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	Bacterial Infection (1735); Erosion (1750)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.
Event or Problem Description
On (b)(6) 2024 the patient presented with erosion at the incision site.The patient was diagnosed with a superficial incisional erosion and a wound washout was performed.On (b)(6) 2024, a second wound revision was performed to treat erosion at the incision site inclusive of a lead protrusion.Treatment also included antibiotic therapy; intraoperative vancomycin powder and intravenous ancef (cefazolin) (at the time of surgery).The rns neurostimulator and two depth leads remain implanted.The device is programmed for therapy.
Event or Problem Description
Neuropace received a patient update on (b)(6) 2025.The patient was previously treated for erosion and lead protrusion.New information reported the patient was prescribed keflex after developing a new wound breakdown at the previously treated incision site.The date of this treatment was not provided.The surgeon prescribed antibiotics two more times before explanting the rns system.On (b)(6) 2025, the surgeon explanted the rns system (neurostimulator and two depth leads).Event was originally reported on (b)(6) 2025.On (b)(6) 2024 the patient presented with erosion at the incision site.The patient was diagnosed with a superficial incisional erosion and a wound washout was performed.On (b)(6), 2024, a second wound revision was performed to treat erosion at the incision site inclusive of a lead protrusion.Treatment also included antibiotic therapy; intraoperative vancomycin powder and intravenous ancef (cefazolin) (at the time of surgery).At that time, the rns neurostimulator and two depth leads remained implanted and the device was programmed for therapy.
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: 21023394
• Report Number: 3004426659-2024-00080
• Device Sequence Number: 8330079
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817270103
• 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: 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): 04/02/2025

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: 1007931
• Device Lot Number: 33972-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 04/02/2025
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female