BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1771597 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13300
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 4, 2010
    Report Date
    July 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THIS LEAD WAS RETURNED FOR ANALYSIS. WHEN TESTING IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED DRIED BODY FLUID THROUGHOUT THE LUMEN OF THE LEAD. THE CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 500 MM FROM THE TERMINAL PIN. ADDITIONALLY, THE OUTER INSULATION OF THE LEAD WAS CRUSHED AT APPROXIMATELY THE SAME SPOT. THE OUTER INSULATION WAS ALSO PUCKERED, THE INNER INSULATION WAS WORN AND THE CONDUCTOR COILS WERE DEFORMED JUST BEFORE THE AREA THAT WAS FRACTURED. ELECTRICAL TESTING CONFIRMED THAT THE CONDUCTOR COILS WERE NOT CONTINUOUS. ALL OF THE LEAD OBSERVATIONS WERE CONSISTENT WITH DAMAGE INDUCED DUE TO CLAVICULAR CRUSH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR PACING LEAD WAS EXPLANTED. IT WAS REPORTED THAT A LEAD REVISION WAS PERFORMED IN ANTICIPATION THAT THE LEAD REQUIRED REPOSITIONING AS PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS. HOWEVER, AFTER THE PROCEDURE BEGAN, A REVIEW OF THE LEAD UNDER FLOROSCOPY REVEALED THAT THE LEAD HAD DISLODGED TO THE PATIENT'S RIGHT VENTRICLE AND THERE WAS EVIDENCE OF CLAVICULAR CRUSH DAMAGE. NO OTHER ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    ANALYSIS OF THIS LEAD IS NOW COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 4543| 4469| 4517| N119| H175| 0158