BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3210565 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03454
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 17, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF AN ALERT FOR POSSIBLE OUTPUT DAMAGE AND OUTPUT ANOMALY WAS CONFIRMED. THE DEVICE WAS TESTED ON THE BENCH AND ALERTS WERE SEEN DURING HIGH VOLTAGE SHOCKS BUT WERE FOUND TO BE A RESULT OF A PREVIOUSLY STORED ALERT FROM THE FIELD. NO OUTPUT ANOMALY WAS FOUND AND ALL BENCH TESTING SHOWED THE DEVICE TO BE NORMAL. THE CAUSE OF THE FIELD EVENT OF AN OUTP PUT ANOMALY REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POST-OP CHECK, POSSIBLE OUTPUT CIRCUIT DAMAGE AND LAST MAX CHARGE UNSUCCESSFUL MESSAGES WERE OBSERVED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309044 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention (B)(4)