BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 4140300 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05915
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 29, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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 GOOD FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOW LEAD IMPEDANCE. THE LEAD REMAINED IMPLANTED AND THE PT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32787 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE, NIK NIK ST. JUDE MEDICAL, INC. CRMD 1156T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR