BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 2153602 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06448
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    March 5, 2010
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SUBSEQUENT INFORMATION WAS RECEIVED THAT STATED IT TOOK FOUR HOURS TO REMOVE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4538

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR H177| N119| H227| 0158| H217| 4076| 4538| 4542