MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH9000

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

Patient Problem Seizures (2063)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that the event is unrelated to optune therapy.Seizures are a known complication of gbm and during the course of the disease, 51% of patients will experience seizures (clin neurol neurosurg.2015; 139:166-171).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

(b)(6) male with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2016.On november 30, 2016 prescribing physician reported that the patient had experienced a new onset seizure and had subsequently discontinued therapy.The patient did not have a history of seizures, but had experienced olfactory and auditory hallucinations prior to initial gbm resection ((b)(6) 2016).Patient was put on levetiracetam and steroids (unspecified) and has not had any further seizures.Physician was unable to establish an underlying cause for the event and therefore could not rule out any association 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: 6218525
• MDR Text Key: 63735776
• Report Number: 3009453079-2017-00079
• Device Sequence Number: 1
• Product Code: NZK
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TFH9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2016
• Device Age: 6 MO
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• 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: DEXAMETHASONE; FAMOTIDINE; LEVETIRACETAM; OXYCODONE; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR