BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 4192336 · Received January 11, 2014

    Report

    Report Number
    2017865-2014-02125
    Event Type
    Malfunction
    Date Received
    January 11, 2014
    Date of Event
    May 21, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE GUIDE WIRE COULDN'T BE REMOVED FROM THE LEAD DUE TO DRIED BLOOD IN THE LEAD. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22400 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1258T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR