BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 23828816 · Received December 17, 2025

    Report

    Report Number
    3010457505-2025-00639
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 5, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983075
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 29, 2026, NOVOCURE IDENTIFIED THAT THE INITIAL REPORT HAD BEEN SUBMITTED WITH AN INCORRECT CATALOG NUMBER AND PRODUCT CODE. THE CORRECT CATALOG NUMBER FOR DEVICE TFT01704 IS TFT9201EU, AND THE CORRECT PRODUCT CODE IS SDA.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, NOVOCURE MEDICAL OPINION IS THAT THE EVENT OF HEMATOMA WAS RELATED TO OPTUNE LUA. THE EVENTS OF THORACIC PAIN, HEMOPTYSIS, SEIZURE AND PNEUMONIA WERE MOST LIKELY RELATED TO THE PATIENT'S UNDERLYING DISEASE (NSCLC) AND NOT RELATED TO OPTUNE LUA THERAPY. HEMATOMA WAS NOT REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC. THERE HAVE BEEN NO PRIOR REPORTS OF HEMATOMA IN THE OPTUNE LUA NSCLC COMMERCIAL PROGRAM. CHEST PAIN WAS REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (2% OVERALL IN THE TTFIELDS ARMS AND 0% OVERALL IN THE CONTROL ARMS). HEMOPTYSIS WAS REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (7% OVERALL IN THE TTFIELDS ARMS AND 8% OVERALL IN THE CONTROL ARMS). SEIZURE HAS BEEN REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (<1% OVERALL IN THE TTFIELDS ARMS AND 0% OVERALL IN THE CONTROL ARMS). PNEUMONIA WAS REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (14% OVERALL IN THE TTFIELDS ARMS AND 15% OVERALL IN THE CONTROL ARMS).

    Description of Event or Problem · 0

    A 65-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S PHYSICIAN REPORTED TO NOVOCURE THAT THE PATIENT HAD BEEN HOSPITALIZED AND HAD EXPERIENCED HEMATOMAS AT THE OPTUNE LUA TRANSDUCER ARRAY SITE. ON (B)(6) 2025, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED A SEIZURE THE PREVIOUS DAY AND WAS ADMITTED TO THE HOSPITAL, WHERE PNEUMONIA WAS DIAGNOSED. ON (B)(6) 2025, THE PHYSICIAN REPORTED THE PATIENT WAS HOSPITALIZED FOR THORACIC PAIN AND BLOODY COUGH. SUSPECTING THERAPEUTIC INTOLERANCE, OPTUNE LUA THERAPY WAS DISCONTINUED. THE PHYSICIAN COULD NOT EXCLUDE A POTENTIAL CONTRIBUTION OF OPTUNE LUA TO THE HEMATOMAS, THORACIC PAIN AND BLOODY COUGH. THE PATIENT HAD REPORTEDLY NOT PREVIOUSLY RECEIVED AN IMMUNE CHECKPOINT INHIBITOR BUT WAS RECEIVING ONE AT THE TIME OF THE REPORT. THE PATIENT HAD BEEN THROUGH MANY CHEMOTHERAPY CYCLES PRIOR TO STARTING OPTUNE LUA THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181378 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983075

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization MOXIFLOXACIN