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	Erosion (1750); Implant Pain (4561)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient reported to the epileptologist, concerns regarding an indentation around the rns neurostimulator with pain/ throbbing.The epileptologist referred her to neurosurgery for evaluation.On (b)(6) 2024, additional surgery was performed by plastics and neurosurgery.The patient underwent surgery to address erosion/ defect of the patient's skull.Treatment included the use of plates to bridge any gaps.Neurosurgery decided to replace the neurostimulator at the same time.Treatment included standard intra-operative antibiotics in site and intraveneously.
Additional Manufacturer Narrative
Comp (b)(4) the explanted product was not returned to neuropace for analysis.There is no indication of product failure or malfunction.

• 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: 20622767
• Report Number: 3004426659-2024-00070
• Device Sequence Number: 8749390
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200808
• 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: 2019
• Device Explanted Year: 2024
• 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): 11/06/2024

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: 1007694
• Device Lot Number: 29126-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female