BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3891066 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03608
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 23, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INCLUDED. THE REPORTED FILED EVENT OF BVVI WAS CONFIRMED IN THE LABORATORY. THE CAUSE OF THE RESET IS DUE TO EXTERNAL DEFIBRILLATION THAT WAS USED DURING DFT TESTING AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DFT THE DEVICE WENT INTO BVVI AS A RESULT INAPPROPRIATE SHOCKS WERE DELIVERED. PATIENT WAS DEFIBRILLATED EXTERNALLY. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28064 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD CD3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA