MAUDE Adverse Event Report: ZOLL ZOLL REMEDE SYSTEM; PHRENIC NERVE STIMULATOR FOR SLEEP APNEA

Catalog 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	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 dr.(b)(6) and dr.(b)(6) explanted the remede ipg (b)(6) and both stimulation (remede system 4065-00220) and the sensing lead (abbott 1258t-75).The pocket was cleaned using a wound vac and then closed.
Additional Manufacturer Narrative
This 3500a form, report number is an identical copy of failed 3500a form submission, report number 3009144-2023-00002 originally submitted on 08/25/2023.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.

• Brand Name: ZOLL REMEDE SYSTEM
• Common Device Name: PHRENIC NERVE STIMULATOR FOR SLEEP APNEA
• Manufacturer (Section D): ZOLL; 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: 24262007
• Report Number: 3009144177-2026-00021
• Device Sequence Number: 13149073
• Product Code: PSR
• UDI-Device Identifier: 00857688007391
• UDI-Public: (01)00857688007391
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 1100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 02/04/2026
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White