BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3041271 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02135
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT EXPECTED TO BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND WAS FOUND TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143775 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 0180| 4469| N141| 4549| 4543