BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 2083697 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-02552
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    October 12, 2009
    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 AND THE LEAD POLARITY WAS CHANGED. ON (B)(6) 2010 THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE SYSTEM WAS REPROGRAMMED.

    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 55 YR