BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19915103 · Received August 6, 2024

    Report

    Report Number
    3010457505-2024-00308
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 6, 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: PRIOR DEXAMETHASONE USE (IMPAIRED WOUND HEALING AND INCREASED RISK OF INFECTION ARE LISTED AS SIDE EFFECTS. SOURCE: DEXAMETHASONE PRESCRIBING INFORMATION), CONCOMITANT LOMUSTINE (CARRIES A BLACK BOX WARNING FOR MYELOSUPPRESSION. SOURCE: LOMUSTINE 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).

    Description of Event or Problem · 0

    A 40-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM), STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. DURING REVIEW OF AN AVAILABLE MEDICAL RECORD, RECEIVED BY NOVOCURE ON (B)(6) 2024, IT WAS DISCOVERED THAT IN THE BEGINNING OF (B)(6) 2024, THE PATIENT HAD SURGERY DUE TO A WOUND HEALING DISORDER. POST-OPERATIVELY THE PATIENT RECEIVED ANTIBIOTICS (TRIMETHOPRIM/SULFAMETHOXAZOLE). ON (B)(6) 2024, NOVOCURE WAS INFORMED THAT DURING AN ARRAY CHANGE, EXPOSED CRANIAL HARDWARE (SCREW) WAS OBSERVED ON THE PATIENT´S SCALP WHICH RESULTED IN THE PATIENT BEING HOSPITALIZED FROM (B)(6) 2024. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, DURING A FOLLOW-UP VISIT WITH NEUROSURGERY, THE PATIENT'S SURGICAL WOUND WAS ASSESSED AS SUFFICIENTLY HEALED. ON (B)(6) 2024, THE PATIENT RESUMED OPTUNE GIO THERAPY. 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
    1675559 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention DEXAMETHASONE| ESLICARBAZEPINE ACETATE| LACOSAMIDE| LEVOTHYROXINE| LOMUSTINE| PANTOPRAZOLE| RAMIPRIL