BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19758333 · Received July 17, 2024

    Report

    Report Number
    3010457505-2024-00300
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 17, 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 DEHISCENCE CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR WOUND DEHISCENCE IN THIS PATIENT INCLUDE: CONCOMITANT BEVACIZUMAB (VEGF INHIBITOR WHICH CARRIES A BLACK BOX WARNING FOR WOUND HEALING COMPLICATIONS, SOURCE BEVACIZUMAB PRESCRIBING INFORMATION), PRIOR DEXAMETHASONE USE (IMPAIRED WOUND HEALING AND INCREASED RISK OF INFECTION ARE LISTED AS SIDE EFFECTS. SOURCE: DEXAMETHASONE PRESCRIBING INFORMATION), PRIOR RADIATION, UNDERLYING CANCER DISEASE AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND DEHISCENCE IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND <1% EF-14 OPTUNE ARM). ADDITIONAL NOTE: MANUFACTURING DATE FOR TFH212787 IS NOVEMBER 18, 2020.

    Description of Event or Problem · 0

    A 58-YEAR-OLD FEMALE PATIENT WITH RECURRENT GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2018. ON JUNE 20, 2024, NOVOCURE WAS INFORMED THAT ON AN UNSPECIFIED DATE THE PATIENT HAD SURGERY FOR REMOVAL OF CRANIAL HARDWARE (SCREW) WHICH WAS THREATENING TO PIERCE HER SCALP. REPORTEDLY, THE SURGERY WAS ALSO LIKELY DUE TO GBM RECURRENCE. THE PRESCRIBING PHYSICIAN WAS CONTACTED ALTHOUGH WAS UNABLE TO PROVIDE FURTHER DETAILS OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503536 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention APIXABAN.| CHOLECALCIFEROL.| IBUPROFEN.| LACOSAMIDE.| LEVETIRACETAM.| METAMIZOLE SODIUM.| PANTOPRAZOLE.