MAUDE Adverse Event Report: ZOLL RESPICARDIA, INC 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	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a form, report number 3009144177-2026-00005 is an identical copy of failed 3500a form submission, report number 3009144-2025-00001 originally submitted on 01/09/2025.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.
Event or Problem Description
On (b)(6) 2024 the patient was implanted with a remede system for central sleep apnea at the (b)(6) by dr.(b)(6).On (b)(6) 2024 the patient therapy was successfully activated.On (b)(6) 2024 the patient came in for a scheduled appointment.At that time the patient mentioned that he felt the device implantable generator was migrating in the pocket.The implanting physician evaluated the pocket and felt there was a pocket erosion causing the need for a revision of the pocket which is scheduled for (b)(6) 2025.

• 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: 24023305
• Report Number: 3009144177-2026-00005
• Device Sequence Number: 10719716
• 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: 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): 01/09/2026

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: 02/05/2026
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/09/2026
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White