MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	DL-330-3.5-K
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); Intracranial Hemorrhage (1891); Memory Loss/Impairment (1958)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the rns neurostimulator and leads remain implanted and programmed for use.
Event or Problem Description
The patient underwent seeg in 2022, and unfortunately suffered a hemorrhagic stroke as a complication.The patient was implanted with the rns system on (b)(6) 2023.This was about 6 months after the hemorrhage.Post-operative imaging showed an epidural hematoma under the neurostimulator.A surgical evacuation of the hematoma was done at that time.The patient did have some deficits after this complication (dysarthria).In (b)(6) 2025, the patient was assessed by the treating physician and was found to have worsening dysarthria.A head ct was done, which revealed migration of the left frontoparietal depth lead.The treating physician reported that it is unclear whether the lead migrated as a result of atrophy of the brain tissue related to the previous hemoatoma/hemorrhage, but feels this is a possibility.The patient had been following with another provider who had been getting serial head cts.The treating physician reviewed the serial head cts and found that the position of the depth lead has been stable since (b)(6) 2024.For now, stimulation remains on.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 24402219
• Report Number: 3004426659-2026-00017
• Device Sequence Number: 12803938
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217260106
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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
• Device Model Number: DL-330-3.5-K
• Device Catalogue Number: 1007928
• Device Lot Number: 33029-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male