MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE; NZK

Model Number TFH-9000

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

Patient Problem Convulsion, Tonic (2223)

Event Date 02/23/2015

Event Type  Injury  

Event Description

Patient with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015, the patient was hospitalized due to new onset seizure.Prior to admission, patient had experienced a 20 minute episode of confusion and visual disturbance.Patient was admitted for neurological work-up and mri scan (results not provided).Optune therapy was temporarily discontinued upon admission.Ophthalmologic consultation found left lower homonymous quadrantanopia with no papilledema.Brain ct scan did not show evidence of disease progression.Patient was treated with levetiracetam 500 mg bid and dexamethasone dose was increased to 6 mg daily.Patient improved with no further seizure activity.Patient was discharged on (b)(6) 2015 and optune therapy was restarted.Per the prescribing physician, the events were the results of an epileptiform attack related to the patient's underlying gbm.

Manufacturer Narrative

Novocure agrees with the prescribing physician that the seizure was related to underlying gbm.Seizure was not related to optune.Patient continued with optune therapy with no further seizure activity reported.Seizures were reported as adverse events on the pivotal phase iii recurrent gbm trial in both arms of the trial (9% and 4% in optune therapy and chemotherapy arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of the underlying disease (recurrent gbm).

• Brand Name: OPTUNE
• Type of Device: NZK
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg. matam center; 4th floor; haifa ; IS ; 4851204
• MDR Report Key: 4739540
• MDR Text Key: 5890016
• Report Number: 3009453079-2015-00054
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 03/31/2015

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: 03/31/2015
• Initial Date FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR