BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 20614642 · Received November 5, 2024

    Report

    Report Number
    2124215-2024-69551
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED ATRIAL UNDERSENSING, RESULTING IN INAPPROPRIATE PACING THERAPY. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND CONFIRMED THE UNDERSENSING, WHICH WAS CAUSED BY P WAVE AMPLITUDES EXCEEDING THE FIXED SENSITIVITY AND CAUSING FUNCTIONAL UNDERSENSING. TS RECOMMENDED ADJUSTING THE SENSITIVITY. THE PATIENT IS EXPECTED TO ATTEND AN IN-CLINIC VISIT FOR REPROGRAMMING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429896 ACCOLADE MRI EL DR PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L331 677860 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female