MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9100

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

Patient Problem Headache (1880)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of device use to the event cannot be ruled out.Migraine was not reported as an adverse event in the (b)(6) trial in recurrent gbm.There has been 1 other report of migraine in the commercial program to date.Headaches were reported on the pivotal (b)(6) trial as an adverse event in both arms of the trial (16% optune therapy and 10% chemotherapy arm).They were attributable to the device in 3% of cases and to chemotherapy in 2% of cases.Headache is a common symptom of disease in gbm.

Event Description

Patient is a (b)(6) male with recurrent glioblastoma who began optune therapy on (b)(6) 2017.On (b)(6) 2017, spouse reported patient was brought to the hospital the night before and had discontinued device use.On november 14, 2017, spouse provided additional information regarding the cause of the hospitalization.According to the spouse, the patient had been brought to the hospital for a suspected seizure, but was subsequently diagnosed with a complex migraine and sequelae of a previous stroke (no further information provided).Physician was contacted for additional information and on january 11, 2017, he reported that prior to the hospitalization, the patient had experienced visual changes followed by progressive worsening headache, worsening right sided weakness, worsening expressive aphasia, and worsening concentration over the course of several hours.Mri was negative for disease progression.Patient was treated with headache management including iv pain medications.Out of concern for seizure, levetiracetam dose was increased.Symptoms improved with headache management therefore it was felt this was more likely a migrainous phenomenon and patient was started on migraine prophylaxis.Levetiracetam was reduced to the previous dose with further improvement in neurologic symptoms.On an unknown date, patient was discharged and subsequently entered hospice due to disease progression.Optune therapy was not restarted.Physician attributed the symptoms to underlying disease progression; however, he was unable to say if optune had any role in triggering the migraine component to the patient's presentation.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• MDR Report Key: 7263351
• MDR Text Key: 99799556
• Report Number: 3009453079-2018-00093
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 MO
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEVACIZUMAB; DEXAMETHASONE; ENOXAPARIN; LEVETIRACETAM; LISINOPRIL; LOMUSTINE; VENLAFAXINE; ZOLPIDEM; BEVACIZUMAB; DEXAMETHASONE; ENOXAPARIN; LEVETIRACETAM; LISINOPRIL; LOMUSTINE; VENLAFAXINE; ZOLPIDEM
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 113