BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVO-TTF-100A

    MDR report key: 2818399 · Received October 5, 2012

    Report

    Report Number
    3009453079-2012-00007
    Event Type
    Other
    Date Received
    October 5, 2012
    Report Date
    September 6, 2012
    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

    PT WITH RECURRENT GLIOBLASTOMA EXPERIENCED INCREASE IN SEIZURE ACTIVITY WHILE USING NOVOTTF THERAPY. SINCE TIME OF EVENT PT HAS EXPERIENCED PROGRESSIVE NEUROLOGICAL DECLINE CONSISTENT WITH PROGRESSIVE GLIOBLASTOMA (CONFIRMED BY MRI FINDINGS). NO FURTHER SEIZURE ACTIVITY SINCE DISCONTINUATION OF OXYCODONE AND THE ADDITION OF LEVETIRACETAM AND DEXAMETHASONE TO ANTI-SEIZURE REGIMEN. MD TREATING PT ATTRIBUTES INCREASE IN SEIZURES DUE TO PROGRESSIVE GLIOBLASTOMA, OXYCODONE USE, AND POSSIBLE INTRATUMORAL HEMORRHAGE IN SETTING OF THROMBOCYTOPENIA. TREATING MD INDICATES INCREASE IN SEIZURES POSSIBLY RELATED TO NOVOTTF THERAPY. SEIZURES WERE REPORTED AS ADVERSE EVENTS ON THE PIVOTAL EF-11 RECURRENT GBM TRIAL IN BOTH ARMS OF THE TRIAL (9% AND 4% IN NOVOTTF AND CHEMOTHERAPY ARMS RESPECTIVELY). NONE OF THESE SEIZURES WERE CONSIDERED DEVICE OR CHEMOTHERAPY RELATED BY INVESTIGATORS. SEIZURES ARE A KNOWN COMPLICATION OF THE UNDERLYING DISEASE (RECURRENT GBM). NOVACURE MEDICAL CONCLUSION: SEIZURES RELATED TO PROGRESSIVE GLIOBLASTOMA; POSSIBLY RELATED TO OXYCODONE USE; UNLIKELY RELATED TO NOVOTTF. ADDITIONAL DEVICE MANUFACTURE DATE: 02/01/2012.

    Description of Event or Problem · 1

    PT CAREGIVER CALLED INTO NOVOCURE TECHNICAL SUPPORT LINE ON (B)(6) WITH QUESTION ABOUT USING THE NOVOTTF DEVICE IF PT (DIAGNOSIS RECURRENT GLIOBLASTOMA) WAS EXPERIENCING SEIZURES. MEDICAL INVESTIGATION AND DISCUSSION WITH TREATING PHYSICIAN DETERMINED PT INITIATED NOVOTTF THERAPY IN (B)(6) 2012. ON (B)(6), PT WAS ADMITTED TO HOSP WITH LEG WEAKNESS AND RECURRENT SEIZURE ACTIVITY. RECENT START OF OXYCODONE DISCONTINUED IN HOSP FOR CONCERN OF CONTRIBUTING TO SEIZURES. HE WAS TREATED WITH INTRAVENOUS STEROIDS, LEVETIRACETUM WAS ADDED TO GABAENTIN FOR SEIZURE CONTROL, NOVOTTF THERAPY WAS DISCONTINUED AND HE WAS DISCHARGED TO A SKILLED NURSING FACILITY ON (B)(6). HIS CLINICAL CONDITION CONTINUED TO DECLINE, WITH INABILITY TO USE LEFT ARM, MAINTAIN SITTING POSTURE OR FEED SELF INDEPENDENTLY AND REQUIRED TOTAL CARE AND THUS WAS TRANSFERRED TO A FULL CARE NURSING FACILITY ON (B)(6). ON (B)(6), HE WAS ADMITTED TO HOSP WITH RECURRENT PNEUMONIA AND FURTHER NEUROLOGICAL DECLINE. MRI DEMONSTRATED PROGRESSIVE GLIOBLASTOMA. NO FURTHER SEIZURES REPORTED.

    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 Hospitalization LEVETIRACETAM| INSULIN| DEXAMETHASONE| ENOXAPARIN| GABAPENTIN