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

Model Number	DL-344-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Impaired Healing (2378); Twiddlers Syndrome (4563)
Date of Event	05/02/2025
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
The patient's left posterior depth lead eroded through her scalp while traveling in (b)(6) area.The patient's (b)(6) team recommended she go to the er, where she was seen under the care of dr.(b)(6).The explanted depth lead was not connected to the rns neurostimulator.Unspecified oral antibiotics were administered.
Additional Manufacturer Narrative
(b)(4) the explanted product was not returned to neuropace for analysis.
Event or Problem Description
New information: on (b)(6) 2025 the patient returned to the operating room (b)(6) to address the wound at the left posterior entry site for a 10 mm hippocampal depth lead.Treatment included a wound wash out, explant of the burr hole cover and remaining portion of the depth lead.Plastic surgical consult assisted with closure.The patient reportedly has been 'picking' at the wound, which resulted in the continuation of the wound healing concerns.There was no evidence of infection.Based on this new information it is believed that sn (b)(6) was not the lead that was explanted in (b)(6) 2025.It is believed that sn (b)(6) was partially explanted in (b)(6) 2025.Original report.The patient's left posterior depth lead eroded through her scalp while traveling in (b)(6) area.The patient's columbia team recommended she go to the er, where she was seen under the care of dr.(b)(6).The explanted depth lead was not connected to the rns neurostimulator.Unspecified oral antibiotics were administered.

• 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: 22180953
• Report Number: 3004426659-2025-00034
• Device Sequence Number: 8616894
• Product Code: PFN
• UDI-Device Identifier: 00855547005021
• UDI-Public: 010085554700502117210814
• 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: 2014
• Device Explanted Year: 2025
• 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): 08/14/2025

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: DL-344-10-K
• Device Catalogue Number: 1007438
• Device Lot Number: 18414-1-1-1
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 47 YR
• Patient Sex: Female