BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19738025 · Received July 15, 2024

    Report

    Report Number
    3010457505-2024-00297
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 15, 2024
    Manufacturer
    NOVOCURE, INC.
    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 A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE WOUND INFECTION CANNOT BE RULED OUT. THE SEIZURE WAS UNRELATED TO DEVICE USE. CONTRIBUTING FACTORS FOR WOUND INFECTION IN THIS PATIENT INCLUDE: RADIATION, CHEMOTHERAPY AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND INFECTION 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 64-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2024, NOVOCURE WAS INFORMED THAT WHEN THE ARRAYS WERE REMOVED AN UNSPECIFIED FLUID LEAKAGE WAS OBSERVED THAT THE SPOUSE SUSPECTED WAS COMING FROM THE SURGICAL RESECTION SITE ON THE RIGHT SIDE OF THE PATIENT´S HEAD. REPORTEDLY, THE PATIENT WENT TO THE HOSPITAL AND WAS PRESCRIBED UNSPECIFIED ANTIBIOTICS. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. THE PATIENT'S SPOUSE REPORTED ON (B)(6) 2024, THAT THE PATIENT HAD A SEIZURE THAT MORNING, WHICH IMPROVED WHEN PRESCRIBED ANTI-SEIZURE MEDICATION (LEVETIRACETAM). ON (B)(6) 2024, NOVOCURE WAS INFORMED THAT THE PATIENT WAS HOSPITALIZED SINCE (B)(6) 2024, FOR REMOVAL OF THE SKULL BONE DUE TO THE SPREAD OF INFECTION. POST-OPERATIVELY THE PATIENT RECEIVED UNSPECIFIED ANTIBIOTIC TREATMENT. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392185 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H ACETYLSALICYLIC ACID| AMLODIPINE| ATORVASTATIN| CANDESARTAN| HYDROCHLOROTHIAZIDE| LEVETIRACETAM| METOPROLOL SUCCINATE| PANTOPRAZOLE| TEMOZOLOMIDE