BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1894431 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21790
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    February 4, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH DRIED BLOOD AND BODY FLUID IN THE LEAD LUMEN. VISUAL INSPECTION ALSO NOTED THAT THE CONDUCTOR COILS WERE DEFORMED AT 500 MM, WHICH WAS MOST LIKELY DUE TO THE USE OF A GRABBING TOOL. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD DISLODGED AND HAD PULLED BACK INTO THE RIGHT VENTRICULAR OUTFLOW TRACT. THE LV LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE INVESTIGATION IS COMPLETE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R N118| 4525| (B)(4)| 4518| 0184