BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 23197554 · Received October 2, 2025

    Report

    Report Number
    3010457505-2025-00588
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 2, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A RISK FACTOR FOR SKIN INFLAMMATION/IRRITATION IN THIS PATIENT INCLUDES CONCOMITANT DOCETAXEL (HYPERSENSITIVITY REACTIONS, AND OTHER DERMATOLOGICAL ISSUES SUCH AS RASHES, ERYTHEMA, AND SKIN TOXICITIES ARE LISTED AMONG THE MOST COMMON ADVERSE REACTIONS SOURCE: DOCETAXEL PRESCRIBING INFORMATION). 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). MEDICAL DEVICE SITE HYPERHIDROSIS IS RELATED TO DEVICE USE, ALTHOUGH ASSESSED AS NON-SERIOUS.

    Description of Event or Problem · 0

    A 75-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 SPOUSE REPORTED TO NOVOCURE, THAT THE PATIENT HAD DEVELOPED A SKIN REACTION DESCRIBED AS EXTREME ITCHING AND RED RASH AFTER RECENTLY STARTING OPTUNE LUA THERAPY. THE SPOUSE HAD BEEN CHANGING THE ARRAYS DAILY, ALLOWING THE SKIN TO BREATHE, AND APPLIED CORTISONE CREAM; HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE SIGNIFICANT DISCOMFORT. ON (B)(6) 2025, THE PATIENT NOTED THAT HE HAD A HISTORY OF ADHESIVE SENSITIVITY, INCLUDING RASH AND ITCHING. ADDITIONALLY, THE PATIENT HAD BEEN TAKING CETIRIZINE DAILY SINCE THE START OF OPTUNE LUA THERAPY. THE HEALTHCARE PROVIDER (HCP) PRESCRIBED AN UNSPECIFIED TOPICAL STEROID AND RECOMMENDED TEMPORARILY DISCONTINUING OPTUNE LUA THERAPY. THE PATIENT WAS INSTRUCTED TO APPLY THE TOPICAL OINTMENT DAILY, AND TO RESUME THERAPY IF THE SYMPTOMS IMPROVED. ON (B)(6) 2025, THE PATIENT REPORTED THAT THE SKIN REACTION WAS MORE PRONOUNCED IN THE EVENING, PARTICULARLY DURING SLEEP. FURTHERMORE, THE PATIENT EXPERIENCED EPISODES OF COLD SWEATS AND FREQUENT SWEATING, WHICH THE SPOUSE ATTRIBUTED TO THE COMBINATION OF OPTUNE LUA THERAPY AND DOCETAXEL. ON (B)(6) 2025, THE SPOUSE REPORTED THAT THE PATIENT WAS CONTINUING TO CHANGE THE ARRAYS DAILY DUE TO ADHESION ISSUES. THE PATIENT WAS ALSO TAKING ORAL PREDNISONE, WHICH PROVIDED PARTIAL RELIEF OF THE ITCHING, ALTHOUGH IT DID NOT COMPLETELY RESOLVE THE ISSUE. THE PATIENT RESUMED THERAPY ON (B)(6) 2025. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN, ALTHOUGH NO REPLY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434988 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention CARVEDILOL.| CITALOPRAM HYDROBROMIDE.| CYANOCOBALAMIN.| DOCETAXEL.| FOLIC ACID.| LORAZEPAM.| ONDANSETRON.| PARACETAMOL.| SENNA.| TRIAZOLAM.