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, Grand-Mal (2168)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the event was related to underlying gbm and was 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 on the pivotal phase 3 recurrent gbm trial in both arms of the trial (9% and 4% respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of the underlying disease (recurrent gbm).

Event Description

Patient with recurrent glioblastoma began optune therapy on (b)(6) 2015.On (b)(6) 2015, novocure was informed by the patient's spouse that the patient had been hospitalized following a seizure.On (b)(6) 2015 the prescribing physician confirmed that on (b)(6) 2015, the patient had been found by a family member with new onset generalized convulsive activity which lasted 2-3 minutes and resolved.Patient was admitted to the hospital on (b)(6) 2015 and started on levetiracetam.Optune therapy was discontinued on admission.Patient was discharged (b)(6) 2015.No further information was provided.It is unknown if the patient restarted optune therapy.The patient did not have a history of seizures and was not on anti-seizure medication at the time of the event.

• 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: 5307796
• MDR Text Key: 33825602
• Report Number: 3009453079-2015-00068
• 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: 2 YR
• Event Location: Home
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 91