BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA NSCLC

    MDR report key: 25123251 · Received May 8, 2026

    Report

    Report Number
    3010457505-2026-00728
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 8, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF DEVICE USE TO THE PATIENT´S ANXIETY, REQUIRING MEDICAL INTERVENTION, CANNOT BE RULED OUT. ANXIETY HAS BEEN REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (4% OVERALL IN THE TTFIELDS ARMS AND 2% OVERALL IN THE CONTROL ARMS). CLAUSTROPHOBIC SENSATION, PANIC, HYPERVENTILATION, AND INTERMITTENT SHORTNESS OF BREATH WERE SECONDARY SYMPTOMS OF PATIENT´S ANXIETY. PRURITUS, HEAT SENSATION, HYPERHIDROSIS, AND DISCOMFORT WERE RELATED TO DEVICE USE, ALTHOUGH ASSESSED AS NON-SERIOUS.

    Description of Event or Problem · 0

    A 60-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) - ADENOCARCINOMA STARTED OPTUNE LUA THERAPY ON (B)(6) 2026. ON (B)(6) 2026, A MEDICAL RECORD WAS RECEIVED BY NOVOCURE DOCUMENTING THAT, DURING AN ONCOLOGY FOLLOW UP APPOINTMENT ON (B)(6) 2026, THE PATIENT HAD DIFFICULTY TOLERATING OPTUNE LUA THERAPY, PARTICULARLY OVERNIGHT. THE PATIENT REPORTED SIGNIFICANT PRURITUS, HEAT, SWEATING, AND SEVERE DISCOMFORT WHILE SLEEPING WITH THE TRANSDUCER ARRAYS IN PLACE. THE PATIENT WAS ABLE TO TOLERATE DEVICE USE BETTER DURING DAYTIME HOURS. THE PATIENT ALSO REPORTED SENSATIONS OF EXPERIENCING CLAUSTROPHOBIA, PANIC, HYPERVENTILATION, AND INTERMITTENT SHORTNESS OF BREATH WHEN WEARING THE DEVICE. THE SPOUSE OBSERVED THAT THE PATIENT'S ANXIETY INCREASED DUE TO CONCERNS THAT THE INABILITY TO WEAR THE DEVICE COULD ADVERSELY AFFECT HIS PROGNOSIS. THE PHYSICIAN PRESCRIBED LORAZEPAM TO MANAGE THE PATIENT'S ANXIETY RELATED TO NIGHTTIME DEVICE INTOLERANCE. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN WITH NO REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54376 OPTUNE LUA NSCLC OPTUNE LUA SDA NOVOCURE GMBH TFT9200 N/A 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1