BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 9187941 · Received October 14, 2019

    Report

    Report Number
    2124215-2019-20533
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    July 15, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MODEL L331/831109 WAS EXPLANTED DUE TO INFECTION. NO FURTHER INFORMATION WAS RECEIVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978786 ACCOLADE MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 831109 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R