BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 25254642 · Received May 22, 2026

    Report

    Report Number
    3010457505-2026-00738
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 22, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034/S033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE¿S MEDICAL OPINION IS THAT THE POSSIBILITY THAT CARRYING THE OPTUNE GIO DEVICE MAY HAVE CONTRIBUTED TO THE BACK PAIN CANNOT BE RULED OUT. BACK PAIN WAS REPORTED WITH OPTUNE GIO DEVICE USE IN EF-11 AND EF-14 TRIALS (EF-11 2% AND 10% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 62-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT'S CAREGIVER INFORMED NOVOCURE THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR REHABILITATION DUE TO RECURRING BACK PAIN. ON (B)(6) 2026, IT WAS NOTED THAT THE BACK PAIN WAS EXACERBATED BY OPTUNE GIO DEVICE USE. THE BACK PAIN WAS REPORTED TO HAVE BEEN PRESENT PRIOR TO INITIATION OF OPTUNE GIO THERAPY. THE PATIENT REMAINED ON OPTUNE GIO THERAPY. ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO RESPONSE WAS RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475645 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 N/A 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1