BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 509650 · Received February 2, 2004

    Report

    Report Number
    75369-2003-00028
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    December 23, 2003
    Report Date
    December 29, 2003
    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

    IN 12/2003 SUDDEN ONSET 30 SECONDS TO 1 MINUTE PT EXPERIENCED 'BLACK-OUT'/STARING EVENTS PRECEDED BY A FEELING OF DIZZINESS AND TOTAL BODY WARMTH WITH DIAPHORESIS. THESE EVENTS WERE SIMILAR TO THE PRE-SURGERY EVENTS THAT LEAD TO DIAGNOSIS OF GLIOBLASTOMA MULTIFORME (GBM). DILANTIN LEVEL WAS OBTAINED AND PT WAS LOADED WITH 800 MG DILANTIN 12/2003. THE NEXT DAY PT EXPERIENCED 8-9 EPISODES OF FEELING LIGHT HEADED AND DIZZY AND WARM WHERE HE FELT HE WAS GOING TO 'BLACK OUT'. ONLY 2 OF THE 9 EVENTS OF THE SAME DAY RESULTS IN ACTUAL LOC. MRI COMPLETED. PT ADMITTED FOR NEUROLOGY CONSULT, EEG, AND MEDICATION ADJUSTMENT FOR SEIZURE CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R DILATIN 300 MG Q HS.