BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 22803363 · Received August 14, 2025

    Report

    Report Number
    3010457505-2025-00563
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 14, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE ABSCESS THAT REQUIRED SURGICAL INTERVENTION CANNOT BE RULED OUT. ABSCESS IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND <1% EF-14 OPTUNE ARM). THE DEATH WAS UNRELATED TO OPTUNE GIO THERAPY AND RELATED TO THE UNDERLYING DISEASE. DEATH IS AN EXPECTED EVENT IN PATIENTS WITH GLIOBLASTOMA DUE TO THE NATURAL HISTORY OF THE DISEASE. THE PROGNOSIS OF GLIOBLASTOMA IS POOR WITH MEDIAN SURVIVAL OF 14.6 MONTHS AND 5-YEAR SURVIVAL OF 0.05% TO 4.7% (NEURO-ONCOLOGY 16:7, 896-913, 2014).

    Description of Event or Problem · 0

    A 67-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT PRESENTED WITH PERSISTENT SKIN REDNESS AND A POSSIBLE ABSCESS AT NEUROSURGERY ON (B)(6) 2025. THE SUSPECTED ABSCESS IN THE RIGHT FRONTAL SCALP AREA WAS SURGICALLY OPENED, AND THE PATIENT WAS PRESCRIBED UNSPECIFIED ANTIBIOTIC THERAPY ALONG WITH TOPICAL IODINE TREATMENT FOR ONE WEEK. REDNESS WAS ALSO OBSERVED ON THE BACK OF THE PATIENT'S HEAD. OPTUNE GIO THERAPY WAS DISCONTINUED. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS BUT DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT. ON (B)(6) 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT DIED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687052 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention NOT PROVIDED.