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

Model Number	CL-325-10-K
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Speech Disorder (4415)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025 the patient underwent resection and implant.Postoperatively, the patient exhibited unspecified speech issues.A ct scan on (b)(6) 2025 revealed a small hemorrhage beneath a coiled left frontal strip lead wire.The wire was coiled under the dura, compressing a blood vessel and causing capillary backup, resulting in the hemorrhage.On (b)(6) 2025, the patient underwent a procedure to reposition the wire.Following successful repositioning, venous flow was restored.".The lead was secured with adhesive, and the skull was closed.As of (b)(6) 2025, the patient was recovering well.
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: 23647791
• Report Number: 3004426659-2025-00075
• Device Sequence Number: 20026242
• Product Code: PFN
• UDI-Device Identifier: 00855547005311
• UDI-Public: 010085554700531117280326
• 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: 2025
• 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): 11/25/2025

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: CL-325-10-K
• Device Catalogue Number: 1007933
• Device Lot Number: 35401-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/25/2025
• 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; Required Intervention; Hospitalization
• Patient Age: 18 YR
• Patient Sex: Male