BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 2083710 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-02551
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 26, 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
    KS
    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 OVERSENSING. THE LEAD POLARITY WAS CHANGED.

    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 54 YR