BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRAIN LAB V. 3.0.2 TREATMENT PLANNING SOFTWARE

    MDR report key: 2122948 · Received June 7, 2011

    Report

    Report Number
    2122948
    Event Type
    Death
    Date Received
    June 7, 2011
    Date of Event
    February 28, 2008
    Report Date
    June 6, 2011
    Manufacturer
    BRAINLAB, INC.
    Product Code
    MUJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) PT WITH STAGE IV LARYNX CANCER IN FOR MULTIPLE RADIATION TREATMENTS IN 2008. PT RECEIVED A TOTAL OF 33 TREATMENTS. SEVERAL MONTHS LATER, PT BEGAN HAVING NUMBNESS IN HIS FEET WHICH PROGRESSED GRADUALLY OVER TIME AND INCLUDED TINGLING. IT WAS BELIEVED TO BE NORMAL SIDE EFFECTS OF CHEMOTHERAPY. SCANS TO THE TREATED AREA DEMONSTRATED NO FURTHER CANCER LESIONS. BY (B)(6) 2010, PT WAS EXPERIENCING WORSENING NEUROPATHY IN BOTH LEGS AND LEFT HAND. BY (B)(6) 2011, PT'S LEFT LEG HAD INCREASED NUMBNESS CAUSING TRIPPING OVER HIS RIGHT LEG. HIS LEFT HAND ALSO HAD INCREASED NUMBNESS. IN ADDITION, HE BEGAN EXPERIENCING INCONTINENCE OF URINE. REPEAT MRI AND PET SCAN DEMONSTRATED LESIONS TO THE CERVICAL AREA BUT NO ADDITIONAL METASTASIS FROM LARYNX CANCER. THE MEDICAL PHYSICIST REVIEWED HISTORY OF RADIATION TREATMENTS AND NOTED A PROBABLE ERROR IN THE DELIVERY OF THE 2008 TREATMENTS. THE SETUP POSITION (ISOCENTER) ON AN APPROVED TREATMENT PLAN DONE ON THE SYSTEM A BRAINLAB TREATMENT PLANNING SYSTEM WAS EXPORTED TO SYSTEM B VARIAN ECLIPSE ARIA FOR TREATMENT DELIVERY. THE ISOCENTER PLANNED IN SYSTEM A WAS NOT CORRECTLY CAPTURED IN SYSTEM B WHICH REQUIRED HUMAN INTERVENTION TO CORRECT. THE PLANNED SETUP POSITION WAS NOT THE ONE USED FOR TREATMENT. AS A RESULT, THE PT RECEIVED DOSES DIRECTLY TO THE SPINAL CORD THAT EXCEEDED THE NORMAL TOLERANCE FOR THAT ORGAN. (B)(6) 2008. RADIATION TREATMENT OCCURRED AT VARIOUS APPOINTMENT TIMES DURING THIS TIME FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAIN LAB V. 3.0.2 TREATMENT PLANNING SOFTWARE BRAIN LAB IPLAN RT DOSE 3.0.2 MUJ BRAINLAB, INC.
    2 VARIAN ECLIPSE TREATMENT PLANNING AND ARIA RECORD & VER SYSTEMS VARIAN MEDICAL SYSTEMS ECLIPSE ARIA MUJ VARIAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| S