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); Sepsis (2067); Twiddlers Syndrome (4563)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient presented with drainage and redness at the rns system incision site.After further investigation it was determined that the patient had been picking at the incision site, resulting in wound dehiscence and infection.Treatment included administration of antibiotics.

Manufacturer Narrative

(b)(4).The treating clinician reported the patient continued to have drainage from the dehisced incision site.However, the patient continued to pick at her incision impairing the ability of the incision to heal.A wound cleaning was performed on (b)(6) 2021.On (b)(6) 2021, the patient presented with sepsis and underwent removal of the rns system (neurostimulator and all leads).No other information was provided by the treating center.The explanted product was not returned to neuropace for analysis.

Event Description

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

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 10939321
• MDR Text Key: 219319010
• Report Number: 3004426659-2020-00059
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200604
• 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
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• 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: 1007927
• Device Lot Number: 28458-1-1-1
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR