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

Model Number	DL-330-3.5-K
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient appointment summary - (b)(6) 2025 during the appointment, the patient's family reported observing an involuntary right elbow movement resembling a "chicken wing," which they initially suspected to be a seizure.The patient was last programmed on (b)(6) 2024, and these movements were first noted in (b)(6) 2025.Upon evaluation, the physician tested stimulation and confirmed that the patient's right elbow consistently extended during therapy delivery.The patient's device was programmed with the most distal contact on the left lead turned off.The physician expressed concern that the left lead may have shifted, as this phenomenon was not present previously and did not occur immediately following the (b)(6) last programming.Surgical intervention - (b)(6) 2025 the patient underwent a repositioning revision of the left thalamus (cm) depth lead.Intraoperatively, the surgeon noted significant soft tissue at the fixation site, which compromised the stability of the dog bone.To improve lead stability, the surgeon inverted the dog bone during the procedure.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.

• 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: 23694410
• Report Number: 3004426659-2025-00078
• Device Sequence Number: 10215944
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217270124
• 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
• 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): 12/01/2025

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-330-3.5-K
• Device Catalogue Number: 1007928
• Device Lot Number: 34048-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male