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	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of optune gio therapy to the headache cannot be ruled out.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.
Event or Problem Description
A 57-year-old female with newly diagnosed glioblastoma (gbm), started optune gio on (b)(6) 2026.On (b)(6) 2026, novocure received a medical record indicating that the patient experienced ongoing headaches, which predated the initiation of optune gio therapy.During an appointment on (b)(6) 2026, it was noted that the patient was taking sumatriptan daily with slight benefit.By (b)(6) 2026, treatment with rimegepant and bevacizumab had been initiated, resulting in improvement, and the headaches had significantly improved by (b)(6) 2026.On (b)(6) 2026, the patient reported only minimal headaches.During a follow-up visit on (b)(6) 2026, the headaches were noted to be improved and were typically associated with optune gio use.The patient used rimegepant approximately once weekly to manage the symptoms.Multiple attempts were made to contact the prescribing physician; however, no reply was received.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; 2077527602
• MDR Report Key: 25576691
• Report Number: 3010457505-2026-00771
• Device Sequence Number: 13016889
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)260107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female