BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTUNE

    MDR report key: 4807951 · Received May 29, 2015

    Report

    Report Number
    3009453079-2015-00056
    Event Type
    Death
    Date Received
    May 29, 2015
    Date of Event
    April 25, 2015
    Report Date
    May 11, 2015
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE MEDICAL OPINION IS THAT THE DEATH WAS NOT RELATED TO OPTUNE THERAPY. DEATH IS AN EXPECTED EVENT IN PTS WITH GLIOBLASTOMA (GBM) DUE TO THE NATURAL HISTORY OF THE DISEASE. PTS WITH NEWLY DIAGNOSED GBM WHO ARE TREATED WITH MAXIMAL SURGICAL RESECTION, 60 GY RADIOTHERAPY TOGETHER WITH TEMOZOLOMIDE, FOLLOWED BY MAINTENANCE TEMOZOLOMIDE FOR 6 MONTHS HAVE A MEDIAN SURVIVAL OF 14.6 MONTHS [STUPP ET AL N ENGL J MED 352 (10): 987-96, 2005].

    Description of Event or Problem · 1

    PT WITH GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2015, NOVOCURE WAS INFORMED BY PT'S SPOUSE THAT THE PT DIED EARLIER THAT MORNING. PRESCRIBING PHYSICIAN WAS CONTACTED FOR ADD'L INFO WITH NO RESPONSE. CAUSE OF DEATH IS UNK. NO ADVERSE EVENTS ASSOCIATED WITH DEVICE USE WERE REPORTED. THE LAST DAY OF OPTUNE THERAPY WAS NOT KNOWN UNTIL THE EQUIPMENT WAS RETURNED TO NOVOCURE AND LOGFILES DOWNLOADED ON (B)(6) 2015. PER LOGFILE REVIEW, LAST DEVICE USE WAS (B)(6) 2015 AT 09:56 AND DEVICE WAS FUNCTIONING AS PER NORMAL OPERATING PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348288 OPTUNE NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death