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

Model Number	DL-330-10-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	12/13/2022
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 lead was explanted after the incision site showed signs of erosion.The lead was explanted.The treating site reported a diagnosis of erosion and superficial incisional infection.The patient's wife has reported that the infection has resolved.The patient is doing well.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
Update - this patient had the remaining lead and rns explanted on (b)(6) 2023.Reimplant is scheduled for (b)(6) 2023.Original report - the lead was explanted after the incision site showed signs of erosion.The treating site reported a diagnosis of erosion and superficial incisional infection.Culture results were not provided.

• 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: 16141416
• Report Number: 3004426659-2022-00055
• Device Sequence Number: 6529508
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517240720
• 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: 2022
• Device Explanted Year: 2022
• 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): 07/10/2023

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: DL-330-10-K
• Device Catalogue Number: 1007929
• Device Lot Number: 31671-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 07/11/2023
• 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: Other; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male