BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 1955778 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00677
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION AND THE LEAD COULD NOT BE PROGRAMMED TO TREAT THE STIMULATION. THE PATIENT WILL BE MONITORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR