BEUDAMED
    FDA Adverse Event Death Summary report: N

    WHOLE BRAIN RADIATION

    MDR report key: 6559780 · Received May 9, 2017

    Report

    Report Number
    MW5069676
    Event Type
    Death
    Date Received
    May 9, 2017
    Date of Event
    October 3, 2016
    Report Date
    May 9, 2017
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    T3N3M1B PT WITH SUPRACLAVICULAR, MEDIASTINAL, HILAR LYMPHADENOPATHY WITH SEVERAL BRAIN METASTATIC LESIONS. PT ALSO HAD METASTASES TO LEFT ADRENAL GLAND AND LIVER. BEGAN WHOLE BRAIN RADIATION TREATMENT ON (B)(6) 2016 COMPLETING 15 FRACTIONS TOTAL DOSE 6000CGY ON (B)(6) 2016. SOME ADD'L RADIATION OFF STUDY WAS GIVEN TO HIP SPINE, AND SACRUM (B)(6) 2016. PT WAS ADMITTED TO HOSPITAL ON (B)(6) 2016 WITH ACUTE HYPOXIC RESPIRATORY FAILURE SECONDARY TO A RIGHT PLEURAL EFFUSION, LIKELY MALIGNANT, WITH NEAR COMPLETE ATELECTASIS OF THE PT'S RIGHT LUNG. IT WAS PLANNED THAT THE PT WOULD BE DISCHARGED TO HOSPICE, HOWEVER, PT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2016. THERAPY DATES: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: BRAIN METASTASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336257 WHOLE BRAIN RADIATION WHOLE BRAIN RADIATION MUJ

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death