BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1946148 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21033
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ADDITIONAL ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN OUT-OF-SERVICE FORM THAT THIS DEVICE HAD ERODED THROUGH THE SKIN WHICH LEAD TO AN INFECTION OF THE ENTIRE IMPLANTED SYSTEM. THE DEVICE AND LEADS WERE SUCCESSFULLY EXTRACTED AND THE PATIENT WAS PLACE ON ANTIBIOTIC THERAPY. THE PATIENT WILL BE SCHEDULED FOR A SYSTEM IMPLANT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R 0144| E110| 4054| A155| 1831