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

Model Number RNS-300-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

Manufacturer Narrative

(b)(4).The originally submitted 3004426659-2019-00026 should have been 3004426659-2019-00023.

Event 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.

Manufacturer Narrative

(b)(4).

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca CA 94043
• MDR Report Key: 8695923
• MDR Text Key: 147898025
• Report Number: 3004426659-2019-00026
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017191017
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 03/02/2020
• Supplement Dates FDA Received: 06/19/2019; 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR