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 07/08/2022

Event Type  Injury  

Event Description

A 58 year old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2022.On july 09, 2022, novocure received a report that on the way home after beginning treatment, the patient experienced a seizure and was hospitalized on the same day.Optune therapy was temporarily discontinued.On (b)(6) 2022, the prescribing physician reported the patient did not have a prior history of seizure or epilepsy and was not taking any anti-seizure medications.Treatment included hydrate sodium fosphenytoin and perampanel hydrate.It was reported on august 30, 2022, the patient discontinued optune therapy on (b)(6) 2022, due to disease progression.The prescribing physician could not rule out a contribution to optune therapy due to the short time span between the start of treatment and the seizure.

Manufacturer Narrative

Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy.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: 15378641
• MDR Text Key: 299455571
• Report Number: 3010457505-2022-00215
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• 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: TFH9100JP
• Device Lot Number: N/A
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT PROVIDED
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male