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	Pocket Erosion (2013)
Date of Event	01/06/2025
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 originally submitted on 29jan2025.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) 2025 patient reported that he "woke up and the sheets were drenched, didn't remember seeing anything wrong with the incision prior to that day" the patient stated he did see some redness around the pocket in (b)(6) 2024.On (b)(6) 2025 the patient was admitted to the hospital.The patient has lost weight which may have led to the erosion.Culture results are pending.No information if antibiotics were started.On (b)(6) 2025 the field team was shown a picture of the pocket.Field personnel verified the device had eroded through the skin.The plan was to explant the whole system.On (b)(6) 2025 the entire remede system was explanted without incidence.

• 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: 24022100
• Report Number: 3009144177-2026-00003
• Device Sequence Number: 13407685
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• 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: 05/31/2025
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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