BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1852728 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14601
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 23, 2009
    Report Date
    July 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOSTON SCIENTIFIC REPRESENTATIVE WAS UNAWARE OF THIS EVENT. THE DEVICE AND LEADS WERE RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), DEFIBRILLATION, CORONARY SINUS, AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL LEADS WERE EXPLANTED DUE TO A PATIENT INFECTION. NO FURTHER 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 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention 0180| N118| 4135| 4517