BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIOI

    MDR report key: 22033449 · Received May 16, 2025

    Report

    Report Number
    3010457505-2025-00508
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 16, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CEREBROVASCULAR ACCIDENT WAS UNRELATED TO OPTUNE GIO THERAPY AND RELATED TO THE UNDERLYING DISEASE. CEREBROVASCULAR ACCIDENT 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 59-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2025. ON APRIL 23, 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR A STROKE ON (B)(6) 2025, REPORTEDLY WHILE UNDERGOING OPTUNE GIO THERAPY. ON MAY 2, 2025, THE PRESCRIBING PHYSICIAN PROVIDED ADDITIONAL DETAILS, STATING THAT ALTHOUGH THE CORRELATION TO THE EVENT IS NOT MEDICALLY EVALUABLE, A LINK BETWEEN THE STROKE AND THE OPTUNE GIO DEVICE CANNOT BE EXCLUDED DUE TO THE TIMING OF THE EVENT. AS A RESULT, OPTUNE GIO THERAPY WAS PERMANENTLY DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909127 OPTUNE GIOI OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention NOT PROVIDED.