BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2172912 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10102
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION, THAT DURING A FOLLOW-UP PROCEDURE, AN X-RAY WAS PERFORMED, AND REVEALED THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THE DECISION WAS THEN MADE TO PERFORM A REVISION PROCEDURE. DURING THE REVISION PROCEDURE IT WAS NOTED THAT THE POCKET WAS BIGGER, AND THE REASON FOR THE DISLODGEMENT WAS THAT THE SUTURE STITCH WAS NOT FIXED TO THE DEVICE DURING THE IMPLANT PROCEDURE. THE LV LEAD WAS SUCCESSFULLY REPOSITIONED, AND A SUTURE STITCH WAS PERFORMED. NO 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 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention