model Number	1100
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	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient developed a pocket infection following the (b)(6) 2025 implant, prompting precautionary explant of the remed system on (b)(6) 2026.No systemic signs of infection were reported, no imaging was performed, and the patient is not receiving infection related treatment, with re-implantation planned in a few months.The ipg and lqs lead will be returned for analysis, and the distal lead tip was removed and sent for culture.

• Brand Name: REMEDE SYSTEM
• Common Device Name: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA
• Manufacturer (Section D): ZOLL RESPICARDIA; 12400 whitewater dr; suite 150; minnetonka MN 55343
• Manufacturer (Section G): ZOLL RESPICARDIA; 12400 whitewater dr; suite 150; minnetonka MN 55343
• Manufacturer Contact: kevin bentley ; 12400 whitewater dr; suite 150; minnetonka, MN 55343 ; 9525404470
• MDR Report Key: 24443702
• Report Number: 3009144177-2026-00024
• Device Sequence Number: 21443484
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/25/2026

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: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White