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 06/30/2022

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizure was related to tumor progression and possible radiation effect 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).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

Novocure received a report that the patient had been hospitalized on (b)(6) 2022, due to a seizure.Optune therapy was temporarily discontinued.The patient experienced an acute onset of seizure like activity with right sided weakness.The patient's family called emergency medical services and upon arrival, the patient experienced another 30 second episode of flaccidity on the right side with incoherent speech and postictal phase.The patient did not have a history of seizures and was admitted for observation.The patient's neuro-oncologist recommended initiation of anti-seizure medication (levetiracetam 500 mg bid).The patient had no further seizure like activity while hospitalized.On (b)(6) 2022, the patient was discharged home.Per the prescribing physician, the cause of the event was most likely due to radiation effect versus tumor progression.He additionally stated, he could not entirely exclude a contribution of optune to the event.

• 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: 15114651
• MDR Text Key: 296709902
• Report Number: 3010457505-2022-00214
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: TFH9100US
• Device Lot Number: N/A
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2016
• 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
• Treatment: ATORVASTATIN; CITALOPRAM; CLOBETASOL TOPICAL SPRAY; CYCLOBENZAPRINE; FAMOTIDINE; LORAZEPAM; LOSARTAN; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female