BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1871701 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18764
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    November 3, 2010
    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 (B)(4) LABORATORY, THE COMPLETE LEAD WAS RETURNED. CUTS NOTED IN THE INSULATION AND SUTURE SLEEVE. THE LEAD PASSED CONDUCTOR RESISTANCE AND HIGH POTENTIAL TESTING CONFIRMING THE CONDUCTOR WAS UNCOMPROMISED AND INTACT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED WITHIN TWO DAYS OF IMPLANT. A LEAD REVISION PROCEDURE WAS PERFORMED WERE THIS LV LEAD WAS SUCCESSFULLY REPOSITIONED. THREE WEEKS LATER, THIS LEAD DISLODGED AGAIN. ANOTHER LEAD REVISION PROCEDURE WAS PERFORMED WERE THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. OTHER THAN THE PROCEDURES, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R