BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 2905145 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00471
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 30, 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 Location
    IL
    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 A FLUOROSCOPY REVEALED THAT THE LEFT VENTRICULAR LEAD EXHIBITED INSULATION ABRASION. ELECTRICAL PARAMETERS WERE NORMAL. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10472 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR