BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3915853 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08455
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    September 13, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE INTRAPARENCHYMAL "HEMOPROHAGE" WITH HEMOPTYSIS. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39796 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1258T/86

    Patients

    Seq Age Sex Outcome Treatment
    1