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

Model Number RNS-320-K

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

Patient Problem Unspecified Infection (1930)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 the patient had her rns and two leads explanted for infection.Neuropace personnel were not present at explant so procedure details are not known (b)(6) 2021 patient visit notes - the patient had clear oozing around incision sight.Patient went straight down to surgeon's office after clinic visit to have nurse look at incision.Rn took a photo and surgeon to consult if needed.Npce was called on (b)(6) 2021 by the surgeon that after 2 weeks of broad spectrum antibiotics, he was going to explant leads/device.(b)(6) 2021 patient visit notes - the patient was explanted on (b)(6) 2021 due to infection from cat licking wound during healing process.(b)(6) 2022 patient visit notes - the patient was reimplanted on (b)(6) 2022 and is doing well.

• 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: 18582147
• MDR Text Key: 333748312
• Report Number: 3004426659-2024-00012
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220109
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30925-1-1-1
• Date Manufacturer Received: 08/07/2021
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female