BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1771640 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-14114
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 11, 2010
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIEVEC INFORMAIOTN THAT AT THE FOLLOW UP OF THIS CARDIAC RESYNCHONIZATION THERAPY PACEMAKER (CRT-P) DECUBITIS/MIGRATION OF THE DEVICE WAS NOTED. AN INVASIVE PROCEDURE TOOK PLACE AND THE DEVICE AND LEADS WERE EXPLANTED DUE TO AN INFECTION. 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