BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 12883336 · Received November 29, 2021

    Report

    Report Number
    3010457505-2021-00192
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 29, 2021
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107982221
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE SEIZURE WAS RELATED TO THE UNDERLYING DISEASE (GBM) AND UNRELATED TO OPTUNE THERAPY. RISK FACTORS FOR SEIZURE IN THIS PATIENT INCLUDE: CONCOMITANT TEMOZOLOMIDE (CONVULSIONS ARE LISTED AS AMONG THE MOST COMMON ADVERSE REACTIONS. SOURCE: TEMOZOLOMIDE PRESCRIBING INFORMATION) AND CONCOMITANT DEXAMETHASONE (CONVULSION IS LISTED AS A KNOWN ADVERSE REACTION. SOURCE: DEXAMETHASONE PRESCRIBING INFORMATION). SEIZURES WERE REPORTED AS ADVERSE EVENTS IN THE EF-14 TRIAL OF OPTUNE TOGETHER WITH TEMOZOLOMIDE (TMZ) COMPARED TO TMZ ALONE IN PATIENTS WITH NEWLY DIAGNOSED GBM IN BOTH ARMS OF THE TRIAL (22% AND 21% IN OPTUNE/TMZ AND TMZ ARMS RESPECTIVELY). NONE OF THESE SEIZURES WERE CONSIDERED DEVICE OR CHEMOTHERAPY RELATED BY INVESTIGATORS. SEIZURES ARE A KNOWN COMPLICATION OF GBM AND HAVE BEEN REPORTED AS THE PRESENTATION SYMPTOM IN 27% OF CASES. DURING THE COURSE OF THE DISEASE, 51% OF PATIENTS WILL EXPERIENCE SEIZURES (CLIN NEUROL NEUROSURG. 2015; 139:166-171).

    Description of Event or Problem · 0

    A (B)(6) MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2021. ON (B)(6) 2021, THE SPOUSE REPORTED TO NOVOCURE THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO SEIZURE ACTIVITY. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. THE PATIENT HAD A HISTORY OF SEIZURES AND WAS TAKING ANTI-SEIZURE MEDICATION (LACOSAMIDE 50 MG BID). PER THE HOSPITAL DISCHARGE SUMMARY, THE SPOUSE STATED SHE HEARD THE PATIENT STATE THAT THE OPTUNE DEVICE WAS SHOCKING HIM AND FOUND HIM EXPERIENCING A TONIC-CLONIC SEIZURE. EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. EMS ADMINISTERED A SEDATIVE (MIDAZOLAM) EN ROUTE AND THE PATIENT RECEIVED LORAZEPAM IN THE ED. TEMPERATURE 97.5, PULSE 85, RESPIRATORY RATE 21, BLOOD PRESSURE 144/88, AND PULSE OXIMETRY 99% ON ROOM AIR. THE PATIENT WAS ADMITTED FOR SEIZURE AND STARTED ON INTRAVENOUS ANTI-SEIZURE LOADING DOSE (LEVETIRACETAM 3000 MG). THE PATIENT WAS ABLE TO FOLLOW A FEW SIMPLE COMMANDS BUT REMAINED NONVERBAL. TELEMETRY NEUROLOGY CONSULT RECOMMENDED AN MRI, EEG, AND TO INCREASE IV ANTI-SEIZURE MEDICATION (LACOSAMIDE) TO 800 MG EVERY 8 HOURS. ED PHYSICIAN NOTED THE SEIZURE ACTIVITY WAS LIKELY TRIGGERED BY "ELECTRIC SHOCK". THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL SEIZURES DURING THE HOSPITALIZATION. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH INSTRUCTIONS TO CONTINUE WITH LACOSAMIDE 100 MG BID AND FOLLOW UP WITH PHYSICAL THERAPY DUE TO RESIDUAL LEFT SIDED WEAKNESS. PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE SEIZURE ACTIVITY. DEVICE WAS RETURNED TO MANUFACTURER AND NO FUNCTIONAL ISSUES WERE IDENTIFIED DURING INVESTIGATION. DEVICE POWERED ON AND PASSED ALL SAFETY AND FUNCTIONAL TESTS. DEVICE LOGFILE REVIEW SHOWED NO ERRORS THAT WOULD INDICATE AN ELECTRICAL MALFUNCTION AND NO ALARMS RELATED TO TFH FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783780 OPTUNE OPTUNE NZK NOVOCURE GMBH TFH9100 N/A 07290107982221

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization ASPIRIN| DEXAMETHASONE| PANTOPRAZOLE| RAMIPRIL| TAMSULOSIN| TEMAZEPAM| TEMOZOLOMIDE| TIOTROPIUM| TIOTROPIUM BROMIDE INHALER| TRANYLCYPROMINE