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

Model Number	DL-344-3.5-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	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.The ecog and impedance data are suggestive of a potential lead break.
Event or Problem Description
Artifact signal was observed on the patient ecog around (b)(6) 2024.High impedance was also observed on the left thalamus central median (lcm) lead contact 1 and 2.A programming change was made on (b)(6) 2024 to disable stimulation on the lcm lead.The lead was replaced on (b)(6) 2025.Damage was observed on the explanted lead just distal of the entry point into the skull/ protective sleeve.The lead had been secured with a dog bone with lead protection.There was no reported fall or trauma which could have contributed to the break.

• 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: 22216276
• Report Number: 3004426659-2025-00037
• Device Sequence Number: 8619483
• Product Code: PFN
• UDI-Device Identifier: 00855547005359
• UDI-Public: 010085554700535917261107
• 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): 06/16/2025

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-344-3.5-K
• Device Catalogue Number: 1007930
• Device Lot Number: 33831-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/16/2025
• 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: Hospitalization; Other
• Patient Age: 8 YR
• Patient Sex: Male