BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3213054 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10464
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 19, 2009
    Report Date
    June 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    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) LEAD DISLODGED ONE MONTH POST IMPLANT. THE IMPLANTING PHYSICIAN ELECTED NOT TO PURSUE AN INVASIVE REVISION PROCEDURE. IT WAS LATER REPORTED THAT THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PATIENT WITH THIS DEVICE SYSTEM WAS RECENTLY HOSPITALIZED FOR HEART FAILURE. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312858 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4470| 4542| H217| 0185