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 Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 12/02/2023

Event Type  Injury  

Event Description

The patient was reported to have a wound/infection issue.The patient underwent an explant.Details from the treating center are pending.

Manufacturer Narrative

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

Event Description

Onset date was reported as 12/1/23.The patient reported purulent discharge from his post-op incision.The patient was reported to have poor wound healing/infection.Dehiscence of the incision site was noted.The rns system (neurostimulator and two leads) was explanted on (b)(6) 2023.Treatment included oral and iv antibiotics.Diagnosed as deep incisional infection and osteomyelitis.

Manufacturer Narrative

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

• 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: 18681480
• MDR Text Key: 335072433
• Report Number: 3004426659-2024-00005
• 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,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 33497-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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; Other; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female