BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19937812 · Received August 8, 2024

    Report

    Report Number
    3010457505-2024-00319
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 8, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF DEVICE USE TO THE TEMPORARY IMPAIRMENT OF THE SHOULDER DUE TO ROTATOR CUFF SYNDROME CANNOT BE RULED OUT. ROTATOR CUFF SYNDROME IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND 1% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 55-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2023. ON JULY 30, 2024, NOVOCURE WAS INFORMED THAT THE PATIENT WAS ENDING OPTUNE GIO THERAPY DUE TO THE WEIGHT OF THE DEVICE AND THE HEAT. THE PATIENT REPORTED THAT SHE HAD TORN HER ROTATOR CUFF FROM CARRYING THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 06, 2024, THAT THE PATIENT DID NOT REQUIRE SURGERY AS IT WAS A PARTIAL TEAR, ALTHOUGH SHE REQUIRED PHYSICAL THERAPY. THE PATIENT DISCONTINUED OPTUNE GIO THERAPY ON (B)(6) 2024. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFORMATION WITH NO REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395181 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other ALPRAZOLAM.| D-MANNOSE.| DOCUSATE SODIUM.| ESTRADIOL ACETATE.| HYDROXYZINE.| LEVETIRACETAM.| LORAZEPAM.| LUTEIN.| MELATONIN.| METFORMIN.| ONDANSETRON.| PANTOPRAZOLE SODIUM.| PHENAZOPYRIDINE.| SPIRONOLACTONE.| TEMOZOLOMIDE.| VENLAFAXINE.