BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 2983811 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01349
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 4, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT, THE LEAD WAS IMAGED VIA FLUOROSCOPY. THE LEAD INSULATION WAS ABRADED. THE LEAD ELECTRICAL VALUES WERE NORMAL. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88322 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1