BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL GAMMA KNIFE

    MDR report key: 2556511 · Received April 26, 2012

    Report

    Report Number
    9612186-2012-00001
    Event Type
    Other
    Date Received
    April 26, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ELEKTA INSTRUMENT, AB.
    Product Code
    IWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERE HAS BEEN A DISCREPANCY BETWEEN THE DOSES GIVEN IN A VARIETY OF DIFFERENT TREATMENT POSITIONS. THIS HAS NOT HELPED WHEN THE TREATMENT WAS INTERRUPTED WHEN THE STEREOTACTIC FRAME HAD TO BE REAPPLIED, AFTER THE PT HAD A FALL DURING A BATHROOM BREAK. THREE SITES RECEIVED DOSES GREATER THAN ORIGINALLY PLANNED. THE DELIVERED DOSES WERE RECONSTRUCTED FOR REVIEW AND IT WAS ESTABLISHED THAT THESE DOSES WERE WELL WITHIN CLINICAL PRACTICE, AND THERE IS NO REASON FOR THE PT TO BE CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA KNIFE SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT, AB. MODEL 4C NA

    Patients

    Seq Age Sex Outcome Treatment
    1