MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH9100

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

Patient Problem Convulsion/Seizure (4406)

Event Date 08/24/2020

Event Type  Injury  

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 area 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 Description

A (b)(6) year old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.Per medical record review, on (b)(6) 2020, patient was being treated for increased intracranial pressure with steroids (dexamethasone, 1 mg bid).At this time, steroid taper was begun with dexamethasone discontinued on (b)(6) 2020.On (b)(6) 2020, the patient experienced a grand mal seizure and was transported to the local emergency department.Patient's anti-seizure medication was increased and dexamethasone was restarted.Patient had a history of seizures and was taking anti-seizure medication at the time of the event.On (b)(6) 2020, head mri did not show gbm progression.Eeg showed no ongoing seizures.Per the prescribing physician, the cause of the seizure was likely due to underlying gbm and less likely due to optune.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer (Section G): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 6033191907
• MDR Report Key: 10590043
• MDR Text Key: 208791558
• Report Number: 3009453079-2020-00158
• Device Sequence Number: 1
• Product Code: NZK
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2020

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 121