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

Model Number	DL-330-3.5-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Nausea (1970); Decreased Level of Consciousness (4591)
Date of Event	03/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns neurostimulators and leads remain implanted and programmed for use.
Event or Problem Description
On (b)(6) 2025, the patient presented to the (b)(6) emergency room with nausea, vomiting, and a decreased level of consciousness.A ct scan was performed and showed a large left frontal hematoma in the area of the left thalamus (cm) depth lead.Surgical evacuation of the hematoma was performed.The left neurostimulator was removed to visualize and treat the blood clot on the surface.The neurostimulator was then replaced.There was no report of a fall or trauma.The post-op ct scan showed full evacuation of the hematoma.The patient is no longer hospitalized and the hematoma is now 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: 21659739
• Report Number: 3004426659-2025-00019
• Device Sequence Number: 18327241
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217260724
• 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: 2023
• 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): 03/20/2025

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
• Device Model Number: DL-330-3.5-K
• Device Catalogue Number: 1007928
• Device Lot Number: 33521-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 03/20/2025
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female