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 (2063)

Event Date 09/07/2015

Event Type  Injury  

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 in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (16% and 18% in optune/tmz and tmz arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of the underlying disease (gbm).

Event Description

Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015, novocure was informed that on approximately (b)(6) 2015, the patient had been hospitalized due to new onset seizure.The patient was unsure of what happened prior to admission and "woke up" after a few days in the hospital.Optune was temporarily discontinued upon admission.The patient was started on unspecified anti-seizure medication.No further details on the hospitalization were available.Patient improved with no further seizure activity.Patient was discharged approximately two weeks later and resumed optune therapy.Prescribing physician stated that the event was caused by edema from pseudo-progression and was unrelated to optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5159112
• MDR Text Key: 28584812
• Report Number: 3009453079-2015-00061
• 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
• Report Date: 09/29/2015

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 Expiration Date: 07/09/2014
• Device Model Number: TFH-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 1 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• 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: BLOOD PRESSURE MED (UNKNOWN)
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 77