BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 22780297 · Received August 12, 2025

    Report

    Report Number
    3010457505-2025-00561
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 12, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986427
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE WEIGHT OF CARRYING THE OPTUNE GIO DEVICE MAY HAVE CONTRIBUTED TO THE LOWER BACK PAIN. BACK PAIN IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 2% AND 10% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 49-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING SEVERE LOWER BACK PAIN AND NOTED THAT WEARING THE OPTUNE GIO DEVICE APPEARED TO BE CONTRIBUTING TO HER SYMPTOMS. AS A RESULT, SHE HAD BEEN UNDERGOING PHYSICAL THERAPY. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, ALTHOUGH NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270420 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986427

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention BUPRENORPHINE TRANSDERMAL PATCH| LORAZEPAM| ONDANSETRON| PROCHLORPERAZINE