BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 4193590 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04177
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 20, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. EVAL DESCRIPTION: THE DAMAGE FOUND WAS SUSTAINED IN THE FIELD. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PROCEDURE TO REVISE THE RIGHT VENTRICULAR LEAD. DURING THE PROCEDURE, THE SURGEON FOUND AN INSULATION DEFECT AND CUT THE LEFT VENTRICULAR LEAD. THE LV LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28254 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, CRMD 1258T/86

    Patients

    Seq Age Sex Outcome Treatment
    1