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

Model Number	DL-333-3.5-K
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating facility reported the patient had a small bump close to the incision site.A ct showed the dog bone and lead were intact and correctly placed, so it was suspected the lead protector of the left occipital depth lead had slipped out from under the dog bone.On (b)(6) 2026, an adjustment was made to the lead fixation.The plastic lead protector had slipped from under the dog bone, causing a bump under the scalp.The surgeon fixed the issue with no complications to the lead.The dog bone and lead protector were revised to prevent further slippage with no complications.
Additional Manufacturer Narrative
(b)(4) the device remains implanted and programmed for use.

• 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: 24564621
• Report Number: 3004426659-2026-00020
• Device Sequence Number: 9466799
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217280826
• 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: 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): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DL-333-3.5-K
• Device Catalogue Number: 1007928
• Device Lot Number: 35823-1-1-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/10/2026
• 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; Required Intervention; Other
• Patient Age: 20 YR
• Patient Sex: Female