BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOTTF-100A

    MDR report key: 2997571 · Received February 26, 2013

    Report

    Report Number
    3009453079-2013-00017
    Event Type
    Other
    Date Received
    February 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P10034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: 05/01/2012. NOVOCURE CONCURS WITH THE PRESCRIBING MD THAT CEREBRAL ARTERY INFARCT, VISION PROBLEMS (PRE-EXISTING) AND FALL WERE RELATED TO UNDERLYING PROGRESSIVE GBM, AND UNRELATED TO NOVOTTF THERAPY. CEREBRAL ARTERY INFARCT HAS NOT BEEN PREVIOUSLY REPORTED IN THE PIVOTAL PHASE III RECURRENT GBM TRIAL OR IN POST-MARKETING SURVEILLANCE. PRIOR HISTORY OF BEVACIZUMAB TREATMENT IS ALSO NOTED AS A RISK FACTOR FOR THROMBOTIC EVENTS. VISION PROBLEMS ARE A KNOWN ADVERSE EVENT LISTED IN THE IFU (1% VS. 2%, NOVOTTF THERAPY VS. CHEMOTHERAPY; RELATED 0% AND 1% RESPECTIVELY). VISUAL DEFICITS (I.E. HEMIANOPSIA) ARE ALSO COMMONLY ASSOCIATED WITH PCA INFARCT AND THE UNDERLYING DISEASE (GBM). HEMIANOPSIA AND A PREVIOUS HYPERTENSIVE ISCHEMIC EVENT WERE NOTED PRIOR TO START OF NOVOTTF THERAPY. FALL IS A KNOWN ADVERSE EVENT LISTED IN THE IFU (4% VS. 0%, NOVOTTF THERAPY VS. CHEMOTHERAPY; RELATED 1% AND 0% RESPECTIVELY).

    Description of Event or Problem · 1

    PT WITH RECURRENT GLIOBLASTOMA (SMALL CELL VARIANT OF THE RIGHT OCCIPITAL LOBE) BEGAN NOVOTTF THERAPY ON (B)(6) 2012. ON AN UNK DATE, WHILE ON NOVOTTF THERAPY, THE PATIENT FELL OUT OF BED AND ¿SUSTAINED A LARGE BUMP FROM THE FALL¿ ON HEAD AND WAS SEEN IN THE EMERGENCY ROOM (ER). NO TREATMENT INTERVENTION WAS REQUIRED FOR THIS FALL. NOVOTTF THERAPY WAS TEMPORARILY DISCONTINUED FOR 2 DAYS. ON (B)(6) 2013, CAREGIVER REPORTED THAT PATIENT WAS HAVING VISION PROBLEMS. PATIENT HAD PRE-EXISTING VISION PROBLEMS AND IT IS NOT KNOWN IF VISION PROBLEMS WERE WORSENING. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6), MRI DEMONSTRATED GBM PROGRESSION WITHIN THE OCCIPITAL LOBE WITH ASSOCIATED INFARCT (POSTERIOR CEREBRAL ARTERY INFARCT). CEREBRAL INFARCT IN THE OCCIPITAL AREA WAS CONSIDERED NEW. THERE WAS NO EVIDENCE OF INFARCT/HEMORRHAGE IN REGIONS WITHOUT TUMOR. ACCORDING TO PRESCRIBING MD, THE PATIENT HAD 10-15% TUMOR GROWTH IN THE PAST TWO MONTHS WITH ASSOCIATED DECLINING HEALTH. PER THE PRESCRIBING MD, PATIENT HAD PRIOR HISTORY OF CEREBRAL INFARCT WITH TUMOR INVOLVEMENT IN THE AREA OF THE BASAL GANGLIA. THE PATIENT HAD RECEIVED BEVACIZUMAB PREVIOUSLY FOR THE TREATMENT OF GBM. NOVOTTF THERAPY WAS PERMANENTLY DISCONTINUED AFTER THE MRI DUE TO GBM PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81565 NOVOTTF-100A NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other