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

Model Number	CL-325-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	08/24/2025
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
On (b)(6) 2025, the patient had a symptomatic hemorrhage around the strip electrode covering the left posterior superior temporal gyrus.It appears the patient had mri performed on (b)(6) 2025.The results of the mri were not provided.The patient was hospitalized for 6 days for observation.No surgical evacuation was needed.No other treatment was indicated.No residual neurological sequelae were observed.The physician reported that he was not entirely certain that it was an rns system related event, but other causes of hemorrhage had been ruled out.
Event or Problem Description
On (b)(6) 2025, the patient had a symptomatic hemorrhage around the strip electrode covering the left posterior superior temporal gyrus.The physician reported that he was not entirely certain that it was an rns system related event, but other causes of hemorrhage had been ruled out.The patient was hospitalized for 6 days.No surgical evacuation was needed.No other treatment was indicated.Device diagnostics and programming were performed to support clinical evaluation.No residual neurological sequelae were observed.The rns system remained implanted.
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: 23705977
• Report Number: 3004426659-2025-00077
• Device Sequence Number: 10670731
• Product Code: PFN
• UDI-Device Identifier: 00855547005311
• UDI-Public: 010085554700531117270123
• 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: 2024
• 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,Followup
• Report Date (Section B): 01/02/2026

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: CL-325-10-K
• Device Catalogue Number: 1007933
• Device Lot Number: 34044-1-1-1
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/02/2026
• 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: 50 YR
• Patient Sex: Female