MAUDE Adverse Event Report: NEUROPACE,INC NEUROPACE RNS SYSTEM

Model Number RNS-300M-K

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

Patient Problems Bacterial Infection (1735); Skin Erosion (2075)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is the patients 5th neurostimulator for 12/22/2015 patient had incision dehiscence from the replacement performed on (b)(6) 2015.The ferrule was explanted and a new ferrule was re-seated deeper in skull bone.Plastic surgeon closed incision using 2 layers of interrupted sutures.Reference 3004426659-2015-00034, (b)(4).Device remains implanted.

Event Description

Dehiscence at neurostimulator site, patient noted "oozing" from her neurostimulator site on (b)(6) 2016.She contacted plastic surgeon who evaluated her that day.The plastic surgeon referred her to neurosurgeon who evaluated her on (b)(6) 2016.Plan is to monitor site for further changes with no planned surgical intervention.No antibiotics were prescribed.There is no indication of product failure.The rns system remains programmed for detection and therapy.

Manufacturer Narrative

On (b)(6) 2017 the patient synchronized their remote monitor resulting in neuropace becoming aware that the patient's neurostimulator had experienced a dc leak reset on (b)(6) 2017.Since the reset had not been cleared, the patient had not been receiving responsive stimulation since that date.Upon communication with the treating center on (b)(6) 2017, it was determined that the patient underwent a surgical procedure in the area of the neurostimulator on (b)(6) 2017 to implant a tissue expander as part of the treatment strategy for the ongoing wound dehiscence; however the procedure was unsuccessful as the expander was too large and could not be placed.The patient was subsequently provided a referral to an outside institution for a plastic surgery consult.The surgical procedure resulted in the dc leak reset reported by the neurostimulator.On (b)(6) 217, the treating center reported that the patient decided to leave the neurostimulator off as it will be explanted soon.The patient will be going to (b)(6) to have the neurostimulator explanted and plastic surgery performed to aid in wound healing.Additional information provided by the site: on (b)(6) 2017 - subject called with updated information.Area of dehiscence at stimulator implant site on scalp continues to have an open area according to subject.She has an upcoming appointment with neurosurgeon for re-evaluation.On (b)(6) 2017 she saw neurosurgeon and plastic surgeon.Recommendation for surgery, implanting a tissue expander to close the dehisced site.Wound culture by neurosurgeon was negative for infection.

Event Description

As of 8/7/2017 new information became available regarding the patient's situation.

Manufacturer Narrative

(b)(4).On (b)(6) 2017 the patient underwent explant of the rns neurostimulator and one depth lead (the other lead was left implanted) at (b)(6).A skin graft from the thigh and scalp were used to close the open area in the scalp.No postoperative complications were reported.Wound cultures were taken by infectious disease; however the results were not available at the time of this report.The patient was discharged with two antibiotics on (b)(6) 2017.A follow-up appointment with the plastic surgeon was scheduled for (b)(6) 2017.The site reports that the cause of the continued problem with dehiscence is due to the patient's thin skin and probable infection.

Event Description

As of 11/29/2017 new information became available to neuropace, inc.

Manufacturer Narrative

(b)(4).Cultures taken at surgery on (b)(6) 2017 - results presented.A follow-up appointment was conducted on (b)(6) 2017 at which the graft was felt to be settling in.Antibiotics were continued per infectious disease.

Event Description

As of 01/02/2018 new information became available to neuropace, inc.

• 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 ; 6502372788
• MDR Report Key: 5963549
• MDR Text Key: 55147353
• Report Number: 3004426659-2016-00023
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017160128
• 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 Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 20655-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: 08/08/2017; 11/29/2017; 01/02/2018
• Supplement Dates FDA Received: 09/06/2017; 12/27/2017; 01/30/2018
• 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; Other; Required Intervention
• Patient Age: 66 YR