BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 12620368 · Received October 12, 2021

    Report

    Report Number
    2124215-2021-28237
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    July 12, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PACEMAKER WAS SUCCESSFULLY EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. ANOTHER DEVICE WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE EFFECTS WERE REPORTED. THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE. GHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514889 ACCOLADE MRI EL DR IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION L331 735448 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R