BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVO-TTF-100A

    MDR report key: 2582567 · Received May 18, 2012

    Report

    Report Number
    3009453079-2012-00003
    Event Type
    Death
    Date Received
    May 18, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    NOVOCURE LTD.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO NOVOCURE FOR EVALUATION ON (B)(4) 2012. EVALUATION OF THE LOGFILE CONFIRMED THE DEVICE WAS OPERATING NORMALLY. NO REMEDIAL ACTION INITIATED. LOGFILE INDICATED PATIENT DISCONTINUED THERAPY ON (B)(6) 2012 AT 21:07 EST. THERE HAVE BEEN NO OTHER REPORTS OF CEREBRAL HEMORRHAGE ON THE NOVO-TTF-100A COMMERCIAL PROGRAM. ON THE PHASE III CLINICAL TRIAL OF NOVO-TTF-100A VERSUS CHEMOTHERAPY THERE WAS ONE CEREBRAL HEMORRHAGE REPORTED IN A PATIENT BEING TREATED WITH THE NOVO-TTF-100A. THE INVESTIGATOR DID NOT CONSIDER THIS DEVICE-RELATED. IN THE MEDICAL LITERATURE INTRACRANIAL HEMORRHAGE HAS BEEN REPORTED IN 2-8 PERCENT OF PATIENTS WITH GLIOBLASTOMA. (WHITE ET AL. J NEUROSURGERY, 2008; LOEFFLER, DE GROOT ET AL., CANCER MANAGEMENT, 2011). IN THS CASE, BASED ON THE PATIENT HISTORY OF RECURRENT GBM AND ASSOCIATED INITIATION OF ANTICOAGULATION ONE WEEK PRIOR TO THE EVENT OF BRAIN HEMORRHAGE, NOVOCURE CONCURS WITH THE PHYSICIAN ASSESSMENT AS UNRELATED TO NOVO-TTF-100A.

    Description of Event or Problem · 1

    PATIENT WITH RECURRENT GLIOBLASTOMA WAS ADMITTED TO HOSPITAL FOR DECLINING MENTAL STATUS AND BRAIN HEMORRHAGE ON (B)(6) 2012. PATIENT DIED IN HOSPITAL ON THE SAME DAY. CAUSE OF DEATH (AS PER TREATING PHYSICIAN), WAS BRAIN HEMORRHAGE SECONDARY TO RECURRENT GBM AND CONCOMITANT ANTICOAGULATION. PHYSICIAN CONSIDERED THIS ADVERSE EVENT AS UNRELATED TO NOVO-TTF-100A TREATMENT. PATIENT HAD BEEN RECEIVING TREATMENT WITH NOVO-TTF-100A AND HAD DISCONTINUED TREATMENT ON (B)(6) 2012. PATIENT HAD BEEN STARTED ON ANTICOAGULATION WITH LOVENOX ONE WEEK PRIOR TO HOSPITAL ADMISSION FOR DIAGNOSIS OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVO-TTF-100A NZK NOVOCURE LTD. TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| H