BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 529412 · Received June 9, 2004

    Report

    Report Number
    1037103-2004-00010
    Event Type
    Injury
    Date Received
    June 9, 2004
    Date of Event
    May 7, 2004
    Report Date
    May 7, 2004
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE IMPLANTED IN PT IN 2004. BRACHYTHERAPY PERFORMED 01/23/2004 - 01/29/2004. PT CAME TO OFFICE 04/2004 FOR SCHEDULED VISIT AND REPORTED ANINCREASE IN STERIOD DOSAGE. IN 04/2004 MRI REVEALED INCREASED SIGNAL ABNORMALITY AND ENHANCEMENT SURROUNDING POSTERIOR RIGHT TEMPORAL LOBE RESECTION CAVITY WITH AN ASSOCIATED OTHER AREA OVER STRICTIVE DIFFUSION MEDIALLY. SPECTROSCOPY AND MR PERFUSION STUDY OBTAINED THE NEXT DAY REVEALED THIS WAS MOST LIKELY RADIATION NECROSIS, BUT ALSO SUSPECTED TO BE TUMOR RECURRENCE. MASS RESECTION PLANNED FOR THE NEXT NINE DAYS. PATHOLOGY REPORT REVEALED 90% RADIATION NECROSIS AND 10% TUMOR CELLS AS OF 05/2004.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization