BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1862160 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16183
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD NOTED DRIED BLOOD/BODY FLUID IN THE LEAD LUMEN, AND DEFORMED CONDUCTOR COILS 719 MM FROM THE TERMINAL PIN WHICH WAS MOST LIKELY CAUSED BY A GRABBING TOOL. THE LEAD PASSED CONDUCTOR RESISTANCE AND INSULATION PRESSURE TESTING, CONFIRMING BOTH THE CONDUCTOR AND INSULATION WERE UNCOMPROMISED. ANALYSIS CONCLUDED THE LEAD PERFORMED AS EXPECTED ELECTRICALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) EXHIBITED ELEVATED THRESHOLDS AND DECREASED IMPEDANCES. A CHEST X-RAY REVEALED THE LEAD WAS DISLODGED. IN A REVISION PROCEDURE, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED BY A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4542| N119| 4195| 0184| 1290| 4555| 4136| 4137