BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 23725686 · Received December 5, 2025

    Report

    Report Number
    3010457505-2025-00640
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 5, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986427
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF OPTUNE GIO THERAPY TO THE PATIENT'S DISCOMFORT CANNOT BE RULED OUT. MEDICAL DEVICE DISCOMFORT IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 UNKNOWN AND <1% EF-14 OPTUNE ARM). ADDITIONAL NOTE: MANUFACTURING DATE OF (B)(6) IS APRIL 08, 2019.

    Description of Event or Problem · 0

    A 74-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2025. ON NOVEMBER 11, 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT ON (B)(6) 2025, THE PATIENT REPORTED DISCOMFORT, PARTICULARLY WHEN SLEEPING WITH THE OPTUNE GIO DEVICE. AS THE ISSUE PERSISTED, ON OCTOBER 27, 2025, A HEALTHCARE PROVIDER (HCP) PRESCRIBED ALPRAZOLAM TO IMPROVE THE PATIENT'S TOLERANCE TO OPTUNE GIO THERAPY. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR ADDITIONAL DETAILS WERE MADE; HOWEVER, NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2870271 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986427

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention ALLOPURINOL| BUPROPION HCL XL| FLUTICASONE PROPIONATE| HYDROCODONE-ACETAMINOPHEN| IMMODIUM| LEVETIRACETAM| PANTOPRAZOLE| SENNA| SERTRALINE HCL| TEMOZOLOMIDE