MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9100

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

Patient Problem Seizures, Focal (2260)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy.Seizures were reported as adverse events on the (b)(6).None of these seizures were considered device or chemotherapy related by investigators.Additional risk factors for seizure in this patient include: concomitant temozolomide (convulsions are listed as among the most common adverse reactions.Source: temozolomide prescribing information).Seizures are a known complication of the underlying disease (gbm).

Event Description

A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2017.On january 25, 2018, the spouse reported to novocure that the patient had been hospitalized due to a seizure.On (b)(6) 2018, the patient experienced generalized and right sided weakness, headache, confusion, and two episodes of tonic-clonic seizure.Generalized weakness and confusion continued after each seizure with post ictal amnesia.The following day the patient was transported and hospitalized after presenting with ongoing generalized weakness, fatigue, variable hypertension and fever.Patient temporally discontinued optune therapy during the hospital stay.Brain ct scan demonstrated no acute findings.Blood lab values showed low levels of anti-seizure medication (levetiracetam).Due to suspected encephalitis, cerebral spinal fluid culture and virus serology was ordered and came back negative.Meningitis test was negative.Ophthalmology was consulted and no papilledema was seen.Patient was started on an anti-viral medication (acyclovir), but this was discontinued after herpes test was negative.Patient was treated for seizure by increasing levetiracetam from 500 mg bid to 1000 mg tid.No additional seizure activity was reported.The patient was discharged on an unknown date.Per the prescribing physician, the patient did not have a history of seizures and the cause of the event was underlying gbm, hypertensive encephalopathy, and optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, il 31905 ; IS 31905
• MDR Report Key: 7270045
• MDR Text Key: 100049461
• Report Number: 3009453079-2018-00090
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

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: 16 MO
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• 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: LEVETIRACETAM; LEVOTHYROXINE; OMEPRAZOLE; ROSUVASTATIN; TEMOZOLOMIDE; VALSARTAN
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR