BEUDAMED
    FDA Adverse Event Death Summary report: N

    TOMOTHERAPY SYS

    MDR report key: 4307426 · Received December 4, 2014

    Report

    Report Number
    3003873069-2014-00003
    Event Type
    Death
    Date Received
    December 4, 2014
    Date of Event
    November 5, 2014
    Report Date
    December 3, 2014
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING REVIEW OF A MANUSCRIPT TITLED "FEASIBILITY AND EFFICACY OF HELICAL TOMOTHERAPY IMRT FOR STAGE II NON-SMALL CELL LUNG CANCER: FEASIBLE AND EFFICACY IN COMPARISON WITH CONVENTIONALLY FRACTIONATED VIA THREE-DIMENSION CONFORMAL RADIOTHERAPY3D-CRT----: A PHASE I/TO II CLINICAL TRIAL" AN ADVERSE EVENT WAS NOTED. ONE PT WITH A PARAESOPHAGEAL TUMOR DEVELOPED A FATAL HEMOPTYSIS AND DIED OF AN ESOPHAGOTRACHEAL FISTULA AT 13TH MONTHS AFTER THE START OF RADIOTHERAPY. TO DATE, THERE IS NO DATA TO SUGGEST THIS WAS DUE TO A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782830 TOMOTHERAPY SYS TOMOTHERAPY MUJ ACCURAY INCORPORATED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death