MAUDE Adverse Event Report: ZOLL RESPICARDIA INC REMEDE SYSTEM; IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA

Model Number	1001
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	12/19/2023
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 3009144-2024-00004 originally submitted on 05march2024.The original 3500a form failed at ack3 due to the following error: manufactuing number not valid.This error has been corrected.A capa was opened to prevent reoccurrence of the failed submission.
Event or Problem Description
On (b)(6) 2023 patient had lead revision with a new lead implanted.On (b)(6) 2023 the patiient had a wound check which noted the incision had yellowish drainage.Oral kelfex was prescribed.Patient stated to the np at that time that he did not take the antibitocs prescrived by dr (b)(6) after his revison.On (b)(6) 2023 pateint was hospitalized for an infected device.On (b)(6) 2023 patient underwent a pocket revison for infection which was described as "the device was released from the pocket but remained connected to the leads.The device and the leads were wiped sorely and the pocket was irrigated profusely after obtaining cultures.The pocket was extended medially.The device was placed back in the pocket and was secured to the underlying tissue using single 2.0 silk suture.An absorbable antibiotic envelope was placed in the pocket subcutaneously superficial device.The incison was closed using interrupted 3.0 nylon sutures.A dressing were then applied." on (b)(6) 2024 the patient had a follow up wound check that the wound "looked good with no signs of infection" per the physician office.(b)(6) 2024: patient had another physician visit with dr.(b)(6) who indicated the site looked good with no infection.

• 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: 24164481
• Report Number: 3009144177-2026-00014
• Device Sequence Number: 9001225
• Product Code: PSR
• UDI-Device Identifier: 00857688007001
• UDI-Public: (01)00857688007001
• 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
• 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: 09/18/2021
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• 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: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White