BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 3069402 · Received April 17, 2013

    Report

    Report Number
    2950679-2013-00005
    Event Type
    Death
    Date Received
    April 17, 2013
    Date of Event
    January 1, 2004
    Report Date
    March 19, 2013
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K091999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS NOT AN ACCURAY SPONSORED STUDY. ACCURAY REGULATORY AFFAIRS PERSONNEL CONTACTED THE PRINCIPLE INVESTIGATOR OF THE STUDY FOR FURTHER DETAILS CONCERNING THE ADVERSE EVENTS. THE PRINCIPLE INVESTIGATOR COMMENTED THE TOLERANCE OF THE ESOPHAGUS TO THERAPEUTIC RADIATION WAS NOT WELL UNDERSTOOD, AND THE STUDY WAS UNDERTAKEN WITH A VIEW TO ESTABLISHING DOSE SAFETY GUIDELINES. THE STUDY CONCLUDED HIGH DOSES OF RADIATION TO THE ESOPHAGUS WITH CONCURRENT CHEMOTHERAPY ARE NOT WELL TOLERATED AND MORE CONSERVATIVE TREATMENT REGIMES THAN THOSE CURRENTLY UTILIZED SHOULD BE CONSIDERED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN ACCURAY EMPLOYEE LEARNED OF THE DEATHS OF TWO PTS DETAILED IN A RESEARCH PAPER (DISEASES OF THE ESOPHAGUS 2012, V:25, PG 623-629, TITLE: ESOPHAGEAL TOLERANCE TO HIGH-DOSE STEREOTACTIC ABLATIVE RADIOTHERAPY). ONE PT RECEIVED TREATMENTS FOR A LUNG TUMOR IN PARALLEL WITH CHEMOTHERAPY. SIX MONTHS AFTER TREATMENT, THE PT DEVELOPED FATAL HEMOPTYSIS (COUGHING UP OF BLOOD). THE SECOND PT RECEIVED TREATMENTS FOR A SPINAL TUMOR PARALLEL WITH CHEMOTHERAPY. FOUR MONTHS POST TREATMENT, THE PT DEVELOPED AN ESOPHAGEAL PERFORATION AND INFECTION LEADING TO DEATH. THE DOCTOR CONFIRMED THE PTS HAD BEEN TREATED CORRECTLY AND THE SYSTEM HAD NOT MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165254 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM IYE ACCURAY INCORPORATED CYBERKNIFE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death| O