BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 4192240 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04134
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD HAD HIGH OUT OF RANGE IMPEDANCE AND HIGH CAPTURE THRESHOLD. THE LEAD WAS NOT USED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32095 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, CRMD 1158T/86

    Patients

    Seq Age Sex Outcome Treatment
    1