BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1951425 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22922
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH PACING THRESHOLDS WERE NOTED ON THIS LEFT VENTRICULAR (LV) LEAD. A LEAD DISLODGEMENT WAS CONFIRMED. IT WAS NOT POSSIBLE TO EXTRACT THE LEAD THUS THE PHYSICIAN ELECTED TO DEACTIVATE THE OLD LEAD AND IMPLANTED A NEW LV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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