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

Model Number RNS-320-K - FGI

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

Patient Problems Erosion (1750); Impaired Healing (2378); Drug Resistant Bacterial Infection (4553)

Event Date 05/12/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4); the explanted product was not returned to neuropace for analysis.

Event Description

On (b)(6) 2023, a scalp erosion was reported over the left rns neurostimulator.The patient presented with a low grade fever and swelling/redness around the eyes.On (b)(6) 2023 the patient underwent a wound exploration, washout and closure.There was no evidence of sub-galeal infections.Wound cultures were positive for mssa.On (b)(6) 2023 the eschar over the surgical wound fell off revealing erosion to the device.On (b)(6) 2023 the left rns neurostimulator and two leads were removed.No infection was noted at the time of explant.This was diagnosed as a superficial incisional erosion/infection.Treatment included oral amoxicillin-clavulanate.The right device and leads remain implanted.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: 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
• MDR Report Key: 17119685
• MDR Text Key: 317142149
• Report Number: 3004426659-2023-00024
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617230504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1008191
• Device Lot Number: 32647-1-1-1
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR
• Patient Sex: Male