BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 2905254 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00467
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 20, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED AV NODE ABLATION; DURING THE PROCEDURE, IT WAS NOTED ON FLUORO THAT THE INSULATION MAY BE ABRADED. THE LEAD EXHIBITED NORMAL ELECTRICAL FUNCTION AND REMAINED IMPLANTED. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11240 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR