BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 24636750 · Received March 19, 2026

    Report

    Report Number
    3010457505-2026-00706
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 17, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983129
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THIS EVENT IS UNRELATED TO OPTUNE LUA THERAPY AND IS RELATED TO UNDERLYING DISEASE (NSCLC). AS THE PHYSICIAN WAS UNABLE TO RULE OUT A POSSIBLE CONTRIBUTION OF OPTUNE LUA THERAPY TO THE EVENT, NOVOCURE IS REPORTING OUT OF AN ABUNDANCE OF CAUTION. DYSKINESIA WAS NOT REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC. DYSKINESIA HAS NOT BEEN REPORTED IN THE OPTUNE LUA COMMERCIAL PROGRAM TO DATE.

    Description of Event or Problem · 0

    A 79-YEAR-OLD MALE WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED WEAKNESS ON THE LEFT SIDE INCLUDING THE ARM, HAND, AND LEG IMMEDIATELY FOLLOWING THE REMOVAL OF THE TRANSDUCER ARRAYS FROM THE TORSO. ON (B)(6) 2026, THE SPOUSE DESCRIBED THE PATIENT'S SYMPTOMS AS IT APPEARED THAT HE HAD NO CONTROL OF HIS MOVEMENTS, WHICH LASTED APPROXIMATELY 30 MINUTES. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) WHERE HE WAS MONITORED OVERNIGHT. DURING THE HOSPITALIZATION, THE PATIENT UNDERWENT DIAGNOSTIC TESTING INCLUDING A MAGNETIC RESONANCE IMAGING (MRI) SCAN, WHICH SHOWED NO EVIDENCE OF A CEREBROVASCULAR ACCIDENT OR OTHER ACUTE FINDINGS. THE ER PHYSICIAN INDICATED THAT THE EVENT MAY HAVE BEEN RELATED TO DEVICE USE. ON (B)(6) 2026, THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO INVOLUNTARY ARM MOVEMENTS AND TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY. AT THAT TIME, THE PATIENT DID NOT EXPERIENCE DISEASE PROGRESSION. THE PHYSICIAN ASSESSED THAT THE EVENT WAS LIKELY CAUSED BY OPTUNE LUA THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71752 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983129

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization ASPIRIN.| CALCIUM.| CEPHALEXIN.| DENOSUMAB.| EYE VITAMIN.| GABAPENTIN.| MULTIVITAMIN.| PREDNISONE.| SIMVASTATIN.