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 11/28/2023

Event Type  Injury  

Event Description

The patient called her treating physician in the week before christmas and reported drainage at the incision site.She had no other signs/symptoms of infection, so she was instructed to monitor the site closely.Over the holiday weekend, she developed a fever.She was traveling for the holiday, so she went to a local community hospital, where she was seen.The rns system was explanted, reportedly due to infection.The treating epileptologist and surgeon have been trying to get details from the community hospital, but have not been able to get any information.The community hospital has not been responsive to numerous requests for information from neuropace.

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: 18536727
• MDR Text Key: 333156374
• Report Number: 3004426659-2024-00002
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617240605
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 33593-1-1-1
• Date Manufacturer Received: 12/19/2023
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female