BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE DR

    MDR report key: 20720272 · Received November 19, 2024

    Report

    Report Number
    2124215-2024-72579
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559174
    PMA / PMN Number
    N970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACEMAKER EXHIBITED INTERROGATION DIFFICULTIES. THE PATIENT'S CARDIOLOGY NOTED THAT THE DEVICE WAS HAVING AN ISSUE AND WAS SCHEDULED FOR REPLACEMENT. SUBSEQUENTLY, THE PACEMAKER WAS EXPLANTED AND REPLACED WITH 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
    92427 ACCOLADE DR IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION L301 728356 00802526559174

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| R