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

Model Number	RNS-320-K
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned neurostimulator is in process of being investigated.
Event or Problem Description
The neurostimulator battery reached end of service after 2.156 years.The battery was replaced on (b)(6) 2026.Review of the battery plot indicated an unusual battery depletion pattern.The neurostimulator was returned to neuropace for investigation.
Additional Manufacturer Narrative
(b)(4).Investigation indicated that the neurostimulator sustained electrical overstress (eos) during exposure to an electrosurgical unit (esu) at the time of implant resulting in excessive battery drain when stimulation is active (vdacres is charged).
Event or Problem Description
H10 investigation results: original report: the neurostimulator battery reached end of service after 2.156 years.The battery was replaced on 4/17/26.Review of the battery plot indicated an unusual battery depletion pattern.

• 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: 25142615
• Report Number: 3004426659-2026-00043
• Device Sequence Number: 15827675
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617241004
• 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
• 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): 06/23/2026

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
• Device Catalogue Number: 1008191
• Device Lot Number: 33904-1-1-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/24/2026
• 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: Required Intervention; Other; Death; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male