BEUDAMED
    FDA Adverse Event Death Summary report: N

    WHOLE BRAIN RADIATION

    MDR report key: 6556835 · Received May 9, 2017

    Report

    Report Number
    MW5069657
    Event Type
    Death
    Date Received
    May 9, 2017
    Date of Event
    January 18, 2017
    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

    PT DIAGNOSED WITH TRIPLE-NEGATIVE BREAST CANCER 2012, WHICH RECURRED 2015 FOUND TO HAVE MULTIPLE BRAIN METASTASES ON (B)(6) 2016. PT BEGAN RADIATION TREATMENT ON STUDY (B)(6) 2016. RECEIVED 10 OF 15 FRACTIONS UNTIL TAKEN OFF STUDY 01/05/2017 DUE TO PROGRESSIVE DISEASE. PT HAD BEEN IN FOR TWO THORACENTESIS PRIOR TO HOSPITAL ADMISSION PT WAS THEN ADMITTED TO THE HOSPITAL (B)(6) 2017 PRESENTING WITH SHORTNESS OF BREATH. CT CHEST ANGIO NONCORONARY (B)(6) 2017 SHOWED SIGNIFICANT PROGRESSION OF PULMONARY RIGHT PLEURAL EFFUSION AND NOTABLE MEDIASTINAL MALIGNANCY ENLARGEMENT ALONG WITH ENLARGING BILATERAL ADRENAL METASTASES. PT WAS TRANSFERRED TO HOSPICE FOR COMFORT CARE (B)(6) 2017 AND PASSED AWAY IN HOSPICE ON (B)(6) 2017. THERAPY DATES: (B)(6) 2016 - (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: BRAIN METASTASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336992 WHOLE BRAIN RADIATION RADIATION THERAPY TREATMENT SYSTEM MUJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death 15 FRACTIONS OF A PLANNED 60 GY| WHOLE BRAIN RADIATION (B)(6)2016-(B)(6)2017, 10 OF