BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19803163 · Received July 23, 2024

    Report

    Report Number
    3010457505-2024-00305
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 23, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE IMPAIRED HEALING OF THE WOUND COMPLICATION CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR IMPAIRED HEALING IN THIS PATIENT INCLUDE PRIOR LOMUSTINE (CARRIES A BLACK BOX WARNING FOR MYELOSUPPRESSION. SOURCE: LOMUSTINE PRESCRIBING INFORMATION), PRIOR DEXAMETHASONE USE (IMPAIRED WOUND HEALING AND INCREASED RISK OF INFECTION ARE LISTED AS SIDE EFFECTS. SOURCE: DEXAMETHASONE PRESCRIBING INFORMATION), PRIOR RADIATION, CHEMOTHERAPY, PRIOR SURGERY AFFECTING THE SKIN INTEGRITY AND UNDERLYING GBM DISEASE. IMPAIRED HEALING 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 47-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON MAY 06, 2024, THAT THE PATIENT EXPERIENCED A WOUND COMPLICATION DESCRIBED AS TWO AREAS IN THE REGION OF THE SURGICAL RESECTION SCAR THAT WERE PAINFUL AND RED. IN ADDITION, THE PATIENT NOTED THAT SHE WAS GOING TO BE ADMITTED TO THE HOSPITAL ON (B)(6) 2024, DUE TO AN MRI CHANGE AND SUSPECTED TUMOR RECURRENCE. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, THE PATIENT'S SPOUSE REPORTED, THE PATIENT REMAINED HOSPITALIZED, AND HER GENERAL CONDITION HAD DECLINED. THE PATIENT'S SPOUSE INFORMED NOVOCURE ON (B)(6) 2024, THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024, AFTER EXPERIENCING A WOUND HEALING DISORDER ASSOCIATED WITH POST OPERATIVE COMPLICATIONS FOLLOWING RECURRENCE SURGERY. REPORTEDLY, THE PATIENT HAD RECOVERED WELL IN THE PAST FEW WEEKS. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483742 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other DEXAMETHASONE.