BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19946728 · Received August 9, 2024

    Report

    Report Number
    3010457505-2024-00320
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 9, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF THE TRANSDUCER ARRAYS TO THE SKIN LACERATION CANNOT BE RULED OUT. THE FALL , EYE CONTUSION, SYNCOPE AND POSITIONAL DIZZINESS WERE UNRELATED TO DEVICE USE. SKIN LACERATION 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 72-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON (B)(6) 2024, THAT THE PATIENT EXPERIENCED A BAD FALL THE NIGHT BEFORE AND WAS GOING TO DEFER MEDICAL INTERVENTION. THE IMAGE PROVIDED INDICATED THE TRANSDUCER ARRAYS WERE ON THE SCALP AT THE TIME OF THE HEAD INJURY. IN ADDITION, THERE APPEARED TO BE A SKIN LACERATION ON THE TOP OF THE HEAD AND LEFT EYE CONTUSION. PER THE EMERGENCY DEPARTMENT (ED) REPORT PROVIDED BY THE PRESCRIBING PHYSICIAN, THE PATIENT PRESENTED ON (B)(6) 2024, FOLLOWING A SYNCOPAL EPISODE TWO DAYS PRIOR. THE EPISODE RESULTED IN A FALL AND INJURY TO THE HEAD (SKIN LACERATION/SKIN ABRASION) AND FACE (LEFT EYE CONTUSION). REPORTEDLY, THE PATIENT HAD MULTIPLE SYNCOPAL EPISODES VERSUS SEIZURES LATELY. SHE HAD A HISTORY OF SEIZURE ALTHOUGH HAD NOT BEEN TAKING THE PRESCRIBED MEDICATION (LEVETIRACETAM). THE NEUROLOGIST CONSULT BELIEVED THAT THE SYNCOPAL EPISODES WERE NOT DUE TO NEUROLOGICAL PROBLEMS. CT HEAD WAS PERFORMED WITH NO ACUTE FINDINGS. THE CARDIOLOGIST PRESCRIBED THE PATIENT AN ANTIARRHYTHMIC (DRONEDARONE) AND DUE TO POSITIONAL DIZZINESS, MECLIZINE AS NEEDED. THE PRESCRIBING PHYSICIAN REPORTED ON (B)(6) 2024, THE EVENT WAS DUE TO CARDIAC CAUSES, UNRELATED TO OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662491 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other ACETYLSALICYLIC ACID| DEXAMETHASONE| DRONEDARONE| ERGOCALCIFEROL| HYDROCODONE-ACETAMINOPHEN| MECLIZINE| METOPROLOL SUCCINATE| ONDANSETRON| SULFAMETHOXAZOLE/TRIMETHOPRIM| TEMOZOLOMIDE