BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 4193602 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04192
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 17, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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. EVALUATION DESCRIPTION: THE REPORTED FIELD COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED IN THE LABORATORY. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28305 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, CRMD 1258T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR