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 09/25/2015

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician that the seizures were related to underlying anaplastic astrocytoma.Seizures were not related to optune.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 (anaplastic astrocytoma).

Event Description

Patient with newly diagnosed anaplastic astrocytoma began optune therapy on (b)(6), 2015.On (b)(6), 2015, novocure was informed that on (b)(6), 2015 the patient had been hospitalized due to new onset seizure.The patient had experienced three six minute seizures without return to baseline prior to presentation.Mri did not show any new areas of enhancement or increased perfusion signal, compared to previous (on (b)(6) 2015).Anti-seizure medication (levetiracetam) was increased however, the patient had two additional seizures on (b)(6), 2015.The patient was loaded with phenytoin but developed a drug reaction (itching) and was switched to lacosamide.The patient did not experience further seizures during the hospital stay but remained tired and significantly weaker than before the seizures.Weakness was attributed to seizures and steroid (dexamethasone) myopathy.Seizure precautions were continued during the hospital stay.At the time of the report, the patient was still hospitalized with plans to discharge home with occupational therapy and physical therapy for ongoing weakness.Per the prescribing physician, the seizures were related to disease progression and were not related to optune therapy.

• 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: 5205296
• MDR Text Key: 30548726
• Report Number: 3009453079-2015-00062
• 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: 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 Model Number: TFH-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 3 YR
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2012
• 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: ENOXAPARIN SODIUM
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 69