BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 2240397 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05437
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 15, 2011
    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
    AL
    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 ELEVATED THRESHOLDS AT IMPLANT. THE LEAD CONFIGURATION WAS CHANGED FROM BIPOLAR TO UNIPOLAR.

    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 54 YR Required Intervention