BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1950731 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22457
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE LEAD REMAINS IMPLANTED AND IN SERVICE WITHOUT FURTHER COMPLICATIONS. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DURING A RECENT CLINICAL FOLLOW-UP, LOSS OF CAPTURE WAS OBSERVED WITH THIS LEFT VENTRICULAR LEAD; DISLODGMENT CONFIRMED. THE PATIENT WAS ADMITTED TO THE CATHETERIZATION LABORATORY AND REPOSITIONING THE CORONARY SINUS ELECTRODE PERFORMED WITHOUT COMPLICATIONS. NO ADVERSE PATIENT EFFECTS REPORTED.

    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 Required Intervention