BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19317724 · Received May 15, 2024

    Report

    Report Number
    3010457505-2024-00277
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 19, 2024
    Report Date
    June 3, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION NOVOCURE CANNOT RULE OUT THAT OPTUNE GIO USE CONTRIBUTED TO THE EVENT. THE ATTEMPTED SELF-INJURY DID OCCUR DUE TO MISUSE OF THE PRODUCT. AS PER THE PRESCRIBING PHYSICIAN, PATIENT HAD PERSONALITY CHANGE, WHICH WAS PROBABLY DUE TO PROGRESSION OF DISEASE AS WELL AS OPTUNE GIO THERAPY. IN ADDITION, THE PATIENT HAD EXPERIENCED ONGOING DEPRESSION WHICH STARTED PRIOR TO OPTUNE GIO INITIATION. AN ADDITIONAL RISK FACTOR FOR PSYCHIATRIC AND NEUROLOGIC SYMPTOMS IN THIS PATIENT IS CONCOMITANT LEVETIRACETAM (CARRIES A WARNING FOR BEHAVIORAL ABNORMALITIES INCLUDING PSYCHOTIC SYMPTOMS, SUICIDAL IDEATION, IRRITABILITY, AND AGGRESSIVE BEHAVIOR). BASED ON THE REPORTED INFORMATION, THE EVENT DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE OR IN A LIFE-THREATENING SITUATION. THERE ARE NO LONG-RANGE HEALTH CONSEQUENCES TO BE EXPECTED BASED ON THE REPORTED INFORMATION. INTENTIONAL SELF-INJURY WAS NOT REPORTED WITH OPTUNE GIO DEVICE USE IN THE EF-11 OR EF-14 PIVOTAL TRIALS, OR IN THE COMMERCIAL PROGRAM TO DATE. CHANGE IN PERSONALITY ASSOCIATED WITH DEVICE USE WAS REPORTED 27 TIMES IN THE COMMERCIAL PROGRAM TO DATE. ADDITIONAL NOTE: MANUFACTURING DATE OF TFH212969 IS DECEMBER 22, 2020.

    Additional Manufacturer Narrative · 0

    NOVOCURE RECEIVED ADDITIONAL INFORMATION ON MAY 09, 2024, THAT THE PATIENT´S DEPRESSION HAD IMPROVED WITH THE ANTIDEPRESSANT PRESCRIBED BY THE HEALTHCARE PROVIDER (HCP). REPORTEDLY, THE PATIENT REMAINS ON OPTUNE GIO THERAPY.

    Description of Event or Problem · 0

    A 32-YEAR-OLD MALE PATIENT WITH RECURRENT ANAPLASTIC ASTROCYTOMA BEGAN OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2024, NOVOCURE WAS INFORMED THAT WHEN REMOVING THE ARRAYS, THE PATIENT TRIED TO HARM HIMSELF WITH THE CABLES FROM THE OPTUNE GIO DEVICE. REPORTEDLY, THE PATIENT WAS CONFUSED, AND THE CAREGIVER REDIRECTED THE PATIENT TO PREVENT HIM FROM HARM. THE PATIENT'S CAREGIVER NOTED THE PATIENT EXPERIENCED DEPRESSION SINCE DIAGNOSIS THAT HAD NOT WORSENED SINCE OPTUNE GIO START. THE PATIENT WAS RECENTLY PRESCRIBED AN UNSPECIFIED ANTIDEPRESSANT. AN AVAILABLE MEDICAL RECORD CONFIRMED THE PATIENT HAD A HISTORY OF DEPRESSION PRIOR TO OPTUNE GIO START. ON (B)(6) 2024, A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD NOT BEEN HOSPITALIZED DUE TO THE EVENT. PER THE HCP, PERSONALITY CHANGE WAS PROBABLY DUE TO PROGRESSION OF DISEASE AND POSSIBLY OPTUNE GIO THERAPY, ALTHOUGH THE PATIENT EXPERIENCED DEPRESSION AT BASELINE PRIOR TO OPTUNE GIO START.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357563 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other LEVETIRACETAM| LORAZEPAM| PHENYTOIN