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

Model Number	DL-344-3.5-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	05/09/2024
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 was implanted with the rns neurostimulator and four leads.On (b)(6) 2024 the patient was admitted to the hospital for difficulty with word forming.Hemorrhaging was identified to be near two of the left parietal (lpar) lead electrodes and a questionable hemorrhage near the burr hole cover.The patient was prescribed seven (7) days of steroids.The patient was discharged on (b)(6) 2024.On (b)(6) 2024 the patient received another five (5) day course of steroids.The aphasia resolved after the second course of steroids.The patient was seen on (b)(6) 2024, the symptoms have resolved.The patients rns system is now programmed for detection and stimulation.

• 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: 19522036
• Report Number: 3004426659-2024-00040
• Device Sequence Number: 18227153
• Product Code: PFN
• UDI-Device Identifier: 00855547005359
• UDI-Public: 010085554700535917270123
• 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
• 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): 06/10/2024

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: DL-344-3.5-K
• Device Catalogue Number: 1007930
• Device Lot Number: 34037-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/12/2024
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male