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

Model Number	DL-330-3.5-K
Medical Device Problem Codes	High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) / (b)(4) product not returned for investigation.First lead reported to the fda 3004426659-2024-00037.
Event or Problem Description
During review of the patient ecog data, high impedance were observed on the left lead ((b)(6)).This is indicative of a lead break.Artifact was duplicated when the physician palpated around the head.Evidence of high impedance was noted to have started around(b)(6) 2023.Detection was modified.There is no report of a fall or trauma that could have contributed to a lead break.On (b)(6) 2024 - after performing an interrogation on the patient, impedances 2 and 3 on the right lead (sn (b)(6)) were flat and contact 3 on the left lead ((b)(6)) exhibited similar behavior.This supports the hypothesis of a suspected lead fracture on both leads, as impedances should be normal and every time they were measured, they were abnormal.On (b)(6) 2024, the patient underwent lead explants.Both thalamic leads (right and left) that are suspected to be fractured were removed along with the rns neurostimulator.The patient is scheduled to have a reimplant, of the rns system after an mri is performed to establish new thalamic lead targets.There is no indication of a rns neurostimulator failure.Reimplant of the rns system is scheduled for (b)(6) 2024.

• 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: 19305884
• Report Number: 3004426659-2024-00038
• Device Sequence Number: 6438209
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817190511
• 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: 2017
• Device Explanted 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
• Report Date (Section B): 05/13/2024

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-330-3.5-K
• Device Catalogue Number: 1007604
• Device Lot Number: 22189-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/13/2024
• 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; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female