BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 4063875 · Received January 15, 2014

    Report

    Report Number
    2938836-2014-06434
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    January 18, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF BACKUP VVI MODE WAS CONFIRMED. THE CAUSE WAS TRACED TO AN ATTEMPTED HV CHARGING (AUTO-CAPM) ON A DEVICE USING THE QHR BATTERY WHILE TEMPERATURE WERE REDUCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT WHILE STILL IN PACKAGE, THE DEVICE WAS FOUND IN BVVI MODE, THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41063 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD2231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1