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 Codes	Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The patient underwent rns system placement on (b)(6) 2019.On (b)(6) 2019, the treating center performed a debridement and irrigation of the infected incision site.On (b)(6) 2019, the rns neurostimulator and leads were explanted.Additional details were not provided by the treating center.
Additional Manufacturer Narrative
(b)(4).The originally submitted 3004426659-2019-00026 should have been 3004426659-2019-00023.
Event or Problem Description
On (b)(6) 2019 the patient underwent a routine rns neurostimulator replacement due to expected low battery.On (b)(6) 2019, the patient underwent surgical debridement of the incision site to treat an infection.Following the debridement, the patient was noted to have developed wound erosion which was subsequently sutured closed on (b)(6) 2019.On (b)(6) 2019 the patient presented with continued erosion, and it was noted that the ferrule screw was observed through the skin erosion.The treating center scheduled the patient for surgical intervention on (b)(6) 2019.This patient has a history of scalp infections prior to implantation of the rns system.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca CA 94043
• MDR Report Key: 8695923
• Report Number: 3004426659-2019-00026
• Device Sequence Number: 19407985
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017191017
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2020

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: 1007694
• Device Lot Number: 27147-1-1-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/22/2019; 03/02/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 06/19/2019; 03/11/2020
• 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; Other
• Patient Age: 33 YR