BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 3891200 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03540
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 6, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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. EVAL: THE REPORTED FIELD EVENT OF OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS INDICATED THE OUTPUT CIRCUITRY OF THE DEVICE WAS DAMAGED. THE DEVICE WAS TESTED ON THE BENCH AND ON UNITY TEST SYSTEM AND FOUND ALL LOW VOLTAGE DEVICE FUNCTIONS WERE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT INDUCTION TEST WAS PERFORMED. THE DEVICE CHARGED AND DELIVERED BUT DID NOT RESCUE, THE DEVICE STARTED CHARGING UP AND TRIED TO DELIVERY BUT ABORTED THE CHARGE. IT DID THIS TWO MORE TIMES BEFORE EXTERNAL DEFIBRILLATION WAS APPLIED. THE DEVICE THEN WENT INTO BACKUP VVI. THE PHYSICIAN PERFORMED AN HVLI AND MEASURED HIGH IMPEDANCE. COMPETITOR LEAD ISSUE IS SUSPECTED. THIS DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28111 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR