BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1864237 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16173
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD NOTED DRIED BLOOD IN THE LUMEN, DEFORMED CONDUCTOR COILS, MELTED AND PUCKERED INSULATION FROM EXPOSURE TO ELECTROCAUTERY, AND SILICONE SEPARATION FROM THE ANODE RING. NO FUNCTIONAL TESTING PERFORMED. ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED. IN A REVISION PROCEDURE, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED BY A NEW LEAD. 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 70 YR Required Intervention 4543| N119| 7299| 4549| 4076| H217| 4193| 6949| 4542