MAUDE Adverse Event Report: NOVOCURE GmbH Optune Gio

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 41-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2026.On (b)(6) 2026, the patient informed novocure that he had been hospitalized due to headaches.On (b)(6) 2026, a follow-up report was received indicating that the patient had temporarily discontinued optune gio therapy due to headaches, nightmares, and hallucinations.On (b)(6) 2026, the patient further confirmed that he had resumed optune gio therapy approximately one week earlier and that the treatment interruption had been due to headaches experienced while on therapy; however, the headaches had been resolved by the time of the report.Review of the available medical records revealed a medical history significant for localization-related epilepsy, mild traumatic brain injury, alcohol abuse, and headaches associated with altitude changes, all predating the initiation of optune gio therapy.The patient also reported a history of a motor vehicle accident at the age of 19, after which he experienced chronic sleep disturbances.Multiple attempts were made to contact the prescribing physician; however, no reply was received.
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of optune gio therapy to the headache cannot be ruled out.Nightmares and hallucinations were unrelated to device use.Headache is an expected event with optune gio device use (ef-11 16% and 28% ef-14 optune arm).Headache is also an expected symptom of disease in gbm.

• Brand Name: Optune Gio
• Common Device Name: Optune Gio
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50867607
• Report Number: 3010457505-2026-00871
• Device Sequence Number: 10715990
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)170120
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100034/S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male