MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number 1007603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Discharge (2225)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) review of sterility records was performed.No evidence of factors that could have caused or contributed to the reported event.Product not returned.

Event Description

Per nurse coordinator at (b)(6): patient presented to clinic with probable infection.The entire system including leads, were explanted.Patient will require 4 weeks iv vancomycin.Infection started within about 7-10 days of implant.Patient called and described enlarged lymph nodes, and saw his pcp.Patient was started on po (oral) antibiotics at that time, and the problem was thought to have resolved.However last week patient called saying he had purulent drainage from his neurostimulator site.He told me that he has scratched the wounds, and this very possibly the cause.He will probably be discharged tomorrow (tuesday).We are just putting home iv therapy in place and making sure he has good support.Id (infectious diseases) is following him and will see him in 2-3 weeks.We will see him in n/surgery clinic in (b)(6).The patient was seen on thurs (b)(6) by infectious diseases.The vancomycin was stopped.The culture came back (b)(6).He has been given mupirocin to decolonize prior to next surgery.The plan is to re-implant in the future as he had recorded early benefit.

• 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 ; 6502382788
• MDR Report Key: 5758256
• MDR Text Key: 48441815
• Report Number: 3004426659-2016-00015
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017160526
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR