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

Model Number	DL-344-10-K
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Visual Impairment (2138)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent initial implantation of the rns system on (b)(6) 2025.Post operatively, the patient experienced an intraparenchymal hemorrhage at the entry site of the right hippocampal depth lead.The patient reported peripheral vision loss on the corresponding side.No surgical intervention was performed; however, the patient was admitted to the intensive care unit.Treatment included administration of nayzilam for focal impaired seizures on the day of the hemorrhage ((b)(6)), along with corticosteroids.The patient remained hospitalized for two days.The hemorrhage is suspected to be associated with a deviation from the planned trajectory, potentially due to inaccuracy of the neuromate robotic system.
Additional Manufacturer Narrative
(b)(4) the rns neurostimulator and leads remain implanted and programmed for use.
Event or Problem Description
Additional information: the neurosurgeon confirmed this was an adverse event, but one that he did not attribute to the neuromate robotic system nor the rns device.Original report: the patient underwent initial implantation of the rns system on (b)(6) 2025.Post operatively, the patient experienced an intraparenchymal hemorrhage at the entry site of the right hippocampal depth lead.The patient reported peripheral vision loss on the corresponding side.No surgical intervention was performed; however, the patient was admitted to the intensive care unit.Treatment included administration of nayzilam for focal impaired seizures on the day of the hemorrhage ((b)(6)), along with corticosteroids.The patient remained hospitalized for two days.The hemorrhage is suspected to be associated with a deviation from the planned trajectory, potentially due to inaccuracy of the neuromate robotic system.
Additional Manufacturer Narrative
(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.

• 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: 23709291
• Report Number: 3004426659-2025-00074
• Device Sequence Number: 16132546
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817280721
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007931
• Device Lot Number: 35691-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 34 YR
• Patient Sex: Male