BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEKSELL GAMMA KNIFE PERFEXION

    MDR report key: 6020986 · Received October 12, 2016

    Report

    Report Number
    9612186-2016-00007
    Event Type
    Death
    Date Received
    October 12, 2016
    Date of Event
    June 21, 2016
    Report Date
    April 27, 2017
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    PMA / PMN Number
    K133565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SUFFERED AN INTRACRANIAL BLEED FOLLOWING AN LGK TREATMENT. THE PATIENT WAS BEING TREATED FOR INTRACRANIAL METASTATIC BRAIN LESIONS, OF ORIGIN FROM MELANOMA. THE PATIENT IS DECEASED. THE DEVICE WAS USED WITHIN ITS INTENDED USE AND WORKED AS INTENDED. TREATMENT WAS PER AVAILABLE INFORMATION PERFORMED IN TWO SESSIONS, WHEREAS COMPLICATIONS OCCURRED AFTER THE SECOND SESSION. UPON CT EXAMINATION A HAEMORRHAGE WAS IDENTIFIED AS BEING ASSOCIATED WITH THE LOCATION FO THE FIRST TREATMENT AND ONE SMALLER ASSOCIATED WITH THE SECOND TREATMENT. THE CAUSE OF DEATH IS NOT KNOWN AS THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR TREATMENT. THE GAMMA KNIFE DID OPERATE AS INTENDED ACCORDING TO THE INFORMATION FROM THE DOCTOR AT SITE. NO NEW RISKS HAVE BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE IN CLINICAL USE.

    Description of Event or Problem · 1

    A PATIENT HAD AN INTRACRANIAL BLEED DURING A GAMMA KNIFE TREATMENT. THE PATIENT WAS BEING TREATED FOR INTRACRANIAL METASTATIC BRIAN LESIONS, OF ORIGIN FROM MELANOMA. WE UNDERSTAND THE PATIENT HAS SINCE PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672857 LEKSELL GAMMA KNIFE PERFEXION SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death