MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problem Seizures (2063)

Event Date 02/27/2016

Event Type  Injury  

Manufacturer Narrative

Patient with newly diagnosed glioblastoma experienced new onset seizure resulting in hospital admission while on optune therapy.Novocure medical opinion is that the seizure was related to the underlying diagnosis of glioblastoma, and was not related to optune.Seizure occurred approximately 1 month after the start of optune therapy.Patient continued with optune therapy after a 5 day treatment hiatus with no further seizure activity reported.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 (16% and 18% 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 the underlying disease (gbm).Additional risk factors for seizure in this patient include: concomitant bevacizumab [seizure was among the most common bevacizumab-related toxicities in phase ii-iii studies, affecting 9-9.7% of patients.Source: lai et al., jco, 2011, 29(2): 1420148 / chinot et al., neuro-onc, 2012, 14 (suppl 6): vi101-105], 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].

Event Description

Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2016.On (b)(6) 2016 novocure was informed that the patient had been hospitalized (b)(6) 2016 due to a new onset seizure.Optune therapy was temporarily discontinued during this time period.On (b)(6) 2016 the prescribing physician confirmed that the patient had presented with tumor progression and was not on anticonvulsants at the time of the seizure.No additional information was provided.Physician stated that the seizure was probably related to underlying disease, however a relationship with optune therapy could not be ruled out.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5630509
• MDR Text Key: 44371251
• Report Number: 3009453079-2016-00070
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• 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: 05/03/2016

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-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/13/2016
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 68