MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9100

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

Patient Problem Seizures (2063)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy.The patient had a history of seizures and was on anticonvulsants.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 (b)(6) patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017.On (b)(6) 2018, novocure was informed that the patient had been hospitalized on (b)(6) 2018, following a seizure.When contacted for additional information, the prescribing physician reported that the patient had previously experienced a new onset seizure in (b)(6) 2017 and had been treated with levetiracetam and valproic acid.The prescriber did not provide any additional details on the (b)(6) hospitalization.On (b)(6) 2018, the prescriber noted that the patient had reported to him that "she occasionally forgets how to turn off and on the device while plugging it to be charged and she use the wrong buttons which results in [a].Malfunction".The prescriber stated that this may be responsible for increasing her seizures while already on anti-seizure medication.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• MDR Report Key: 7283408
• MDR Text Key: 100470853
• Report Number: 3009453079-2018-00091
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 02/20/2018

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: TFH-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 19 MO
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2016
• 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: LEVETIRACETAM; LITHIUM CARBONATE; RISPERIDONE; VALPROIC ACID
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 89