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 Purulent Discharge (1812); Drug Resistant Bacterial Infection (4553)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2024, the patient was seen in clinic for a "spongy" feeling in surgical region.The patient was placed on antibiotics.On (b)(6) 2024, the patient reported worsening symptoms and was admitted for observation.The treating center made the decision to remove the device.On (b)(6) 2024, during explant, purulence was encountered soon after opening the skin.It was also obvious along hardware and beneath skin flap.Purulence was swabbed and sent for culture.The patient was started on empiric antibiotics.The patient was discharged on (b)(6) 2024.Acetaminophen, nafcillin and oxycodone were prescribed.

• 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: 18799180
• MDR Text Key: 336510270
• Report Number: 3004426659-2024-00020
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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: 33386-1-1-1
• Date Manufacturer Received: 02/02/2024
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female