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); Drug Resistant Bacterial Infection (4553)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with possible infection at incision site.Treatment included incision site opening, pocket washout and antibiotics.Initially the patient was treated with antibiotic powder during wash out.Oral and iv antibiotics were administered.Device was disconnected temporarily to flush pocket and reconnected during same setting.On (b)(6) 2020 the rns system (neurostimulator and leads) was explanted.Diagnosed as a deep incisional infection.

Event Description

Patient presented with possible infection at rns system incision site.The patient was taken to the or on (b)(6) 2020 for washout of the incision site and treatment with antibiotic powder.Treatment also included iv and oral antibiotics.On (b)(6) 2020, the rns system (neurostimulator and all leads) was explanted.Diagnosed as a deep incisional infection.

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
• MDR Report Key: 10978981
• MDR Text Key: 220531903
• Report Number: 3004426659-2020-00061
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210212
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 29903-1-1-1
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR