BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVOTTF-100A

    MDR report key: 3828912 · Received May 8, 2014

    Report

    Report Number
    3009453079-2014-00039
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 22, 2014
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE MEDICAL OPINION IS THAT DEATH WAS NOT RELATED TO NOVOTFF THERAPY. DEATH IS AN EXPECTED EVENT IN PATIENTS WITH RECURRENT GLIOBLASTOMA DUE TO THE NATURAL PROGRESSION OF THE DISEASE. ON THE PIVOTAL PHASE III TRIAL OVERALL SURVIVAL WAS 6.3/6.4 MONTHS IN THE NOVOTTF THERAPY AND CHEMOTHERAPY ARM RESPECTIVELY.

    Description of Event or Problem · 1

    PT WITH RECURRENT GLIOBLASTOMA BEGAN NOVOTTF THERAPY ON (B)(6) 2013. ON (B)(6) 2014, NOVOCURE WAS INFORMED BY THE PT'S SPOUSE THAT THE PT HAD DIED THAT SAME DAY. CAUSE OF DEATH IS UNK. PRESCRIBING MD WAS CONTACTED FOR MORE INFO WITH NO RESPONSE. NO ADVERSE EVENTS ASSOCIATED WITH DEVICE USE WAS REPORTED. THE LAST DATE OF NOVOTTF THERAPY WAS NOT KNOWN UNTIL THE EQUIPMENT WAS RETURNED TO NOVOCURE AND LOGFILES DOWNLOADED ON (B)(6) 2014. PER LOGFILE REVIEW, LAST DEVICE USE WAS (B)(6) 2014, AT 10:35 AND DEVICE WAS FUNCTIONING AS PER NORMAL OPERATING PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278211 NOVOTTF-100A NZK NOVOCURE LTD TFH-9000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death