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 Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Twiddlers Syndrome (4563)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient was seen in clinic with fever and wound dehiscence.He was prescribed a 14 day course of iv keflex.At follow up in (b)(6) 2026, improvement of the incision site was noted.In (b)(6) 2026, the patient returned with recurrent wound dehiscence and purulent drainage.On (b)(6) 2026, he underwent explantation of the rns system (neurostimulator and two leads) with irrigation and debridement of the infected area.Initial cultures grew staphylococcus epidermidis, and he was treated with iv vancomycin and cefepime through (b)(6) 2026.On (b)(6) 2026, due to persistent wound healing difficulties, the patient returned to the operating room for repeat irrigation and debridement.Cultures were positive for staphylococcus capitis.He was treated with four weeks of iv vancomycin and two weeks of linezolid.On evaluation on 5/4/26, the wound was noted to be healed.
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: 25178187
• Report Number: 3004426659-2026-00042
• Device Sequence Number: 10692837
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617260422
• 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
• 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
• Report Date (Section B): 05/14/2026

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: 35578-1-1-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• 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: 17 YR
• Patient Sex: Male