BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL GAMMA PLAN

    MDR report key: 432746 · Received December 3, 2002

    Report

    Report Number
    1037831-2002-00005
    Event Type
    Other
    Date Received
    December 3, 2002
    Date of Event
    September 11, 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 WITH ACOUSTIC SCHWANOMA ON 8TH CRANIAL NERVE. PT PREVIOUSLY HAD SURGERY ON THE SAME. PT HAD HEARING LOSS PRIOR TO TREATMENT WITH LEKSELL GAMMA KNIFE. TREATMENT WITH LEKSELL GAMMA KNIFE OCCURRED IN 2002. RADIATION ONCOLOGIST REPORTED THAT PLANNED DOSE WAS 12GY TO 50% ISODOSE LINE, MAX DOSE 24GY. THE DELIVERED DOSE WAS 19.2GY TO 50% ISODOSE LINE, 38.3GY MAX. A 0.119CC VOLUME OF THE BRAINSTEM REC'D GREATER THAN 18GY. ACCORDING TO THE RADIATION ONCOLOGIST, THE DOSE TO THE BRAINSTEM WAS IN A SAFE REGION AND THE INCREASED DOSE MAY ACTUALLY HELP CONTROL THE TUMOR.

    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