BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONATE HF CRT-D

    MDR report key: 20810853 · Received November 29, 2024

    Report

    Report Number
    2124215-2024-75491
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589744
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A RED CALL DOCTOR ICON. A PATIENT INITIATED INTERROGATION (PII) WAS PERFORMED BUT SHOWED A YELLOW COLLECTING WAVE. THE COMMUNICATOR WAS PULLED AWAY FROM ELECTRONICS AND PATIENT INITIATED INTERROGATION (PII) WAS PERFORMED AGAIN BUT THE ISSUE REMAINED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE AND THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619859 RESONATE HF CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR NIK BOSTON SCIENTIFIC CORPORATION G547 325586 00802526589744

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male