MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number	TFH-9000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	02/27/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• MDR Report Key: 5630509
• Report Number: 3009453079-2016-00070
• Device Sequence Number: 506613
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Weight: 68