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 Bacterial Infection (1735); Erosion (1750); Fluid Discharge (2686)

Event Date 09/20/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient presented with drainage and exposed hardware from the incision site.On (b)(6) 2023, the patient underwent a rns system explant (rns neurostimulator and two depth leads).Treatment included iv oxacillin through (b)(6) 2023.This was diagnosed as a deep incisional infection.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Resubmission of 3004426659-2023-00051.Correction to original submission of this mdr.On (b)(6) 2023, the patient presented with drainage and exposed hardware from the incision site.On (b)(6) 2023, the patient underwent an rns system explant (rns neurostimulator and two depth leads).Treatment included iv oxacillin through on (b)(6) 2023.This was diagnosed as a deep incisional infection.

• 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 ; 5108822607
• MDR Report Key: 17882245
• MDR Text Key: 325063221
• Report Number: 3004426659-2023-00051
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210813
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1007927
• Device Lot Number: 30692-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male