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 10/17/2017

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 (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial ((b)(6) in optune/tmz and tmz arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Additional risk factors for seizure in this patient include: concomitant temozolomide [convulsions are listed as among the most common adverse reactions.Source: temozolomide prescribing information] and concomitant dexamethasone [convulsion is listed as a known adverse reaction.Source: dexamethasone prescribing information].Seizures are a known complication of the underlying disease (gbm).

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017.On october 19, 2017, novocure was informed that the patient had been hospitalized on (b)(6) 2017, due to new onset seizure.Per hospital summary, patient presented to the emergency room with walking difficulties and numbness in the right leg and arm.In the er, the patient developed slurred speech and confusion.Optune therapy was temporarily discontinued upon hospital admission.The patient was started on intravenous anti-seizure medication (levetiracetam 500 mg bid).Eeg demonstrated epileptic activity in the left parietal region.Ct scan was negative for tumor progression.On (b)(6) 2017, the patient was discharged home with outpatient care.The patient resumed optune therapy after a 4 day treatment break with no further seizure activity reported.The prescribing physician could not rule out that optune therapy contributed to the event.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa 31905
• Manufacturer (Section G): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa 31905 ; 9724850120
• MDR Report Key: 7082828
• MDR Text Key: 93725514
• Report Number: 3009453079-2017-00089
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/05/2017

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 10 MO
• Event Location: Home
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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: DEXAMETHASONE; PANTOPRAZOLE; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR