BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 24994945 · Received April 27, 2026

    Report

    Report Number
    3010457505-2026-00721
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 27, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE TRANSDUCER ARRAYS PLACEMENT TO THE SKIN INFLAMMATION/IRRITATION, CANNOT BE RULED OUT. HYPERHIDROSIS IS RELATED TO DEVICE USE, ALTHOUGH ASSESSED AS NON-SERIOUS. SKIN REACTION HAS BEEN REPORTED IN THE PIVOTAL EF- 24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (19% OVERALL IN THE TTFIELDS ARMS AND 2% OVERALL IN THE CONTROL ARMS).

    Description of Event or Problem · 0

    A 76-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6), 2025. ON (B)(6), 2026, NOVOCURE WAS INFORMED THAT THE PATIENT HAD EXPERIENCED A RECURRENCE OF SKIN IRRITATION AND WAS TREATED WITH PREDNISONE. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING EXCESSIVE SWEATING, WHICH LED TO THE ARRAYS PEELING OFF THE TORSO. ACCORDING TO THE AVAILABLE MEDICAL RECORD DATED FEBRUARY 06, 2026, THE PATIENT HAD PREVIOUSLY DISCONTINUED PREDNISONE 5MG IN (B)(6) 2026. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302448 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention CERVEDILOL| CITALOPRAM HYDROBROMIDE| FENTANYL PATCH| FOLIC ACID| HYDROCORTISONE| LORAZEPAM| ONDANSETRON| PROBIOTIC| SENNA| TRIAZOLAM