BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 4191835 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04331
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 11, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. ANALYSIS FOUND NORMAL CHARACTERISTICS ON THE RETURNED PORTION OF THE LEAD. A COMPLETE INVESTIGATION COULD NOT BE PERFORMED SINCE THE ENTIRE LEAD WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOSS OF CAPTURE AND HIGH OUTPUT, DUE TO DISLODGEMENT. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28888 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE, NIK NIK ST. JUDE MEDICAL, CRMD 1158T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention