BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 3012320 · Received March 15, 2013

    Report

    Report Number
    2950679-2013-00003
    Event Type
    Death
    Date Received
    March 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ACCURAY, INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A REVIEW OF A DRAFT CLINICAL PUBLICATION, AN ACCURAY EMPLOYEE NOTICED AN ADVERSE EVENT DESCRIBED. THE PUBLICATION DESCRIBES A STUDY OF 26 PTS TREATED FROM 2007-2011. THE PTS WERE CONSIDERED INOPERABLE PTS WITH LOCALIZED LUNG TUMORS. ON PT, WHO WAS PRESENTED WITH STEROID-REFRACTORY RADIATION PNEUMONITIS AT EIGHT MONTHS POST-TREATMENT, DIED OF ACUTE RESPIRATORY FAILURE FOUR MONTHS LATER. THE PT HAD UNDERGONE A LEFT PNEUMONECTOMY PRIOR TO RECEIVING RADIATION TREATMENT. THE COMPLICATION IS A KNOWN RISK OF TREATING A TUMOR WITHIN THE GIVEN TREATMENT PARAMETERS AND TUMOR LOCATION. THE PHYSICIAN INDICATED THAT THE PLANNED TREATMENT WAS DELIVERED AS INTENDED AND THAT THE AE WAS NOT DUE TO A MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110487 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death