BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19010030 · Received April 1, 2024

    Report

    Report Number
    3010457505-2024-00266
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    October 19, 2023
    Report Date
    April 1, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107982238
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE OPTUNE GIO DEVICE TO THE FALL AND SECONDARY HUMERUS FRACTURE CANNOT BE RULED OUT. FALL IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 4% AND 8% EF-14 OPTUNE ARM). HUMERUS FRACTURE WAS NOT REPORTED AS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE IN THE (EF-11 OR EF-14 TRIAL IN OPTUNE ARM). THERE HAVE BEEN APPROXIMATELY 4 REPORTS OF HUMERUS FRACTURE IN THE COMMERCIAL PROGRAM TO DATE.

    Description of Event or Problem · 0

    A 68-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT A FEW DAYS PRIOR, WHILE THE PATIENT WAS CARRYING THE OPTUNE GIO DEVICE ON HIS BACK HE LOST HIS BALANCE AND FELL. THE PATIENT WAS BROUGHT TO THE HOSPITAL WHERE AN X-RAY CONFIRMED A HUMERUS FRACTURE. ON (B)(6) 2023, THE ATTENDING PHYSICIAN REPORTED THAT A CAUSAL RELATIONSHIP BETWEEN THE FALL AND THE LOSS OF BALANCE DUE TO THE WEIGHT OF THE OPTUNE GIO DEVICE WAS POSSIBLE, ALTHOUGH THE INJURY DID NOT RESULT IN HOSPITALIZATION AND DEEMED NON-SERIOUS. THE PHYSICIAN NOTED THE PATIENT DID NOT EXPERIENCE DIZZINESS OR LIGHT-HEADEDNESS AND WAS PRESCRIBED NO CONCOMITANT MEDICATIONS THAT WOULD CONTRIBUTE TO THE EVENT. THE PATIENT ENDED OPTUNE GIO THERAPY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767107 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107982238

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| O NOT PROVIDED.