MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Convulsion/Seizure (4406)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizure was unrelated to optune therapy and related to the underlying disease.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 Description

A 62-year-old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2023.Novocure was informed on (b)(6) 2023, that the patient experienced an unwitnessed fall, was unconscious and subsequently hospitalized the same day.The prescribing physician reported on (b)(6) 2023, that the patient was brought by ambulance to the hospital following a first epileptic seizure on (b)(6) 2023.Cranial ct was performed which showed no clear evidence of a recent demarcating infarct or a recent intracerebral hemorrhage.Electroencephalogram (eeg) showed local abnormal signs on the right frontocentral side, but no clear diffuse cerebral dysfunction and no signs of increased excitability.During the hospitalization, levetiracetam 500mg was initiated twice daily.The patient remained hospitalized for observation until (b)(6) 2023.A brain mri was scheduled for (b)(6) 2023, to evaluate for disease progression.The prescribing physician could not exclude a connection to optune therapy to the event, although assessed it was unlikely.

• Brand Name: OPTUNE GIO
• Type of Device: OPTUNE GIO
• 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: 18533084
• MDR Text Key: 333087633
• Report Number: 3010457505-2023-00246
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: TFH9100EU
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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: CANDESARTAN; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female