BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 7979755 · Received October 18, 2018

    Report

    Report Number
    3009453079-2018-00108
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 11, 2018
    Report Date
    January 7, 2022
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 23, 2021, NOVOCURE DISCOVERED THAT THE INITIAL SUBMITTED MEDICAL DEVICE REPORT HAD A TYPO IN THE MODEL NUMBER FOR THE OPTUNE DEVICE IN SECTION D4-SUSPECT MEDICAL DEVICE MODEL NUMBER. CORRECTED MODEL NUMBER IS TFH9100.

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR IF THE CLINICAL SYMPTOMS IN THIS PATIENT WERE DUE TO TREATMENT EFFECT (I.E., RADIONECROSIS), PSEUDOPROGRESSION OR TRUE TUMOR PROGRESSION. DIAGNOSIS IS DIFFICULT WITHOUT A BIOPSY WITH HISTOPATHOLOGY OR TIME. FOLLOWING RADIOTHERAPY, CHANGES ON CONVENTIONAL MRI INCLUDING INCREASED PERILESIONAL EDEMA AND WORSENED ENHANCEMENT MAY REPRESENT TUMOR PROGRESSION OR RESPONSE TO RADIATION. APPROXIMATELY 50% OF PATIENTS WILL EXPERIENCE IMAGING CHANGES CONNOTING TUMOR PROGRESSION WITHIN 1 MONTH OF RADIATION THERAPY OF WHICH 50% ARE LIKELY TO HAVE PSEUDOPROGRESSION RATHER THAN PROGRESSIVE DISEASE. RADIONECROSIS TYPICALLY IS REPORTED WITHIN 3-12 MONTHS FOLLOWING RADIATION TREATMENT, WITH INCIDENCE RANGING FROM 5-40% OF PATIENTS (ELLINGSON ET AL., J NEUROONCOL 134 (3): 495-504, 2017). AS THESE EVENTS OCCURRED APPROXIMATELY 4 MONTHS AFTER THE COMPLETION OF THIS PATIENT'S RADIATION TREATMENT, THEY FALL WITHIN THE REPORTED TIMEFRAMES FOR EITHER PSEUDOPROGRESSION (3-6 MONTHS) OR RADIATION NECROSIS. CLINICAL SYMPTOMS OF ACUTE RADIATION INJURY ARE SIGNS OF INCREASED INTRACRANIAL PRESSURE WITH PROGRESSIVE FOCAL DEFECTS WHICH ARE TYPICALLY TRANSIENT AND REVERSIBLE. STEROIDS USUALLY ALLEVIATE CLINICAL SIGNS AND SYMPTOMS, AS SEEN IN THIS PATIENT. NOVOCURE OPINION IS THAT IT IS POSSIBLE THAT THE CLINICAL SYMPTOMS WERE DUE TO A COMBINED TREATMENT EFFECT OF RADIATION PLUS OPTUNE. RADIATION NECROSIS WAS REPORTED IN THE (B)(6) TRIAL OF OPTUNE TOGETHER WITH TEMOZOLOMIDE (TMZ) COMPARED TO TMZ ALONE IN PATIENTS WITH NEWLY DIAGNOSED GBM IN THE TMZ ARM OF THE STUDY ONLY (1%). IN THE COMMERCIAL PROGRAM, THERE HAVE BEEN (B)(4) PRIOR REPORTS OF RADIATION NECROSIS, ALL OF WHICH WERE NON-SERIOUS AND ASSESSED AS NOT RELATED TO OPTUNE THERAPY.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED. PER HOSPITAL SUMMARY, THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2018 WITH WORSENING CONFUSION, PROGRESSIVE HEADACHES AND GAIT IMBALANCE OF 3-4 DAYS DURATION. BRAIN MRI SHOWED POSSIBLE DISEASE PROGRESSION AND VASOGENIC EDEMA. PATIENT WAS GIVEN 10MG INTRAVENOUS DEXAMETHASONE AND ADMITTED TO THE NEURO INTENSIVE CARE UNIT FOR MONITORING AND FURTHER ASSESSMENT. THE TUMOR BOARD CONCLUDED THE CAUSE OF THE EVENT WAS TREATMENT EFFECT RATHER THAN RECURRENCE AND RECOMMENDED CONTINUATION OF DEXAMETHASONE PLUS TEMOZOLOMIDE AND OPTUNE. PATIENT WAS DISCHARGED HOME IN IMPROVED CONDITION ON (B)(6) 2018 AND STARTED ON DEXAMETHASONE 4MG BID. AT THE TIME OF THE REPORT, THE PATIENT HAD RESUMED OPTUNE THERAPY. PER THE PRESCRIBER, THE CAUSE OF THE EVENTS LEADING TO ADMISSION WAS TREATMENT EFFECT, POSSIBLY A COMBINATION OF RADIATION AND OPTUNE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820809 OPTUNE OPTUNE NZK NOVOCURE GMBH TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization ACETAMINOPHEN.| LORAZEPAM.| OMEPRAZOLE.| ONDANSETRON.| SENOKOT.| TEMOZOLOMIDE.| ACETAMINOPHEN| LORAZEPAM| OMEPRAZOLE| ONDANSETRON| SENOKOT| TEMOZOLOMIDE