BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2041409 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00849
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    October 25, 2010
    Report Date
    June 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS SYSTEM REMAINS IMPLANTED NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPDATED EVENT DATE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), LEFT VENTRICULAR (LV), RIGHT VENTRICULAR (RV) AND COMPETITOR RIGHT ATRIAL LEAD EXPERIENCED AN INFECTION AS THE IMPLANT SITE. THIS PATIENT WAS GIVEN ANTIBIOTICS AND DISCHARGED. THE SYSTEM REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 4543| 0181| 5592| P107