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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted device was not returned to neuropace for analysis.However, neuropace conducted a review of the patient's ecog recordings and stimulation path impedance data.Findings from this evaluation suggest a potential lead fracture.
Event or Problem Description
In preparation for the patient's clinic follow up visit, scheduled for (b)(6) 2025, the day prior, a neuropace employee undertook a pdms review of patient data and during ecog review, signal artifact and elevated impedance were observed on contact 4 of the right hippocampal depth lead.The following day, on (b)(6) 2025, the clinical evaluation revealed high impedance on contact 1.No changes were made to the stimulation programming during that visit.Due to persistent impedance abnormalities, the depth lead was replaced on (b)(6) 2025.At the time of the original implant, the right hippocampal longitudinal depth lead was secured using a burr hole cover.

• 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: 23031197
• Report Number: 3004426659-2025-00059
• Device Sequence Number: 9514699
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417191027
• 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: 2018
• Device Explanted 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): 09/11/2025

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-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 22889-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/11/2025
• 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: 31 YR
• Patient Sex: Male