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 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that while a contribution of device use to the headache cannot be ruled out the events were likely due to underlying disease and gbm progression.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 also a common symptom of disease in gbm.

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2019.On december 04, 2019, novocure was informed by the spouse that the patient had been hospitalized on an unspecified date a few weeks prior due to brain edema with associated confusion, decreased appetite, and vomiting.Optune therapy was discontinued.Per prescribing physician, patient had been hospitalized for headaches and treated with steroid medication.On an unspecified date, patient was discharged to an acute care facility.The prescriber stated that the cause of the events was a combination of treatment effect, gbm progression, and optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer (Section G): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801
• MDR Report Key: 9528656
• MDR Text Key: 174461700
• Report Number: 3009453079-2019-00131
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2019

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: 43 MO
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 84