BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM

    MDR report key: 510940 · Received February 9, 2004

    Report

    Report Number
    75369-2004-00001
    Event Type
    Injury
    Date Received
    February 9, 2004
    Date of Event
    December 31, 2003
    Report Date
    January 13, 2004
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    IWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE IMPLANTED IN 2003 AND EXPLANTED 22 DAYS LATER. PT EXPERIENCED SEIZURES LASTING 15-20 SECONDS FOR THREE DAYS DEEMED POSSIBLY RELATED TO DEVICE. PT RETURNED TO NORMAL. HOSPITALIZED THE THIRD DAY AND DISCHARGED 12 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM BALLOON CATHETER, MANUAL RADIONUCLIDE APPLICATOR SYSTEM IWJ PROXIMA THERAPEUTICS, INC. * M20526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization 1. DILANTIN 400 MG (200 MG BID) (2003 TO UNK),| 2. KEPPRA 500 MG BID (2003 TO UNK).