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, Focal (2260)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the events were related to underlying gbm and were not related 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) and concomitant dexamethasone (convulsion is listed as a known adverse reaction.Source: dexamethasone 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 (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).

Event Description

Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015 the caregiver reported that the patient had temporarily discontinued optune therapy for approximately a month prior due to new onset seizures and had been admitted to a rehabilitation facility.The patient presented to the emergency room on (b)(6) 2015 with focal status epilepticus clinically.Patient was admitted to the icu.Eeg confirmed significant right hemisphere status epilepticus.The patient was intubated and started on intravenous levetiracetam bolus as well as fosphenytoin and lacosamide.Brain mri showed substantial improvement in the right hemispheric tumor with much less enhancement, mass effect and edema compared to previous (performed on (b)(6) 2015).On (b)(6) 2015, eeg was abnormal, suggesting severe encephalopathy possibly due to medical effect.Left temporal sharp waves placed patient at risk for focal secondary generalized seizures.On (b)(6) 2015, eeg was grossly abnormal with diffuse slow background suggestive of severe encephalopathy.On (b)(6) 2015 prolonged video eeg was abnormal with slow background and frequent right temporal sharp waves indicative of severe encephalopathy.Fifteen (15) minutes of subclinical focal status resolved during the recording.On an unknown date, the patient was discharged to a rehabilitation facility and planned to restart optune therapy.

• 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: 5302141
• MDR Text Key: 33659776
• Report Number: 3009453079-2015-00067
• 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: 11/30/2015

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
• Device Age: 36 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 103