BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 21476299 · Received February 27, 2025

    Report

    Report Number
    3010457505-2025-00456
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    September 3, 2024
    Report Date
    February 27, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 UNDERLYING DISEASE AS THE PATIENT WAS EXPERIENCING DISEASE PROGRESSION. THE DEATH WAS UNRELATED TO OPTUNE GIO USE. 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 60-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2024, AS PART OF THE NON-INTERVENTIONAL STUDY "USE OF TTFIELDS IN FRANCE IN ROUTINE CLINICAL CARE STUDY PROGRAM - DAILY ACTIVITY, SLEEP AND NEUROCOGNITIVE FUNCTIONING IN NEWLY DIAGNOSED GLIOBLASTOMA PATIENTS STUDY" (TIGER FRANCE). ON (B)(6) 2024, NOVOCURE RECEIVED A SERIOUS ADVERSE EVENT (SAE) REPORT MENTIONING THAT ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED DUE TO A RIGHT-SIDED ISCHEMIC STROKE. DURING HOSPITALIZATION, THE PATIENT WAS STARTED ON METHYLPREDNISOLONE. CRANIAL CT WAS PERFORMED ON (B)(6) 2024 AND SHOWED PROGRESSIVE DISEASE. AS A RESULT, THE PATIENT PERMANENTLY DISCONTINUED OPTUNE GIO THERAPY. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. THE INVESTIGATORS ASSESSED THE EVENT AS POSSIBLY RELATED TO OPTUNE GIO USE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2025, FOLLOWING NEUROLOGICAL DETERIORATION AND GENERAL HEALTH DETERIORATION. THOSE EVENTS WERE ASSESSED AS NOT RELATED TO OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699105 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention NOT PROVIDED.