BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3223244 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04944
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 10, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE SENSING CABLE WAS FRACTURED AT 5.6 CM FROM THE CONNECTOR PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOSS OF CAPTURE AND HIGH IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323219 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 76 YR Required Intervention