BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOTHERAPY SYSTEM

    MDR report key: 5067287 · Received September 8, 2015

    Report

    Report Number
    3003873069-2015-00002
    Event Type
    Injury
    Date Received
    September 8, 2015
    Report Date
    August 5, 2015
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    MUJ
    PMA / PMN Number
    K112776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OF DEVICE MALFUNCTION. RADIATION NECROSIS IS A KNOWN SIDE EFFECT OF RADIATION THERAPY. PERSISTENT BILATERAL TRIGEMINAL NEURALGIA MANIFESTED POST SURGERY AND CAN RESULT FROM DISEASE PROGRESSION AND THE SECONDARY STANDARD RIGHT TEMPORAL LOBECTOMY ALTHOUGH A CONTRIBUTING FACTOR OF A TREATMENT WITH THE TOMOTHERAPY SYSTEM CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    AN INTERNAL ACCURAY EMPLOYEE FOUND A CLINICAL PAPER TITLED "RADIATION NECROSIS SECONDARY TO TRIGEMINAL NERVE TOMOTHERAPY; A CAUTIONARY CASE STUDY" DURING A LITERATURE SEARCH WHICH DESCRIBED A (B)(6) PATIENT HAVING BEEN TREATED FOR RECURRENCE OF A CANCER TUMOR. THE PAPER NOTED THAT AT ONE YEAR POST TREATMENT THE PATIENT STARTED TO EXPERIENCE CONFUSION, REDUCED VISION FIELD AND PERSISTENT BILATERAL TRIGEMINAL NEURALGIA (TN). THE PATIENT HAD UNDERGONE TREATMENT ON A TOMO THERAPY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593995 TOMOTHERAPY SYSTEM TOMOTHERAPY SYSTEM MUJ ACCURAY INCORPORATED NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability