BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1871877 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17640
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PATIENT'S SYSTEM INCLUDES A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), A TRANSVENOUS RIGHT VENTRICULAR (RV) PACE/SENSE LEAD, A TRANSVENOUS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, AND A TRANSVENOUS LEFT VENTRICULAR (LV) LEAD.

    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 69 YR Life Threatening| R 4542| N119| S601| 0184| 1184| 4457