BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 22824998 · Received August 18, 2025

    Report

    Report Number
    3010457505-2025-00567
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 18, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT A CONTRIBUTION OF THE TRANSDUCER ARRAYS TO THE SKIN INFLAMMATION/IRRITATION THAT REQUIRED MEDICAL INTERVENTION CANNOT BE RULED OUT. FATIGUE AND NIGHT SWEATS WERE RELATED TO THE USE OF DEVICE, ALTHOUGH NOT SERIOUS. PYREXIA WAS UNRELATED TO THE USE OF THE DEVICE. 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 62-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING MINOR SKIN IRRITATION LOCALIZED TO THE LEFT SIDE OF THE TORSO. SUBSEQUENTLY, DURING A HOME VISIT ON (B)(6) 2025, WITH THE PATIENT AND THE PATIENT'S CAREGIVERS, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED A FEVER, SEVERE RASH AND WORSENING SKIN IRRITATION DURING THE PRIOR WEEK. THESE SYMPTOMS WERE SUSPECTED TO BE ASSOCIATED WITH THE INITIATION OF CHEMOTHERAPY ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED A 10-DAY COURSE OF TRIMETHOPRIM/SULFAMETHOXAZOLE, ALONG WITH NYSTATIN AND A TOPICAL NUMBING CREAM. IT WAS ALSO REPORTED THAT THE TRANSDUCER ARRAYS WERE COMING OFF THE TORSO DURING EPISODES OF NIGHT SWEATS. ONE PHOTO WAS PROVIDED, DEPICTING THE PATIENT'S FRONT TORSO. THE IMAGE REVEALED ROUND, PAPULAR LIKE LESIONS WITH MODERATE SURROUNDING ERYTHEMA. TWO LESIONS WERE OBSERVED ON THE LEFT BREAST, ONE ON THE MID-LEFT ABDOMINAL QUADRANT, AND TWO LOCATED ADJACENT TO THE UMBILICUS. ADDITIONALLY, MILD SCATTERED ERYTHEMA WAS NOTED THROUGHOUT THE TORSO. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT THE PATIENT EXPERIENCED NIGHT SWEATS AND FATIGUE RELATED TO OPTUNE LUA THERAPY. THE PATIENT WAS PRESCRIBED LIDOCAINE/PRILOCAINE CREAM FOR ACCESS DISCOMFORT, HYDROCORTISONE CREAM FOR RASH AND TRIMETHOPRIM/SULFAMETHOXAZOLE FOR GENERALIZED RASH/BOILS. IT WAS NOTED THAT THE PATIENT WAS SUPPOSED TO COMPLETE THE ANTIBIOTIC COURSE ON (B)(6) 2025. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS ALTHOUGH NO REPLY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590352 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention DEXAMETHASONE| HYDROCODONE-ACETAMINOPHEN| LORAZEPAM| MECLIZINE| NAPROXEN| OLANZAPINE| ONDANSETRON| PROMETHAZINE| TAMSULOSIN