MAUDE Adverse Event Report: ZOLL Respicardia Inc. Remede System; Implanted Phrenic Nerve Stimulator for Central Speel 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	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with history of large b-cell lymphoma was hospitalized on (b)(6) 2026 for confusion, worsening tremors, and hypervolemia.Patient was in need of mri and zoll respicardia was notified and interrogated the remedy system (b)(6) 2026.Testing revealed high impedance on 2 electrodes and providers were informed that the device is no longer considered mri conditional due to high impedance.During the course of hospitalization, cbc with differential was reported as abnormal on (b)(6) 2026 and blood cultures were obtained.Blood culture results on (b)(6) 2026 reported gram (+) cocci in pairs and chains identified as enterococcus gallinarum.Due to new finding of bacteremia and lead previously found to have high impedance and device is no longer considered mri conditional; provider made the decision to explant the remedy system.The system was explanted on (b)(6) 2026 and provider noted that inspection of the pocket showed no evidence of infection.

• Brand Name: Remede System
• Common Device Name: Implanted Phrenic Nerve Stimulator for Central Speel 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: jessica demarte ; 12400 whitewater dr; suite 150; minnetonka, MN 55343 ; +1(351)500-4934
• MDR Report Key: 50478567
• Report Number: 3009144177-2026-00027
• Device Sequence Number: 16011115
• Product Code: PSR
• UDI-Device Identifier: 00857688007391
• UDI-Public: 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: 2024
• 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): 08/27/2026

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: 05/26/2026
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2024
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 170 LB
• Patient Race: White