BEUDAMED
    FDA Adverse Event Death Summary report: N

    WHOLE BRAIN RADIATION

    MDR report key: 6556792 · Received May 9, 2017

    Report

    Report Number
    MW5069656
    Event Type
    Death
    Date Received
    May 9, 2017
    Date of Event
    July 27, 2016
    Report Date
    May 8, 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

    CLINICAL T3NSM1 GENTLEMAN WITH METASTATIC DISEASE TO LIVER, BRAIN, BILATERAL LUNG, POSSIBLY BONE, MEDIASTINUM, MESENTERIC LYMPH NODE AND BRAIN METS IDENTIFIED ON (B)(6) 2016. PT BEGAN WHOLE BRAIN RADIATION ON (B)(6) 2016. PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 WITH ALTERED MENTAL STATUS AND FREQUENT FALLS. CT OF HEAD/BRAIN; CHEST/ABD/PELVIS BOTH PERFORMED (B)(6) 2016 SHOWED MULTIPLE INFRATENTORIAL AND SUPRATENTORIAL METASTASES. WORSENING METASTATIC DISEASE IN THE CHEST AND OSSEOUS STRUCTURES, MULTIPLE LIVER METASTASIS AND FOCAL LESIONS IN THE RIGHT KIDNEY. PT WAS DISCHARGED TO HOSPICE ON (B)(6) 2016. PT PASSED AWAY IN HOSPICE ON (B)(6) 2016. THERAPY DATES: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: BRAIN METASTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336748 WHOLE BRAIN RADIATION RADIATION THERAPY TREATMENT SYSTEM MUJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H 12 DAYS X 400 CGY| WHOLE BRAIN RADIATION