MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH-9100

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

Patient Problem Headache (1880)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of device use to the event cannot be ruled out.Other contributing factors in this patient include: concomitant temozolomide (headache is listed as a common adverse event.Source: temozolomide prescribing information) and underlying disease (tumor progression reported in month prior to event).Headaches were reported on 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 (28% and 20% in optune/tmz and tmz arms respectively).Headache is a common symptom of disease in gbm.

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017.On (b)(6) 2018, the patient reported that he had been hospitalized for one night due to headache experienced while using optune therapy.No further information was provided.The prescribing physician was contacted for additional information with no response.

Manufacturer Narrative

Novocure agrees with the prescribing physician that the events were not related to optune therapy and were related to tumor progression.

Event Description

On (b)(6) 2018, the prescribing physician provided further information.On (b)(6) 2018, the patient presented to the emergency room with a three day history of headache, vomiting and decreased appetite.He did not show any other clinical or neurological deficits.Head ct scan was negative for tumor progression, hydrocephalus, or intracranial hemorrhage.After administration of dexamethasone and ondansetron, the symptoms improved significantly and upon patient's request he was discharged home on (b)(6) 2018.On (b)(6) 2018, patient was hospitalized again with headache and loss of appetite.Symptoms improved with dexamethasone and the patient was discharged home in good general condition on (b)(6) 2018.Head mri on (b)(6) 2018, showed significant tumor progression.The patient was admitted to the hospital on (b)(6) 2018, and surgical resection was performed on (b)(6) 2018.Patient was discharged home on (b)(6) 2018, in good general condition and without headache.Per the prescribing physician, the events 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, 31905 ; IS 31905
• MDR Report Key: 7473924
• MDR Text Key: 106929837
• Report Number: 3009453079-2018-00100
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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: 9 MO
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVETIRACETAM; METAMIZOLE; ONDANSETRON; OXYCODONE HYDROCHLORIDE; PANTOPRAZOLE; TEMOZOLOMIDE; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR