BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2170187 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10206
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS CONFIRMED THE CLINICAL OBSERVATIONS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THAT THE LEAD WAS VERY DAMAGED AND RETURNED IN THREE PEICES. THE LEAD BODY WAS OBSERVED TO BE CURVED AND KINKED AND THE INSULATION WAS TORN IN SEVERAL LOCATIONS. THE DAMAGE WAS FELT TO BE ATTRIBUTED TO TWIDDLER SYNDROME AND/OR EXPLANT DAMAGE. NO FRACTURES OF THE COILS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR IF THE LEAD IS RETURNED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS TRANSVENOUS LEFT VENTRICULAR (LV) AND RIGHT ATRIAL (RA) LEAD EXHIBITED TWIDDLER'S SYNDROME. THE LEADS WERE OBSERVED TO HAVE BEEN DISLODGED AND COILED UNDER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). FLUOROSCOPIC IMAGING REVEALED THAT THE INSULATION ON THE LV LEAD HAD PEELED OFF AND PART OF THE COIL WAS EXPOSED. DURING THE EXPLANT PROCEDURE, THE LV LEAD INSULATION SEPARATED FROM THE LEAD, WHICH RESULTED IN BARE WIRE COIL IN THE VEIN. BASED ON THE INSULATION SEPARATION, PART OF THE LV LEAD HAD TO BE REMOVED FROM THE GROIN AND THE REST FROM THE INCISION IN THE CHEST. THE RA LEAD WAS EXPLANTED WITHOUT INCIDENT. A NEW LV AND RA LEAD WERE SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R N119| 4136| 0185| 4543