BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2172937 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-11717
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH INSPECTION WAS PERFORMED. THE LEAD FRACTURE WAS CONFIRMED. THE CONDUCTOR COILS WERE DEFORMED AT 290, 294, 350 AND 500 TO 505 MM FROM THE TERMINAL PIN AND WERE FRACTURED AT 503 MM FROM THE TERMINAL PIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. INSULATION DAMAGE WAS ASSUMED. AN X-RAY WAS PERFORMED, CONFIRMING THE LV LEAD TO BE FRACTURED. IT WAS THOUGHT TO BE A RESULT OF A CLAVICULAR CRUSH. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS EXTRACTED SUCCESSFULLY. A VESSEL DISSECTION OCCURRED AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS WITH TWO DIFFERENT LV LEADS AND WHILE USING A BALLOON CATHETER AND AN INNER GUIDING CATHETER. IT IS UNKNOWN WHICH PRODUCT CAUSED THE DISSECTION. THE DEVICE WAS REPROGRAMMED TO RIGHT VENTRICLE (RV) ONLY AND THE PROCEDURE WAS ABANDONED. A REVISION PROCEDURE WAS SCHEDULED TO IMPLANT AN LV LEAD AT A LATER DATE.

    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 53 YR Life Threatening| R N119| 0157| 1388T| 4592| 4543| 1861