BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3041289 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01829
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY REPOSITIONED. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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) LEAD EXHIBITED LOSS OF CAPTURE (LOC) ONE DAY POST IMPLANT. THE LEAD WAS OBSERVED TO HAVE DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143659 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R N164| 4517| 0184| 4135