BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM

    MDR report key: 507330 · Received January 12, 2004

    Report

    Report Number
    MW1030781
    Event Type
    Injury
    Date Received
    January 12, 2004
    Date of Event
    December 31, 2003
    Report Date
    January 12, 2004
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF GLIOBLASTOMA MULTIFORME, STATUS POST RESECTION, GLIASITE/BRACHYTHERAPY 9/2003, AND EXTERNAL BEAM RADIATION THERAPY COMPLETED. PRESENTED TO ER WITH WORSENING SEIZURES. PT HAD SEIZURE THE NIGHT BEFORE AND DURING THE NIGHT. SEIZURES WERE OF SHORT DURATION, LASTING 15-20 SECONDS. PT EXPERIENCED SEIZURE IN ER AFTER IV INSERTION WHICH LASTED 20 SECONDS. PT IMMEDIATELY RETURNED TO NORMAL STATUS. NEUROLOGY ADMITTED SUBJECT OVERNIGHT. DILANTIN DOSE WAS DECREASED TO 400 MG (200 MG BID) AND KEPPRA 500 MG BID TO ANTI-SEIZURE REGIMEN. FOLLOW-UP LABORATORY FINDINGS WITH NEUROLOGY. PT WAS DISCHARGED TO HOME THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM IOTREX BRACHYTHERAPY KXK PROXIMA THERAPEUTICS, INC. * M20526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization