BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1951998 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23199
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REPOSITIONING PROCEDURE OF THIS LEFT VENTRICULAR (LV) LEAD TOOK PLACE DUE TO PHRENIC STIMULATION, AND LEAD DISLODGEMENT. THIS LV LEAD WAS SUCCESSFULLY REPOSITIONED, AND ALL MEASUREMENTS WERE CORRECT AND WITHIN RANGE BEFORE AND AFTER THE REPOSITIONING PROCEDURE. THERE WERE 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