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 Drug Resistant Bacterial Infection (4553)

Event Date 11/19/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Infection onset date was reported as (b)(6) 2022.The patient had an rns implantation on (b)(6) 2022.On (b)(6) 2022 the rns system (neurostimulator and two leads) was explanted due to infection (incision site, infected neurostimulator device with presumptive cranial osteomyelitis).Treatment also included vancomycin 1250 mg iv every 8 hours, start date (b)(6) 2022.Resolved with treatment.Diagnosed as deep incisional infection with osteomyelitis.Neuropace personnel was not present at explant, procedure details are not known.

• 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: 18655693
• MDR Text Key: 334725038
• Report Number: 3004426659-2024-00013
• Device Sequence Number: 1
• Product Code: PFN
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1008191
• Device Lot Number: 32253-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization; Other
• Patient Age: 25 YR
• Patient Sex: Female