BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMATILE

    MDR report key: 16624919 · Received March 27, 2023

    Report

    Report Number
    3014663932-2023-00011
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    July 1, 2020
    Report Date
    March 27, 2023
    Manufacturer
    GT MEDICAL TECHNOLOGIES
    Product Code
    KXK
    PMA / PMN Number
    K190839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS ORIGINALLY TREATED FOR A WHO 1 MENINGIOMA IN (B)(6) 2018. A RECURRENCE OCCURED IN (B)(6) 2019 WHEN THE PATIENT WAS TREATED WITH REPEAT RESECTION AND FULL FRACTIONATED EXTERNAL BEAM RADIATION THERAPY. ADDITIONAL RECURRENCES OCCURRED IN (B)(6) 2019 AND (B)(6) 2020. THE TREATING PHYSICIAN DID NOT FEEL REPEAT EXTERNAL BEAM RADIATION THERAPY WAS SAFE SO RESECTION WITH GAMMATILE WAS PERFORMED. RADIATION NECROSIS WAS IDENTIFIED AND THE PATIENT REQUIRED MEDICAL TREATMENT TO PRECLUDE PERMANENT IMPAIRMENT. DUE TO THE PREVIOUS RADIATION TREATMENT AND THIS BEING RE-RADIATION, IT IS NOT KNOWN WHETHER GAMMATILE CAUSED OR CONTRIBUTED TO THE RADIATION NECROSIS THAT WAS EXPERIENCED.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED RADIATION NECROSIS AFTER TREATMENT WITH GAMMTILE FOR RECURRENT BRAIN TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426866 GAMMATILE RADIONUCLIDE BRACHYTHERAPY SEEDS KXK GT MEDICAL TECHNOLOGIES GT-001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention