BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR

    MDR report key: 3220338 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04428
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF HIGH VOLTAGE CIRCUIT DAMAGE WAS CONFIRMED IN THE LABORATORY. AUTOMATED TEST FAILURES AND LOW HV IMPEDANCE MEASUREMENTS INDICATED THAT THE OUTPUT CIRCUITRY OF THE DEVICE WAS DAMAGED. THE LOW VOLTAGE FUNCTIONALITY WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT. ALL OF THE LOW VOLTAGE TEST SPECIFICATIONS WERE NORMAL. THE CAUSE OF THE FIELD EVENT WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS RETURNED DUE TO HV CIRCUIT DAMAGE DURING A SHOCK AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320932 FORTIFY ASSURA VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4)