MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problem Convulsion, Tonic (2223)

Event Date 03/06/2015

Event Type  Injury  

Event Description

Patient with recurrent glioblastoma began optune therapy on (b)(6) 2015.On (b)(6) 2015 novocure was informed that the patient had experienced a seizure and was hospitalized.Per hospital summary, the patient presented to the emergency department on (b)(6) 2015 after developing weakness of the upper extremity along with slurred speech.Ct scan showed no evidence of hemorrhage, mass effect or midline shift and no change in pre-existing edema pattern in the left hemisphere.Patient had a history of seizures and was taking anti-seizure medication (levetiracetam) at the time of the event.Patient was initially treated with lorazepam and levetiracetam dose was increased from 750mg am, 1000mg pm to 1000mg twice a day but patient subsequently developed another episode of slurred speech and right-hand weakness.Patient was then placed on levetiracetam 1500mg twice a day with no additional seizure episodes.Per hospital summary, symptoms were most likely due to seizure activity and subsequent postictal state due to vasogenic edema around the glioblastoma.On (b)(6) 2015, patient was discharged in stable condition.At the time of the report, it was unknown if the patient has restarted optune therapy.Per the prescribing physician, the events were caused by underlying gbm but a possible contribution of optune therapy could not be ruled out.

Manufacturer Narrative

Novocure opinion is that the events were related to underlying gmb and were not related to optune therapy.Seizures were reported as adverse events on the (b)(4) trial in both arms of the trial (9% and 4% in optune therapy and chemotherapy arms respectively).None of these seizures were considered seizures are a known complication of the underlying disease (recurrent gbm).

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg. sha'ar hacarmel 4th floor; haifa ; IS ; 48501204
• MDR Report Key: 4679621
• MDR Text Key: 5627171
• Report Number: 3009453079-2015-00052
• Device Sequence Number: 1
• Product Code: NZK
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2015

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
• Other Device ID Number: 07290107980401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: PYRIDOXINE; RANITIDINE; RIVAROXABAN; VITAMIN B12; GLYCOL
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR