BEUDAMED
    FDA Adverse Event Death Summary report: N

    SBRT

    MDR report key: 4538362 · Received February 13, 2015

    Report

    Report Number
    MW5040803
    Event Type
    Death
    Date Received
    February 13, 2015
    Date of Event
    December 19, 2014
    Report Date
    February 12, 2015
    Product Code
    IXQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2013. THE PATIENT RECEIVED SBRT ON (B)(6) 2013 FOR A TOTAL OF 2400CGY. THE PATIENT HAD BEEN IN FOLLOW-UP WITHOUT RECURRENCE OF DISEASE AS OF LAST SCAN DONE IN (B)(6) 2014. PER FAMILY, PATIENT DEVELOPED COUGHING WITH SEVERE HEMOPTYSIS, PATIENT ARRIVED VIA EMS AT OUTSIDE MEDICAL CENTER IN CARDIAC ARREST AND EXPIRED IN THE ED ON (B)(6) 2014. THE PI HAS DETERMINED THAT THE EVENT IS A RARE OCCURRENCE AND LATE TOXICITY, LIKELY RELATED TO SBRT WHERE THE LARGE BLOOD VESSELS AROUND THE HEART MAY HAVE HEMORRHAGED. THE CTCAE 4.03 GRADABLE EVENT OF BRONCHOPULMONARY HEMORRHAGE GRADE 5 IS BEING REPORTED AND IS LIKELY RELATED TO SBRT. CARDIAC ARREST IS SECONDARY TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AND AUTOPSY WAS NOT PERFORMED PER FAMILY WISHES. DIAGNOSIS FOR USE: ADENOCARCINOMA LUNG, SBRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108164 SBRT SBRT IXQ

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death