BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3043269 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02280
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD HAD DISLODGED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145280 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R 0138| 4136| 4269| 4543| 1860| 0125| 1821| E102| N141