BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEKSELL GAMMA KNIFE 4C

    MDR report key: 3172544 · Received June 17, 2013

    Report

    Report Number
    9612186-2013-00004
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 17, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    PMA / PMN Number
    K984328
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS INCIDENT IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADDITIONAL INFORMATION TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION CONCLUDED THAT IT WAS APPARENT THAT THE PLAN AND THE VERIFICATION WERE COMPLETED INCORRECTLY BY THE RESPONSIBLE CLINICIANS. THE EQUIPMENT PERFORMED AS INTENDED DURING PLANNING AND TREATMENT. PLEASE NOTE THAT THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A SECOND GAMMA KNIFE TREATMENT ON (B)(6) 2013 WHEN THE TREATMENT WAS DELIVERED TO THE WRONG SIDE OF THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273786 LEKSELL GAMMA KNIFE 4C SYSTEM, RADIATION THERAPY, RADIONUCLIDE, IWB ELEKTA INSTRUMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other