BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1873920 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17922
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE, VISUAL INSPECTION INDICATED THAT THE COMPLETE LEAD WAS RETURNED. THERE WAS DRIED BODY FLUID THROUGHOUT THE LEAD LUMEN. THE INSULATION WAS MELTED 122 AND 125 MM FROM THE TERMINAL PIN AS A RESULT OF ELECTROCAUTER DAMAGE. RESISTANCE AND PRESSURE TEST WERE USED TO TEST ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD (B)(6). IT WAS NOTED THAT THERE WAS APPROPRIATE FUNCTION OF THE SYSTEM PRIOR TO THE EXPLANT PROCEDURE. THE LEAD WAS EXPLANTED AND RETURNED.

    Description of Event or Problem · 1

    --

    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 61 YR Required Intervention H219| 4517| 0137| 4086