BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY US FGI Q

    MDR report key: 4280708 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01718
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 27, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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. EVAL DESCRIPTION: THE ANOMALY OBSERVED IN THE FIELD WAS CONFIRMED VIA REVIEWING OF THE FASTPATH SUMMARY REPORT. THE HVLIC (RV TO CAN) WAS NOT SHOWN IN THE HV LEAD IMPEDANCE TREND. ALL VECTOR OF THE HVLI WAS TESTED ON THE BENCH AND ON UTS AND WAS NORMAL AT ALL TIME. X-RAY REVEALED NO ANOMALY IN THE HEADER. IT WAS NOT ABLE TO REPLICATE THE ISSUE FROM FIELD. THE CAUSE OF THE IMPEDANCE MEASUREMENT ANOMALY WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE WOULD NOT READ ALL RV VECTORS WHEN TESTED. THIS DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25814 ASSY US FGI Q IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD CD3249-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR