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

Model Number	RNS-320-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the explanted product was not returned to neuropace for analysis.
Event or Problem Description
Ms.(b)(6) is a 37 y.O.Woman with focal cortical dysplasia leading to seizures, treated with a neurostimulation device who underwent an explant on (b)(6) 2025.She had a reimplant on (b)(6) 2025 due to issues with her leads which was complicated by purulent drainage/skin breakdown and hardware exposure.She was taken to the or (b)(6) 2025 for washout and a closure with plastic surgery for a retained device, treated with ceftriaxone followed by amoxicillin with cultures growing c acnes.Completed amoxicillin (b)(6) 2025.Neuropace reported this to the fda through 3004426659 -2025-00046 / (b)(4).Interval history the patient then developed a recurrent cranial wound breakdown/drainage and was taken for rns neurostimulator removal on (b)(6) 2025, followed by the inpatient infectious disease consultation.Cultures grew s.Epidermidis and c.Acnes she was initially treated with vancomycin but developed leukopenia so was switched to daptomycin.When c.Acnes began to grow; iv penicillin was added for better coverage.The picc line had been removed and she was placed on antibiotic suppression with: doxycycline 100mg bid for 24 days and amoxicillin 1,000mg tid for 24 days until (b)(6) 2025.We then re implanted her with the rns on (b)(6) 2026 without issue.

• 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: 24678692
• Report Number: 3004426659-2026-00026
• Device Sequence Number: 9977339
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617251213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: RNS-320-K
• Device Catalogue Number: 1008191
• Device Lot Number: 35131-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/24/2026
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female