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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Neuropace confirmed the ecog and impedance data are suggestive of a potential lead break.Neuropace investigated the returned lead.We confirmed lead damage to the lead coil which could be associated with the dog bone clamp fixation.The returned lead was returned with significant damage, possibly related to the explant process, making the root cause inconclusive.
Event or Problem Description
On (b)(6) 2025 evidence of a suspected lead break was observed on the patient's ecog.The ecog data displayed low impedance and signal artifact on channel 1 of the left mesial temporal hippocampal depth lead (secured with dog bone with lead protection).On (b)(6) 2025 the patient underwent a lead revision.The lead was returned to npce for investigation.

• 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
• MDR Report Key: 22927030
• Report Number: 3004426659-2025-00051
• Device Sequence Number: 18432313
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817270325
• 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
• 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): 08/29/2025

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: 1007931
• Device Lot Number: 34203-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/29/2025
• 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: 60 YR
• Patient Sex: Female