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

Model Number	DL-330-3.5-K
Medical Device Problem Codes	Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, the patient's mother reported that the patient's eyes were crossing.On (b)(6) 2025, a ct scan was performed.When the stimulation was turned off for the procedure, the eye turning stopped.The patient's epileptologist confirmed the patient's left thalamus (cm) depth lead had migrated.The migration may have resulted in stimulation and detection not being delivered at the intended location.On (b)(6) 2025 the patient underwent a lead repositioning.During the procedure, it was confirmed that the lead was loose at the dog bone.The lead was pulled back.There has been mention that the patient may have experienced a fall.
Additional Manufacturer Narrative
(b)(4).The lead and the rns neurostimulator 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: 21241579
• Report Number: 3004426659-2025-00003
• Device Sequence Number: 19748797
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217261006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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: 33748-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/27/2025
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 7 YR
• Patient Sex: Male