BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIATION THERAPY TREATMENT

    MDR report key: 6739714 · Received July 21, 2017

    Report

    Report Number
    MW5071177
    Event Type
    Death
    Date Received
    July 21, 2017
    Date of Event
    July 20, 2017
    Report Date
    July 21, 2017
    Manufacturer
    UNK
    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

    VOLUNTARY SUBMISSION OF REPORT FOR PT WHO PASSED AWAY WHILE ON TREATMENT ON INSTITUTIONAL TRIAL OF WHOLE BRAIN RADIATION FOR TREATMENT OF MULTIPLE METASTASES. PT WITH NSCLC METASTATIC TO BRAIN ON INSTITUTIONAL PROTOCOL FOR WBRT USING IMRT TO SPARE THE HIPPOCAMPUS. PER PT'S WIFE, PT FELL ASLEEP IN HIS CHAIR AND PASSED AWAY IN HIS SLEEP. CORONER OF (B)(6) INDICATED TO TREATING RADIATION ONCOLOGIST, DR (B)(6), NO FOUL PLAY OR TRAUMA INVOLVED. PER DR (B)(6), DEATH WAS PRESUMED TO BE PROGRESSIVE DISEASE AND ADVANCED AGE. PT DIED IN HIS HOME, NO HOSPITALIZATION OR TESTS PERFORMED. WAS TAKEN TO MEDICAL INVESTIGATOR. CORONER REPORT IS PENDING. PER STUDY PROTOCOL, WBRT USING IMRT TO SPARE HIPPOCAMPUS. RECEIVED 7 FRACTIONS WBRT AND 4 FRACTIONS PALLIATIVE RT TO HIP AT TIME OF DEATH. RECEIVED 400 CGY TO BRAIN DAILY. CUMULATIVE DOSE 2800 CGY AT TIME OF DEATH. RECEIVED 400 CGY DAILY TO HIP BEGINNING (B)(6) 2017. RECEIVED 4 FRACTIONS. CUMULATIVE DOSE 1600 CGY AT TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514158 RADIATION THERAPY TREATMENT RADIATION THERAPY TREATMENT MUJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death