MAUDE Adverse Event Report: ZOLL RESPICARDIA 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	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted at (b)(6) with the remede system on (b)(6) 2025.Patient was scheduled to have therapy activated in (b)(6) 2026 but appointment was canceled due to snowstorm.Patient was rescheduled for (b)(6) 2026 but patient was hospitalized at uvm due to a fall.Patient's provider contacted zoll respicardia representative on (b)(6) 2026 to inform that hospitalist at uvm had contacted her to advise that patient developed urinary retention and mri was needed to rule out spinal cord compression.Provider requested that zoll respicardia representative go to uvm to check the remede system device.On (b)(6) 2026, hospitalist at (b)(6) contacted zoll respicardia representative directly to inform that the patient was positive for bacteremia and cultures are positive for mrsa.Email communications between hosptialist and provider notes an ulcer (cranial left, caudal right) that appeared to be healing well and surrounding pocket looks ok but with 2/2 blood cultures testing positive for mrsa, there is concern that the device is a potential source and having id team assess as well and treating with vancomycin in the meantime.Ultrasound showed features concerning for abscess under the ulcer in a pocket adjacent and connected to but distinct from just the peri-pacer region.Hospitalist informed provider that their surgery team wanted to consult with either provider or implanter regarding complexity of removal of remede system as patient declined transfer to implanting site.The remede system device was explanted at (b)(6) on (b)(6) 2026.

• Brand Name: REMEDE SYSTEM
• Common Device Name: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA
• Manufacturer (Section D): ZOLL RESPICARDIA; 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: 24793575
• Report Number: 3009144177-2026-00025
• Device Sequence Number: 13193590
• 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: 2025
• Device Explanted Year: 2026
• 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): 04/06/2026

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 Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White