BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19758207 · Received July 17, 2024

    Report

    Report Number
    3010457505-2024-00299
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 17, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF THE ARRAYS TO THE HEAD INJURY CANNOT BE RULED OUT. THE FALL WAS UNRELATED TO DEVICE USE. HEAD INJURY 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 71-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. DURING A REVIEW OF A MEDICAL RECORD, RECEIVED BY NOVOCURE ON (B)(6) 2024, IT WAS DISCOVERED THAT THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT (ED) ON (B)(6) 2024, AFTER A FALL WITH SECONDARY HEAD TRAUMA. THE PATIENT WAS FOUND ON THE FLOOR IN A POOL OF BLOOD, WITH PULLED OFF ARRAYS NEXT TO HIM. THE PATIENT NOTED THAT HE WAS BENDING OVER AND LOST HIS BALANCE. HE DENIED DIZZINESS OR SYNCOPE. AT THE ED A HEAD CT WAS PERFORMED WITH NO ACUTE FINDINGS. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721581 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other ACETAMINOPHEN| BACLOFEN| BEVACIZUMAB| DEXAMETHASONE| DOXYCYCLINE| FUROSEMIDE| LACOSAMIDE| LOSARTAN| MELATONIN| METFORMIN| OMEPRAZOLE MAGNESIUM| ONDANSETRON| POTASSIUM CHLORIDE| QUETIAPINE| SENNOSIDES DOCUSATE SODIUM| TEMOZOLOMIDE