BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 2013879 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01300
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED AN IMPEDANCE JUMP FROM THE MID 700 OHMS RANGE IN LATE (B)(6) 2010 TO 1400-1500 OHMS BY EARLY (B)(6) 2010. CAPTURE THRESHOLD VARIED HISTORICALLY, BUT SINCE THE IMPEDANCE JUMP THRESHOLD HAS REMAINED HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1158T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR