BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2944595 · Received February 5, 2013

    Report

    Report Number
    2124215-2013-00600
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    May 10, 2012
    Report Date
    May 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) ENDOCARDIAL LEAD EXHIBITED HIGH CAPTURE THRESHOLDS WITH LOSS OF CAPTURE. X-RAY EVALUATION REVEALED THAT THE LEAD HAD DISLODGED FROM ITS ORIGINAL POSITION, BUT REMAINED WITHIN THE TARGET VESSEL. A LEAD REVISION PROCEDURE WAS PERFORMED AND DESPITE MULTIPLE ATTEMPTS BY THE PHYSICIAN, THIS LEAD WAS UNABLE TO BE REPOSITIONED SO WAS SURGICALLY ABANDONED. THE PATIENT'S PREVIOUSLY IMPLANTED LV EPICARDIAL LEAD WAS REEVALUATED, YIELDED ACCEPTABLE MEASUREMENTS, AND SUBSEQUENTLY WAS MADE THE ACTIVE LV LEAD AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED RELATED TO THE LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48404 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 4543| 4470| H215| 4047| N119| H217| 4135| 0184