BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 20491288 · Received October 21, 2024

    Report

    Report Number
    3010457505-2024-00357
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    October 5, 2024
    Report Date
    October 21, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE OPTUNE GIO DEVICE TO THE PATIENT'S TEMPORARY IMPAIRMENT SECONDARY TO THE VERTEBRAL FRACTURE CANNOT BE RULED OUT. THE FALL WAS UNRELATED TO OPTUNE GIO. SPINAL 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 (B)(4) REPORTS OF SPINAL FRACTURES IN THE COMMERCIAL PROGRAM TO DATE. TWO OF WHICH WERE RELATED TO DEVICE USE.

    Description of Event or Problem · 0

    A 47-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT HAD FALLEN FROM A FULL HEIGHT ONTO THEIR BACK ON THE OPTUNE GIO DEVICE ON (B)(6) 2024, RESULTING IN A FRACTURE OF THE LUMBAR VERTEBRA (L1). THE TREATMENT PLAN INCLUDED WEARING A CORSET, AND NO SURGERY WAS REQUIRED. THE PATIENT IS CURRENTLY CONTINUING WITH OPTUNE GIO THERAPY. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930713 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention NOT PROVIDED.