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

Model Number	RNS-300M-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The fce was notified that the patient had an infection and required a wound wash out.The rns and leads remain implanted.A full recovery is anticipated.No additional details were provided by the treating center.The rns system remains implanted and enabled for detection and therapy.
Additional Manufacturer Narrative
(b)(4).Additional details regarding the patient infection were provided by the treating center.It was clarified that the patient presented with a wound dehiscence and purulent drainage starting on (b)(6) 2018, which was diagnosed by the treating center as a deep incisional infection.The neuropace burr hole cover was explanted, however all other product remained implanted and functioning as intended.
Event or Problem Description
It was previously reported that the patient had experienced an infection but limited details had been provided by the treating center.Additional details have since been 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
• MDR Report Key: 7853776
• Report Number: 3004426659-2018-00034
• Device Sequence Number: 11045265
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017181115
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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
• Operator of Device: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007910
• Device Lot Number: 25453-1-1-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 YR