BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3220169 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04582
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 12, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 HV LEAD ISSUE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF PROGRAMMER PRINTOUTS. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. NO DEVICE ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, WHEN INDUCTION TESTING WAS PERFORMED WITH THE NEW DEVICE AND THE CHRONIC LEAD, THE DEVICE FAILED TO RESCUE THE PATIENT. ADDITIONAL THERAPY ATTEMPTS ABORTED. ALERTS FOR POSSIBLE HV LEAD DAMAGE, LOW HV LEAD IMPEDANCE AND OUT OF RANGE PACING LEAD IMPEDANCE WERE RECEIVED. DEVICE WAS NOT IMPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321177 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 72 YR (B)(4)