BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 8805300 · Received July 18, 2019

    Report

    Report Number
    2124215-2019-13864
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    May 3, 2019
    Report Date
    July 18, 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
    PA, US
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598058 ACCOLADE MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 731877 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R