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

Model Number	RNS-320-K K
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): the rns is in process of being investigated.
Event or Problem Description
The patient's ecog data indicated the left mesial temporal depth lead had high impedance, indicative of a lead break.During the scheduled lead replacement surgery, the surgeon elected to replace the rns neurostimulator.The rns neurostimulator was replaced and the left mesial temporal depth lead was connected to the new rns neurostimulator.Live ecog indicated that the lead was functioning as expected with no high impedance.The surgeon elected to leave the lead in place after the rns was replaced.The cause appears to be related to a fall experienced in (b)(6) 2025.
Additional Manufacturer Narrative
(b)(4).Investigation results - rns was received in passive mode.The root cause for the reported high lead impedance was not isolated.Plausible explanations for the high lead impedance include undetected damage to the lead that resulted in an intermittent contact or a poor connection at the interface of the proximal lead contact to the patient feedthru.No fault was isolated to the rns.
Event or Problem Description
Section h10 has been updated with the investigation results.Original report - the patient's ecog data indicated the left mesial temporal depth lead had high impedance, indicative of a lead break.During the scheduled lead replacement surgery, the surgeon elected to replace the rns neurostimulator.The rns neurostimulator was replaced and the left mesial temporal depth lead was connected to the new rns neurostimulator.Live ecog indicated that the lead was functioning as expected with no high impedance.The surgeon elected to leave the lead in place after the rns was replaced.The cause appears to be related to a fall experienced in (b)(6) 2025.

• 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: 24737488
• Report Number: 3004426659-2026-00030
• Device Sequence Number: 9269567
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220211
• 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: 2021
• 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,Followup
• Report Date (Section B): 04/08/2026

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: RNS-320-K K
• Device Catalogue Number: 218642
• Device Lot Number: 31029-1-1-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/09/2026
• 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: Hospitalization; Other
• Patient Age: 34 YR
• Patient Sex: Male