BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 4240720 · Received November 10, 2014

    Report

    Report Number
    2938836-2014-17718
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 5, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 AN ASYMPTOMATIC PATIENT PRESENTED TO CLINIC AFTER RECEIVING A VIBRATORY ALERT. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. A SOFTWARE DOWNLOAD WAS SUCCESSFULLY PERFORMED. DEVICE WAS REPROGRAMMED TO PREVIOUSLY PROGRAMMED SETTINGS. PATIENT IS DOING WELL AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724163 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR