MAUDE Adverse Event Report: NeuroOne Medical Technologies Corporation EVO sEEG Electrode; Depth Electrode

Model Number	NSEEG3410-RF
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that on 04-aug-2026 the implantation of seeg depth electrodes in one patient went smoothly and all implanted electrodes were recording.A planned post-operative ct scan was performed of the implanted electrodes.During the ct it was noted that there was a bleed.The patient was taken back to the or where they removed all of the electrodes, performed a craniotomy to remove a clot and used an aneurysm clip to stop the bleed.Post implant, the surgical team, reviewed the trajectories, data and surgical plan.It was confirmed that the implanted anchor bolts all matched the pre-planned trajectories, including trajectory 12.The ct scan showed that the tip of the electrode was off trajectory 12 by about 10 to 15 mm within 1 to 2 mm of entering the cranial space.The electrode tip entered the sylvian fissure and hit a branch of the middle cerebral artery resulting in a large bleed.Post-operatively the physician said that he wasn't sure what caused the electrode deviation, and that it could have been caused by a number of things, such as "vascular structure, dura mater deflection, or an incomplete drill hole." the physician commented that he didn't think that it was necessarily the electrode that inherently caused the deviation.The surgeon felt this was not due to inadequate planning, and no root cause was apparent.The patient was stable when they left the operating room on (b)(6) 2026.On (b)(6) 2026, an update from the nurse clinician stated that the patient is "doing great! just slightly weak still but didn't even meet criteria for inpatient rehab." no product was available for return.No further actions are needed at this time.

• Brand Name: EVO sEEG Electrode
• Common Device Name: Depth Electrode
• Manufacturer (Section D): NeuroOne Medical Technologies Corporation; 7599 anagram drive; eden prairie, MN 55344
• Manufacturer Contact: debra kridner ; 7599 anagram drive; eden prairie,; +1(763)443-4476
• MDR Report Key: 50487391
• Report Number: 3016438686-2026-00001
• Device Sequence Number: 10112266
• Product Code: GZL
• UDI-Device Identifier: 00856895008597
• UDI-Public: 00856895008597
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K222404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: Health Professional
• Device Model Number: NSEEG3410-RF
• Device Catalogue Number: NSEEG3410-RF
• Device Lot Number: N25C01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown