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	Medical device site infection (4845)
Date of Event	07/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 35-year-old male patient with diffuse midline glioma began optune gio therapy on (b)(6) 2024.On (b)(6) 2025, novocure was notified that the patient temporarily discontinued optune gio therapy due to a shunt infection that necessitated surgical removal.The caregiver believed that the infection was unrelated to device use.During an in-home visit on (b)(6) 2025, it was noted that the patient had a large ventriculoperitoneal shunt, which was placed on (b)(6) 2023, on the top-left side of the head, and the arrays were placed to avoid the area.On (b)(6) 2025, further information was provided indicating that the patient still had sutures in place on the scalp following the surgery.As a result, optune gio therapy could not be resumed until the scalp fully healed.The prescribing physician was contacted for further details, although no reply was received.
Additional Manufacturer Narrative
Novocure's medical opinion is that the contribution of the transducer array placement to the shunt infection that required surgical intervention cannot be ruled out.Shunt infection was not reported as an expected event with optune gio device use in the (ef-11 or ef-14 trial in optune arm).There have been 5 reports of shunt infection in the commercial program to date.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer (Section G): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 22826305
• Report Number: 3010457505-2025-00566
• Device Sequence Number: 4577591
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)201229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; CLINDAMYCIN TOPICAL; DIPHENHYDRAMINE; EPINEPHRINE; LACOSAMIDE; MEMANTINE; MEPERIDINE; MIRTAZAPINE; MULTIVITAMIN; PEMBROLIZUMAB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 66 KG