BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4092171 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05011
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 30, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 UNDERSENSING WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF STORED ELECTROGRAMS. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO SENSE DURING DFT TESTING. THE PATIENT HAD TO BE CONVERTED VIA EXTERNAL DEFIBRILLATION. THE ICD WAS REPLACED AND NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23270 FORTIFY DR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR SP02, SP48416