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	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the seizure was related to the underlying disease 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) and concomitant dexamethasone (convulsion is listed as a known adverse reaction.Source: dexamethasone prescribing information).Seizures were reported as adverse events on the pivotal phase iii recurrent gbm trial in both arms of the trial (9% and 4% in optune therapy and chemotherapy 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 40-year-old male with a high grade glioma started optune therapy on (b)(6) 2023.Novocure was informed on (b)(6) 2023, that the patient was hospitalized earlier that day due to a seizure.The patient noted he had discontinued an unspecified seizure medication the month prior.The patient's health care provider (hcp) was made aware and optune therapy was temporarily discontinued.On (b)(6) 2023, the hcp reported that the patient did not have a history of seizure.In addition, levetiracetam was previously prescribed during his hospital admission in (b)(6) 2023.In the emergency department (ed) following the seizure the patient was administered intravenous (iv) levetiracetam 1 gram and upon hospital admission 500mg iv every 12 hours.Lorazepam was prescribed as needed for breakthrough seizures.The patient was discharged on (b)(6) 2023, on oral levetiracetam 500mg bid, and advised to resume dexamethasone and follow up with radiation oncology and neurosurgery.The hcp assessed that the exact cause of the event was unknown, the event may or may not have involved underlying disease and/or optune therapy.

• 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: 17445552
• Report Number: 3010457505-2023-00242
• Device Sequence Number: 19504692
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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: 07/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2016
• 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: DEXAMETHASONE; FAMOTIDINE; LEVETIRACETAM; METHOCARBAMOL; OXYCODONE-ACETAMINOPHEN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 95 KG