BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 22325864 · Received June 25, 2025

    Report

    Report Number
    3010457505-2025-00527
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    June 1, 2025
    Report Date
    October 17, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE WOUND INFECTION CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR WOUND INFECTION IN THIS PATIENT INCLUDE: UNDERLYING CANCER DISEASE AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND INFECTION IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND <1% EF-14 OPTUNE ARM). SEIZURE AND CEREBRAL HEMORRHAGE ARE RELATED TO THE UNDERLYING DISEASE AND NOT RELATED TO OPTUNE GIO USE. FURTHERMORE, OPTUNE GIO IS INDICATED FOR USE IN ADULT PATIENTS OF 18 YEARS AND OLDER ONLY. IN THIS CASE, THE DEVICE WAS USED IN A PEDIATRIC PATIENT.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, NOVOCURE RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT HAS BEEN HOSPITALIZED SINCE (B)(6) 2025 AND UNDERWENT ANOTHER SURGERY DUE TO WOUND HEALING DISORDER. OPTUNE GIO HAS BEEN TEMPORARILY DISCONTINUED SINCE THEN.

    Description of Event or Problem · 0

    A 15-YEAR-OLD MALE PATIENT WITH HIGH GRADE GLIOMA (HGG), STARTED OPTUNE GIO THERAPY ON (B)(6) 2022. ON JUNE 2, 2025, THE PATIENT'S FATHER INFORMED NOVOCURE THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2025, DUE TO NEUROLOGICAL SYMPTOMS. AS A RESULT, OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED, AND DIAGNOSTIC SCANS WERE PLANNED. ON JUNE 3, 2025, THE PATIENT'S HEALTHCARE PROVIDER REPORTED THAT A HEAD MRI REVEALED BLEEDING IN THE RESECTION CAVITY. THE BLEEDING WAS SUBSEQUENTLY DRAINED, AND THE PATIENT RECEIVED TREATMENT FOR A WOUND INFECTION. ON JUNE 5, 2025, THE TREATING PHYSICIAN PROVIDED AN UPDATE STATING THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE WOUND INFECTION, WHICH INCLUDED EVACUATION OF PUS, REMOVAL OF THE HEMORRHAGE FROM THE RESECTION CAVITY, AND DISINFECTION OF A BONE FRAGMENT. THE PHYSICIAN CONSIDERED THE POST-OPERATIVE WOUND INFECTION TO BE POSSIBLY RELATED TO MULTIPLE PRIOR RESECTIONS (LAST SURGICAL RESECTION ON (B)(6) 2025) AND IMMUNOTHERAPY BUT ASSESSED OPTUNE GIO THERAPY ITSELF AS AN UNLIKELY CAUSE. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEGUN AN INDIVIDUAL HEALING ATTEMPT INVOLVING A PEPTIDE VACCINE AND NIVOLUMAB. SINCE STARTING NIVOLUMAB, THE PATIENT EXPERIENCED EPISODES OF REDUCED LIMB FUNCTION ON ONE SIDE FOLLOWED BY MYOCLONIA, RESEMBLING ATAXIA. ON (B)(6) 2025, THE PATIENT'S FATHER NOTIFIED NOVOCURE THAT THE PATIENT HAD BEEN DISCHARGED HOME EARLIER THAT DAY. OPTUNE GIO THERAPY BREAK WILL CONTINUE UNTIL THE WOUND HAS FULLY HEALED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A SEIZURE ON (B)(6) 2025, ALONG WITH EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941444 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Required Intervention NOT PROVIDED.