MAUDE Adverse Event Report: ZOLL RESPICARDIA, INC. REMEDE SYSTEM; IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRA 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	05/29/2024
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 3009144-2024-00007 originally submitted on 06/07/2024.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) 2020 the patient was implanted with the remede system.On (b)(6) 2022 the patient had an ipg change out for battery eol.On (b)(6) 2024 the patient had an ipg change out for battery eol.On (b)(6) 2024 the patient had the entire remede system explanted due to a pocket infection.No other details are currently available.

• Brand Name: REMEDE SYSTEM
• Common Device Name: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRA 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 55434 ; 6122865999
• MDR Report Key: 24163906
• Report Number: 3009144177-2026-00011
• Device Sequence Number: 13078599
• 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 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): 01/23/2026

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: 12/07/2025
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 01/23/2026
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White