BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 2240456 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05375
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    OJX
    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 PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEAD EXHIBITED ELEVATED THRESHOLDS. THE LEAD WAS REPROGRAMMED WITH APPROPRIATE CAPTURE AND RESOLUTION OF DIAPHRAGMATIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1156T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1