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 Bacterial Infection (1735); Unspecified Infection (1930); Staphylococcus Aureus (2058); Discharge (2225)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns system remains implanted and programmed for use.

Event Description

The patient reported she had been experiencing several months of purulent drainage from both the incisions located near the burr holes.Due to personal reasons (loss of healthcare insurance and fear of surgery), the patient decided to delay seeking treatment for these issues until (b)(6) 2020.Once seen by the treating center, the patient was scheduled for a wound washout, removal of the left burr hole cover and was started on antibiotics for 4 weeks.Additional treatment will be pursued if the infection does not resolve.The treating center described the event as a deep incisional infection.

Manufacturer Narrative

(b)(4).

Event Description

The treating center provided culture results to neuropace.

Manufacturer Narrative

(b)(4).As previously reported the patient underwent wound washout, removal of the left burr hole cover and was started on antibiotics.The infection persisted, resulting in the explant of the rns system (neurostimulator and all leads).No other additional information was provided by the treating center.

Event Description

The treating center provided additional information regarding the patient's status.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• MDR Report Key: 10075134
• MDR Text Key: 191585610
• Report Number: 3004426659-2020-00017
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200423
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 28164-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR