MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Convulsion/Seizure (4406)

Event Date 11/04/2021

Event Type  Injury  

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2021.On (b)(6) 2021, the spouse reported to novocure that the patient had been hospitalized due to seizure activity.Optune therapy was temporarily discontinued.The patient had a history of seizures and was taking anti-seizure medication (lacosamide 50 mg bid).Per the hospital discharge summary, the spouse stated she heard the patient state that the optune device was shocking him and found him experiencing a tonic-clonic seizure.Emergency medical services (ems) were called and the patient was transported to the emergency department (ed) for evaluation.Ems administered a sedative (midazolam) en route and the patient received lorazepam in the ed.Temperature 97.5, pulse 85, respiratory rate 21, blood pressure 144/88, and pulse oximetry 99% on room air.The patient was admitted for seizure and started on intravenous anti-seizure loading dose (levetiracetam 3000 mg).The patient was able to follow a few simple commands but remained nonverbal.Telemetry neurology consult recommended an mri, eeg, and to increase iv anti-seizure medication (lacosamide) to 800 mg every 8 hours.Ed physician noted the seizure activity was likely triggered by "electric shock".The patient did not experience any additional seizures during the hospitalization.On (b)(6) 2021, the patient was discharged home in stable condition with instructions to continue with lacosamide 100 mg bid and follow up with physical therapy due to residual left sided weakness.Prescribing physician did not provide a causality assessment for the seizure activity.Device was returned to manufacturer and no functional issues were identified during investigation.Device powered on and passed all safety and functional tests.Device logfile review showed no errors that would indicate an electrical malfunction and no alarms related to tfh functionality.

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) and concomitant dexamethasone (convulsion is listed as a known adverse reaction.Source: dexamethasone 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).

• Brand Name: OPTUNE
• Type of Device: 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: 12883336
• MDR Text Key: 282970539
• Report Number: 3010457505-2021-00192
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ASPIRIN; DEXAMETHASONE; PANTOPRAZOLE; RAMIPRIL; TAMSULOSIN; TEMAZEPAM; TEMOZOLOMIDE; TIOTROPIUM; TIOTROPIUM BROMIDE INHALER; TRANYLCYPROMINE
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White