BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4061835 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15556
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND THE PREMATURE BATTERY DEPLETION WAS FOUND TO BE DUE TO HIGH CURRENT DRAIN. THE CAUSE OF THE HIGH CURRENT DRAIN WAS AN ANOMALOUS COMPONENT ON THE RF MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP. PREVIOUSLY THE PATIENT UNDERWENT A GENERATOR CHANGE OUT DUE TO ERI, AND LV LEAD NOTED TO EXHIBIT HIGH CAPTURE THRESHOLDS. THE DEVICE WAS REPROGRAMMED TO NOT USE THE LV LEAD. THOUGH THE DEVICE WAS REPROGRAMMED, A RAPID DECREASE IN BATTERY VOLTAGE WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539942 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention