BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR

    MDR report key: 3210775 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03358
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF BACKUP VVI RESET MODE WAS CONFIRMED IN THE LABORATORY. THE CAUSE WAS FOUND TO BE DUE TO EXTERNAL DEFIBRILLATION THAT CAUSED A POWER-ON RESET. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    THE DEVICE WAS FOUND IN BACK UP VVI MODE. A DEVICE DOWNLOAD SUCCESSFULLY RESET THE DEVICE. IT WAS NOTED THAT THE DEVICE WAS EXPOSED TO EXTERNAL DEFIBRILLATION. PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS LATER EXPLANTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310642 FORTIFY ASSURA VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention