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 Problem Bacterial Infection (1735)

Event Date 01/24/2023

Event Type  Injury  

Event Description

The patient was implanted on (b)(6) 2022.Patient reported an infection starting in (b)(6)2022.Patient was treated with antibiotics, and the infection reportedly resolved.The patient reported in (b)(6) 2022, a second infection and reportedly had a wound wash out.On (b)(6) 2023, neuropace was notified that the patient underwent a wound wash out and received antibiotics.This was diagnosed as an incision site infection.Cultures were positive for staphylococcus.

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.

• 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 ; 6502382788
• MDR Report Key: 16417936
• MDR Text Key: 309973526
• Report Number: 3004426659-2023-00007
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220823
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/14/2023

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: 1008191
• Device Lot Number: 31988-1-1-1
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/22/2023
• 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): Disability; Required Intervention; Life Threatening
• Patient Age: 37 YR
• Patient Sex: Female