BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 3943893 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13458
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC AFTER A REMOTE TRANSMISSION FOR BACKUP VVI WAS RECEIVED. THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY WHILE EXERCISING. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY AND THE DEVICE WAS RESTORED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421847 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention