BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 20083387 · Received August 28, 2024

    Report

    Report Number
    3010457505-2024-00321
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 28, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE PATIENT EXPERIENCED PSYCHOLOGICAL STRESS DUE TO OPTUNE GIO THERAPY, THEREFORE A CONTRIBUTION OF THE DEVICE TO THE PATIENT'S DISTRESS CANNOT BE RULED OUT. STRESS IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND <1% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 64-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON (B)(6) 2024, THAT THE PATIENT HAD EXPERIENCED SEVERE DEPRESSION WITH PANIC ATTACKS. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 01, 2024, THAT THE PATIENT WAS UNABLE TO MENTALLY TOLERATE OPTUNE GIO THERAPY. REPORTEDLY, A PANIC ATTACK WAS TRIGGERED WHEN THE ARRAYS WERE APPLIED TO THE SCALP THAT SUBSEQUENTLY REQUIRED LORAZEPAM IN THE ACUTE SITUATION. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER INFORMATION AND STATED THAT IT WAS UNKNOWN WHETHER THE PATIENT EXPERIENCED DEPRESSION OR PANIC ATTACKS BEFORE STARTING OPTUNE GIO THERAPY. THE PRESCRIBER TREATED THE PATIENT AS AN OUTPATIENT AND PRESCRIBED OPTUNE GIO THERAPY AND RELAXATION MEASURES. ACCORDING TO THE PRESCRIBER THE CAUSE OF THE INCIDENT WAS A COMBINATION OF THE PATIENT'S UNDERLYING PERSONALITY, ILLNESS AND OPTUNE GIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464744 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention DOMPERIDONE| IBUPROFEN| LACOSAMIDE| LEVETIRACETAM| LEVOTHYROXINE| METAMIZOLE| MIRTAZAPINE| PANTOPRAZOLE| TEMZOLOMIDE| ZOLPIDEM