BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL GAMMA PLAN

    MDR report key: 432609 · Received December 3, 2002

    Report

    Report Number
    1037831-2002-00009
    Event Type
    Other
    Date Received
    December 3, 2002
    Date of Event
    September 12, 2002
    Report Date
    December 2, 2002
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    PT HAS GROWTH ON THE LEFT 5TH CRANIAL NERVE, WHICH IS TREATED AS A SCHWANOMA. PT ALREADY HAD FACIAL NUMBNESS PRIOR TO TREATMENT. TREATMENT WITH LEKSELL GAMMA KNIFE OCCURRED IN 2002. RADIATION ONCOLOGIST REPORTED THAT PLANNED DOSE WAS 14GY TO 50% ISODOSE LINE, MAX DOSE 28GY. THE DELIVERED DOSE WAS 22.4GY TO THE 50% LINE. ACCORDING TO THE RADIATION ONCOLOGIST, 7.5 TO 8.1GY WAS GIVEN TO THE BRAINSTEM, WHICH CAN TAKE UP TO 18 GY. A .016 CC VOLUME OF BRAINSTEM RECEIVED 20GY. SYMPTOMS OF TOXICITY WOULD BE NUMBNESS, HOWEVER TOXICITY COULD NOT BE MEASURED BECAUSE OF PRIOR NUMBNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA PLAN RADIATION THERAPY IWB ELEKTA INSTRUMENT AB VERSION 5.33 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other