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	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a form, report number 3009144177-2026-00022 is an identical copy of failed 3500a form submission, report number 3009144-2023-00001, originally submitted on 08/01/2023.The original 3500a form failed at ack3 due to the following error: manufacturing number not valid.This error has been corrected.A capa was opened to prevent reoccurrence of the failed submission.
Event or Problem Description
The patient developed a pocket infection after remede device ipg and lead change out (b)(6) 2023.Patient treated with oral antibiotics for roughly 6 weeks without resolution of the pocket infection.On (b)(6) 2023, zoll respicardia personnel were notified that a pocket revision would be performed on the patient.On (b)(6) 2023, the patient underwent a procedure to have a tyrx antibacterial pouch placed around the ipg after the pocket was swabbed with vancomycin.The patient was seen in the clinic on (b)(6) 2023 for therapy reactivation and wound check.Patient states the incision site is healing well.There is no tenderness, nor is the wound site itching.There is no active drainage.The patient is currently completing their prescription for 100 mg doxycycline for 10 days.

• Brand Name: REMEDE SYSTEM
• Common Device Name: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA
• Manufacturer (Section D): ZOLL RESPICARDIA, INC.; 12400 whitewater drive; suite 150; minnetonka MN 55343
• Manufacturer (Section G): ZOLL RESPICARDIA, INC.; 12400 whitewater drive; suite 150; minnetonka MN 55343
• Manufacturer Contact: kevin bentley ; 12400 whitewater drive; suite 150; minnetonka, MN 55343 ; 6122865999
• MDR Report Key: 24262087
• Report Number: 3009144177-2026-00022
• Device Sequence Number: 12764980
• 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
• 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): 02/04/2026

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: 09/21/2024
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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