BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVOTTF-100A

    MDR report key: 3788199 · Received April 30, 2014

    Report

    Report Number
    3009453079-2014-00038
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    January 31, 2014
    Report Date
    April 2, 2014
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE CONCURS WITH PRESCRIBER THAT DEATH WAS NOT RELATED TO NOVOTTF THERAPY. DEATH WAS MOST LIKELY RELATED TO GLIOBLASTOMA PROGRESSION OR CORONARY ARTERY DISEASE. DEATH IS AN EXPECTED EVENT IN PTS 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) 2014. THE PT'S SPOUSE REPORTED THAT THE PT HAD BEEN HOSPITALIZED DUE TO LEFT SIDE WEAKNESS AND TUMOR PROGRESSION. ON (B)(6) 2014, PRESCRIBING PHYSICIAN REPORTED THAT THE PT HAD BEEN DISCHARGED ON (B)(6) 2014 TO HOSPICE WITH PLANS TO CONTINUE NOVOTTF THERAPY WHILE IN HOSPICE. PT DIED ON (B)(6) 2014 AFTER EXPERIENCING CHEST PAIN. PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR CORONARY ARTERY DISEASE AND ANGINA. PER PRESCRIBER, DEATH WAS NOT RELATED TO NOVOTTF THERAPY. IMMEDIATE CAUSE OF DEATH WAS UNK. NO ADVERSE EVENTS ASSOCIATED WITH DEVICE USE WERE 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 04:00 AND DEVICE WAS FUNCTIONING AS PER NORMAL OPERATING PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260413 NOVOTTF-100A NZK NOVOCURE LTD TFH-9000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death LOSARTAN| RANITIDINE| AMLODIPINE| ASPIRIN| MIRTAZAPINE| PROCHLORPERAZINE| ONDANSETRON| METOPROLOL TARTRATE| ALPRAZOLAM| RANOLAZINE| PRAVASTATIN| NITROGLYCERIN| ISOSORBIDE MONONITRATE| TOPIRAMATE