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

Model Number	DL-344-3.5-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Intracranial Hemorrhage (1891); Speech Disorder (4415)
Date of Event	09/21/2025
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 reported feeling that "things were off" prior to admission on (b)(6) 2025.According to the patient's spouse, symptoms began approximately two weeks before hospitalization and were characterized by slurred speech and word-finding difficulties, indicative of impaired speech.The exact onset date was not provided.These symptoms reportedly worsened during hospitalization.On (b)(6) 2025, the patient was admitted for an intracranial hemorrhage measuring approximately 18 mm, located near the right depth lead implantation site.Review of ecog data indicated an increase in long-episode activity between (b)(6) and (b)(6), which the healthcare provider suspects may be associated with the hemorrhage.No medical intervention was performed during hospitalization.An mri appears to have been conducted on (b)(6) 2025, based on available patient data; however, results were not provided.The patient demonstrated clinical improvement on the final day of hospitalization and was discharged on (b)(6) 2025.The etiology of the hemorrhage remains undetermined.(b)(6) 2025 during a follow up the patient showed substantial improvement to almost resolute improvement.The patient continues to report headaches.All other associated symptoms have resolved.

• 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: 23694412
• Report Number: 3004426659-2025-00089
• Device Sequence Number: 18695985
• Product Code: PFN
• UDI-Device Identifier: 00855547005359
• UDI-Public: 010085554700535917240325
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DL-344-3.5-K
• Device Catalogue Number: 1007930
• Device Lot Number: 31035-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male