BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 1957835 · Received January 6, 2011

    Report

    Report Number
    2950679-2011-00001
    Event Type
    Death
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K091999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    COMPLICATIONS WERE DESCRIBED IN A CLINICAL PUBLICATION TITLED, 'STEREOTACTIC BODY RADIATION THERAPY FOR HEAD AND NECK TUMOR: DISEASE CONTROL AND MORBIDITY OUTCOMES.' ACCURAY CONTACTED THE PHYSICIAN RESPONSIBLE FOR THE TREATMENTS. IT WAS CONFIRMED THAT THE COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PTS DID NOT HAVE ANY OTHER TREATMENT ALTERNATIVE DUE TO THE NATURE AND EXTENT OF DISEASE; CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THESE PTS. THE PTS RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYSTEM IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. THE REPORTED TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY INCORPORATED CYBERKNIFE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death| O