BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI SR

    MDR report key: 19774635 · Received July 18, 2024

    Report

    Report Number
    2124215-2024-44552
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559204
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED LOSS OF CAPTURE (LOC) ON THE LEFT BUNDLE BRANCH (LBB) LEAD CHANNEL. THE DEVICE WAS EXPLANTED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754212 ACCOLADE MRI SR IMPLANTABLE PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L310 906488 00802526559204

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R