BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2172916 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12042
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    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 EVALUATION OF THE LEAD WAS PERFORMED. LAB ANALYSIS OBSERVED ARCING FROM THE ANODE COIL TO THE COIL BELOW THE ANODE COIL. FURTHER ANALYSIS FOUND GREEN RESIDUE ON THE ANODE COIL AT THE ARC SITE. IT WAS DETERMINED THE GUIDE WIRE WENT BETWEEN THE ANODE COIL AND THE COIL BENEATH IT, TEARING THE GORE COATING ON THE COILS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE 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 THIS AND ANOTHER LV LEAD, 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 4592| 4543| 0157| N119| 1388T| 1861