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

Model Number	DL-330-3.5K
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	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) evaluation of the patient ecogs and lead impedance.The review of the patient data was consistent with a potential lead break.
Event or Problem Description
At the (b)(6) 2025 doctor appointment, signal artifact was noted on the left thalamus (cm) depth lead, placed contralateral to the rns.The lead is secured with a dog bone with lead protection.Stimulation was disabled on the lead at the (b)(6) 2025 appointment.High impedance was noted in (b)(6) 2026 on the same lead.Signal artifact and high impedance are indicative of a lead break.The lead was replaced on (b)(6) 2026.

• 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: 25249711
• Report Number: 3004426659-2026-00053
• Device Sequence Number: 9489876
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217270805
• 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: 2026
• 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): 05/20/2026

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-330-3.5K
• Device Catalogue Number: 1007928
• Device Lot Number: 34564-1-1-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/21/2026
• 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; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Male