BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMEDE SYSTEM

    MDR report key: 23427438 · Received October 30, 2025

    Report

    Report Number
    3009144177-2025-00009
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ZOLL RESPICARDIA, INC..
    Product Code
    PSR
    UDI-DI
    00857688007391
    PMA / PMN Number
    P160039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO PHYSICIAN'S OFFICE ON (B)(6) 2025 WITH COMPLAINTS OF PAIN AT IMPLANT SITE. ANTIBIOTICS WERE PRESCRIBED DURING ON (B)(6) 2025 VISIT. DURING ON (B)(6) 2025 VISIT, IT WAS NOTED THAT PATIENT DID NOT START THE ANTIBIOTICS THAT WERE PRESCRIBED ON (B)(6) 2025 AND IT WAS NOTED THAT THE INCISION IS NOW DRAINING. THE PATIENT WAS DIRECTLY ADMITTED TO THE HOSPITAL FROM THE OFFICE. INFECTIOUS DISEASE WAS CONSULTED AND DIAGNOSED PATIENT WITH A POCKET INFECTION REQUIRING REMEDE SYSTEM EXPLANT. THE REMEDE SYSTEM WAS EXPLANTED ON (B)(6) 2025. BLOOD CULTURES WERE COLLECTED ON (B)(6) 2025 AND SHOWED NO GROWTH AT 5 DAYS. CULTURES OF THE IPG POCKET WERE COLLECTED ON (B)(6) 2025 AND WERE POSITIVE FOR MSSA. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025 AND PRESCRIBED LINEZOLID 600 MG Q 12 HOURS FOR 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618241 REMEDE SYSTEM IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA PSR ZOLL RESPICARDIA, INC.. 1100 00857688007391

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention