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	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a lead revision on (b)(6) 2025, the patient developed redness and swelling at the device pocket beginning in mid (b)(6).These symptoms progressed, and the patient underwent a pocket revision on (b)(6) 2025.At the follow up visit on (b)(6) 2026, persistent erythema and swelling were again noted, and therapy activation was postponed.No device malfunction was identified, and the patient's condition was reported to be improving.On 29jan2026, partial clinical information was received from the site, including a wound culture result showing few staphylococcus epidermidis, confirmation that laboratory testing had been performed (values not provided), continued improvement in pocket appearance, no additional procedures planned, and a scheduled follow up visit.Additional documentation from the site remains pending.Clinical safety reviewed the submitted information on 30jan2026.Based on available records, the adverse event represents a continuation of the same pocket complication that began in mid (b)(6) and required the pocket revision on (b)(6) 2025.Because the event resulted in a surgical intervention, it meets criteria for a serious adverse event (sae).No device malfunction has been identified.The clinical appearance and submitted photo raised suspicion for a localized infection; however, culture findings were non-confirmatory, no physician diagnosis of infection was reported, and the patient's condition has been noted to be improving.

• 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 ; 6122865999
• MDR Report Key: 24273487
• Report Number: 3009144177-2026-00023
• Device Sequence Number: 10030607
• Product Code: PSR
• UDI-Device Identifier: 00857688007391
• UDI-Public: (01)00857688007391
• Combination Product (Y/N): N
• 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): 02/05/2026

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: 09/20/2026
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/05/2026
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White