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

Model Number	RNS-300-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/19/2021
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 patient was explanted due to an infection that started and persisted since seeg removal.Note that seeg removal ((b)(6) 2019) occurred prior to the date of initial placement of the rns system ((b)(6) 2019).A wound washout was performed at the incision site (date unspecified).The patient was placed on multiple antibiotics prior to referral to infection control.A second opinion was obtained at another comprehensive epilepsy center where the patient was advised to have the device explanted.The rns system (neurostimulator and all leads) were explanted at the explanting center on (b)(6) 2021.Diagnosed as a superficial incisional infection.

• 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: 11532513
• Report Number: 3004426659-2021-00016
• Device Sequence Number: 5169897
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017200411
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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-300-K
• Device Catalogue Number: 1007910
• Device Lot Number: 28609-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/19/2021
• 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: Other
• Patient Age: 53 YR