BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 1896511 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04833
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 30, 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
    VA
    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 LOSS OF CAPTURE UP TO 7.5 V WHEN INSERTED INTO THE HEADERS OF TWO IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). THE LEAD REMAINS IMPLANTED, PACING WHEN PROGRAMMED FROM RING TO COIL. THE LEAD WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR