BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 4092167 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05021
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 12, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RESET WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AND OUR AUTOMATED TESTING EQUIPMENT. ANALYSIS FOUND THE CAUSE OF THE RESET WAS A FIRMWARE ISSUE DETECTING PARITY DEFECTS WHILE IN SHIP SETTINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT THE DEVICE WAS FOUND IN BVVI. THIS DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22737 UNIFY CRT-D NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1