BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 747208 · Received July 27, 2005

    Report

    Report Number
    MW4003983
    Event Type
    Death
    Date Received
    July 27, 2005
    Date of Event
    July 4, 2005
    Report Date
    July 20, 2005
    Manufacturer
    BOSTON SCIENTIFIC SCIMED
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A WALLSTENT ENDOPROSTHESIS, 22MM DIAMETER AND 9-10 CM IN LENGTH, WAS PLACED IN THE PT. A WEEK LATER THE PT WAS TAKEN TO ANOTHER HOSP. HE HAD SYMPTOMS OF WEAKNESS AND DEHYDRATION. IT WAS NOTICED THAT THE STENT HAD PERFORATED THE COLON. DR. PERFORMED SURGERY TO FIX THE PERFORATION. THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC WALLSTENT ENDOPROSTHESIS FGE BOSTON SCIENTIFIC SCIMED * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death