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

Model Number	RNS-320-K - FGI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Intracranial Hemorrhage (1891); Pain (1994)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A few months after implant the patient reported skull pain.Over the years he occasionally reported skull pain, headaches and more recently pain throughout his body.The patient was admitted for evaluation.The patient requested that the rns be removed.On (b)(6) 2023 the patient underwent a complete rns system explant (neurostimulator, leads, and burr hole covers).Treatment also included surgical evacuation.The doctor reported the patient suffered subdural hemorrhaging following the procedure.The patient was admitted to icu on (b)(6) 2023 for subdural hemorrhage following explant.He is currently intubated and has a feeding tube.The cause of the patient's pain was not determined.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
A few months after implant ((b)(6)) the patient reported skull pain.The patient continued to occasionally report skull pain and headaches for approximately five years post implant.More recently he reported pain throughout his body.In (b)(6) 2023, the patient was admitted for evaluation.The patient requested that the rns be removed.On (b)(6) 2023 the patient underwent a complete rns system explant (neurostimulator, leads, and burr hole covers).Treatment also included surgical evacuation.Prior to explant, the doctor reported that the patient had scarring around the subdural strip lead, there was no report of hemorrhaging.The doctor reported the patient suffered subdural hemorrhaging following the procedure.The patient was admitted to icu on (b)(6) 2023 for subdural hemorrhage following explant.The cause of the patient's pain was not determined.

• 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: 17685884
• Report Number: 3004426659-2023-00044
• Device Sequence Number: 6281624
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190402
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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 - FGI
• Device Catalogue Number: 1007694
• Device Lot Number: 25944-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 40 YR
• Patient Sex: Male