MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	11/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy.Risk factors for seizure in this patient include: concomitant temozolomide (convulsions are listed as among the most common adverse reactions.Source: temozolomide prescribing information).Seizures were reported as adverse events in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (22% and 21% in optune/tmz and tmz arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of gbm and have been reported as the presentation symptom in 27% of cases.During the course of the disease, 51% of patients will experience seizures (clin neurol neurosurg.2015; 139:166-171).
Event or Problem Description
A 68-year old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2022.Novocure received a report on (b)(6) 2022, that the patient experienced a seizure on (b)(6) 2022, that required hospitalization.Optune therapy was temporarily discontinued.The patient presented with altered mental status and unable to confirm medical history.The patient was administered intravenous (iv) anti-seizure medication (lacosamide 200 mg, levetiracetam 2,000 mg).Continuous electroencephalography (eeg) confirmed abnormal findings consistent with seizure activity.On (b)(6) 2022, the prescribing physician reported the patient did not have a history of seizures.The brain mri did not show evidence of disease progression and eeg showed abnormal activity confirming seizure.Reportedly, the patient was discharged home in stable condition and prescribed levetiracetam.The physician noted the patient was prescribed temozolomide and unsure if the seizure was related to optune therapy or temozolomide.

• Brand Name: OPTUNE
• Common Device Name: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 15932571
• Report Number: 3010457505-2022-00222
• Device Sequence Number: 20466945
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; ONDANSETRON; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG