BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL GAMMA KNIFE

    MDR report key: 354041 · Received September 25, 2001

    Report

    Report Number
    9612186-2001-00004
    Event Type
    Other
    Date Received
    September 25, 2001
    Date of Event
    August 30, 2001
    Report Date
    September 25, 2001
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MISADMINISTRATION OCCURRED, INVOLVING A GAMMA KNIFE, THAT RESULTED IN AN ADMINISTERED DOSE THAT WAS ABOUT 39 PERCENT GREATER THAN THE PRESCRIBED DOSE. A PT WHO WAS PRESCRIBED A DOSE OF 20 GRAY (2000 RAD) RECEIVED 27.8 GRAY (2780 RAD) DUE TO A TREATMENT TIME ENTRY ERROR DURING A 2001 TREATMENT SESSION. THE RADIATION DOSE WAS GREATER THAN PRESCRIBED BECAUSE THE TREATMENT DURATION WAS 7.18 MINS LONGER THAN PRESCRIBED. THIS TREATMENT WAS THE FIRST IN A SERIES OF FOUR GEOGRAPHICALLY DISTINCT TREATMENTS AND EXPECTED TO LAST FOR 18.43 MINS. THE TREATMENT AT THIS GEOGRAPHICAL LOCATION OF THE BRAIN WAS TERMINATED WHEN IT WAS RECOGNIZED THAT THE ELAPSED TIME EXCEEDED THE PRESCRIBED TIME. THE REMAINING THREE TREATMENT SITES WERE SUBSEQUENTLY TREATED IN ACCORDANCE WITH THE PT'S TREATMENT PLAN. THE HOSP HAS INFORMED THE PT AND THE PT'S PHYSICIAN. THE LICENSEE REPORTED THAT NO ADVERSE EFFECTS WERE EXPECTED AS A RESULT OF THE MISADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43391 LEKSELL GAMMA KNIFE RADIATION THERAPY IWB ELEKTA INSTRUMENT AB 24001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other