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); Fluid Discharge (2686)

Event Date 05/05/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported to the hospital with significant drainage at the surgical site.The patient underwent explant of the rns system (neurostimulator and two depth leads) on (b)(6)2023.Treatment included a six week course of iv antibiotics.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
• MDR Report Key: 17039139
• MDR Text Key: 316313725
• Report Number: 3004426659-2023-00022
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210805
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/30/2023

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 Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1007927
• Device Lot Number: 30274-1-1-1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/01/2023
• 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; Other
• Patient Age: 52 YR
• Patient Sex: Female