BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2050776 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03479
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 ONE DAY POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD MICRO-DISLODGED CAUSING INCREASED THRESHOLD MEASUREMENTS AND DIAPHRAGM STIMULATION IN ALL PACING CONFIGURATIONS. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE THE LV LEAD WAS REPOSITIONED INTO A DIFFERENT BRANCH WITHOUT DIAPHRAGM STIMULATION. THE LEAD REMAINS IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R 0185| N119| 4542| 4470