BEUDAMED
    FDA Adverse Event Death Summary report: N

    VARIAN

    MDR report key: 906037 · Received August 27, 2007

    Report

    Report Number
    MW5003615
    Event Type
    Death
    Date Received
    August 27, 2007
    Date of Event
    March 16, 2007
    Manufacturer
    VARIAN
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS GIVEN OVERDOSE OF RADIATION TO THE BRAIN STEM ON THREE CONSECUTIVE DAYS FOR CANCER TREATMENT. THE OVERDOSE WAS A RESULT OF MECHANICAL ERROR -A TREATMENT MACHINE MANUFACTURED BY VARION- AS WELL AS TECHNICIAN ERROR. AS A RESULT THE PT DIED NEARLY 2 YEARS LATER, WITH DIMINISHING ABILITIES AND DAMAGED BODY SYSTEMS AND FUNCTION ALONG THE WAY. I BELIEVE A NYS GOVERNMENT OFFICE WAS MADE AWARE OF THIS INCIDENT AND DID SOME SORT OF INVESTIGATION... PERHAPS THIS WAS THE HEALTH DEPT FOR NYS. FREQUENCY: 3 DAYS. DATES OF USE: THREE DAYS IN 2005. DIAGNOSIS: AS TREATMENT FOR TONGUE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN RADIATION MACHINE FOR CANCER IYE VARIAN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death| H| L| R VARION