BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 20075562 · Received August 27, 2024

    Report

    Report Number
    3010457505-2024-00326
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 6, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION NOVOCURE CANNOT RULE OUT THAT OPTUNE GIO USE CONTRIBUTED TO THE EVENT. USING OPTUNE GIO THERAPY TOGETHER WITH ACTIVE IMPLANTED MEDICAL DEVICES IS CONTRAINDICATED. THIS IS A KNOWN CONTRAINDICATION WHICH IS INCLUDED IN OPTUNE GIO'S LABELING. NO CHANGE TO BENEFIT/RISK PROFILE OF THE DEVICE. TTFIELDS TOGETHER WITH ACTIVE IMPLANTABLE MEDICAL DEVICES WAS NOT TESTED IN THE PIVOTAL EF-11 AND EF-14 TRIALS. IN THE COMMERCIAL PROGRAM TO DATE THERE WERE NO SIMILAR REPORTS OF OPTUNE GIO THERAPY INTERFERING WITH A PACEMAKER.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, NOVOCURE DISCOVERED THAT THE PATIENT'S DATE OF BIRTH IN THE INITIALLY SUBMITTED MEDICAL DEVICE REPORT (MDR) WAS INCORRECT. THE CORRECT DATE OF BIRTH IS (B)(6)1939.

    Description of Event or Problem · 0

    AN (B)(6) MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6), 2024. ON JULY 30, 2024, NOVOCURE WAS INFORMED BY A HEALTH CARE PROVIDER, THAT THE OPTUNE GIO THERAPY WAS LIKELY INTERFERING WITH THE PATIENT'S PACEMAKER. THE PATIENT WAS USING MEDTRONIC MICRA AV2 PACEMAKER FOR INTERMITTENT CHB. ACCORDING TO THE REPORT, PATIENT WAS MEETING WITH A MEDTRONIC REPRESENTATIVE FOR INTERROGATION OF THE PACEMAKER. THEY WERE HAVING DIFFICULTIES INTERROGATING THE DEVICE BECAUSE OF INTERFERENCE WITH THE OPTUNE GIO DEVICE, ONLY AFTER TURNING OFF OPTUNE GIO THERAPY, THE TECHNICIAN COULD PERFORM THE INTERROGATION. ACCORDING TO THE REPORT RECEIVED BY NOVOCURE, THE MEDTRONIC TECHNICAL SUPPORT MENTIONED, THAT THERE IS A POTENTIAL FOR OVERSENSING WITH OPTUNE GIO USE. THE REPORTER NOTED THAT THE PATIENT SUFFERS FROM ALZHEIMER'S AND HAS TROUBLE REPORTING SYMPTOMS, HOWEVER, THE PATIENT'S WIFE MENTIONED TO THE REPORTER, HE HAS BEEN TIRED AND FATIGUED, BUT SHE HAS NOT OBSERVED SYNCOPE OR NEAR SYNCOPE. IN ADDITION, ON JULY 31, 2024, THE PATIENT'S SPOUSE REPORTED TO NOVOCURE, THAT THE CARDIOLOGIST DID LET THEM KNOW, THAT THE OPTUNE GIO DEVICE WAS "STOPPING" THE PACEMAKER AND HE INSTRUCTED THEM TO DISCONTINUE OPTUNE GIO THERAPY. THE PATIENT DISCONTINUED OPTUNE GIO THERAPY ON (B)(6) 2024. THE PRESCRIBING PHYSICIAN WAS CONTACTED, BUT HAD NOT SEEN THE PATIENT AND COULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953760 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other ACETAMINOPHEN| DEXAMETHASONE| DONEPEZIL| FAMOTIDINE| LOSARTAN| MEDTRONIC MICRA¿ AV2 PACEMAKER| ONDANSETRON| SIMVASTATIN| TAMSULOSIN| TEMOZOLOMIDE