BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19835961 · Received July 26, 2024

    Report

    Report Number
    3010457505-2024-00307
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 29, 2024
    Report Date
    August 8, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAYS TO THE SKIN LACERATION CANNOT BE RULED OUT. THE FALL WAS UNRELATED TO DEVICE USE. SKIN LACERATION IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND 1% EF-14 OPTUNE ARM).

    Additional Manufacturer Narrative · 0

    DURING REVIEW OF AN AVAILABLE MEDICAL RECORD RECEIVED BY NOVOCURE ON (B)(6) 2024, IT WAS DISCOVERED DURING A FOLLOW-UP VISIT ON (B)(6) 2024, THE PATIENT HAD RESUMED OPTUNE GIO THERAPY ON (B)(6) 2024, WITHOUT ANY COMPLICATIONS. IN ADDITION, THE SURGERY FOR IMPLANTATION OF A PACEMAKER HAD BEEN POSTPONED TO THE END OF (B)(6) 2024.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM), STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON JULY 01, 2024, THAT THE PATIENT FELL ON (B)(6) 2024, AND HIT HIS HEAD THAT RESULTED IN A SMALL SKIN LACERATION, WHILE ON OPTUNE GIO THERAPY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION ON (B)(6) 2024. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED AN UNWITNESSED FALL AND DID NOT LOSE CONSCIOUSNESS. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A SEIZURE BEFORE OR AFTER THE FALL. REPORTEDLY, THE PATIENT SUSTAINED A SUPERFICIAL INJURY ON THE HEAD MOST LIKELY AROUND THE OUTER EAR AND WAS TAKEN TO THE HOSPITAL. A HEAD CT SCAN WAS PERFORMED WITH NO ACUTE FINDINGS. IN ADDITION, THE PATIENT WAS EXAMINED BY AN ENT SPECIALIST, WHO FOUND NO ISSUES REQUIRING TREATMENT. A LONG-TERM ELECTROCARDIOGRAM (ECG) SHOWED AN INDICATION FOR IMPLANTATION OF A CARDIAC PACEMAKER. THE PRESCRIBING PHYSICIAN ASSESSED THE FALL AS LIKELY RELATED TO A CARDIAC ISSUE, NOT RELATED TO OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705472 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other| H APIXABAN.| TEMZOLOMIDE.