BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1894438 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21440
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THE CONDUCTOR COILS WERE DEFORMED 300 AND 510 MM FROM THE TERMINAL PIN; MOST LIKELY DUE TO A GRABBING TOOL. ADDITIONALLY, THERE WAS A CUT IN THE POLYURETHANE AT 543, 548 MM FROM THE TERMINAL PIN, DUE TO REMOVAL OF THE SUTURE SLEEVE. ELECTRICALLY, THE LEAD WAS FOUND TO BE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THIS PATIENT HAD UNDERGONE KNEE SURGERY. DURING THE POST OPERATIVE EVALUATION, AN X-RAY WAS PERFORMED AND THE TECHNICIAN INSTRUCTED THE PATIENT TO PERFORM A LOT OF STRETCHING AND MOVEMENT. FOLLOWING THE X-RAY, DIAPHRAGMATIC STIMULATION BEGAN. THE PHYSICIAN THEN PROGRAMMED OFF THE LEFT VENTRICULAR PACING AND ATTEMPTED TO REPOSITION THE LEAD. HOWEVER, THE LEAD WAS LEAKING FLUID FROM THE SIDE AT ABOUT THE MID POINT OF THE LEAD WHEN THE LEAD WAS FLUSHED. THEREFORE, THE LEAD WAS EXPLANTED AND REPLACED. 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 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 1571| 1642T| N118| 4518| V-243