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

Model Number RNS-300M - KIT,

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

Patient Problems Bacterial Infection (1735); Increased Sensitivity (2065); Skin Erosion (2075)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient initial implant consisted of the rns neurostimulator and two strip leads, cl-325-10: port 1, sn (b)(4), right temporal and port 2, sn (b)(4), right temporal.

Event Description

Neuropace was notified on (b)(6) 2017 that during the patient's follow up visit up on (b)(6) 2017, the patient reported hitting her head on the edge of a desk several months prior, with tenderness at the incision site starting at that time.As of (b)(6) 2017, the erosion at the incision site was clearly visible and it was suspected that the erosion may have led to a possible infection.On (b)(6) 2017, the rns neurostimulator and leads were explanted and cultures were taken at the erosion site.

Manufacturer Narrative

(b)(4).Diagnosed by the treating center as an erosion that led to a superficial incisional infection pending return of explanted product.

Event Description

New information was provided by the treating center.

• 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: 6986827
• MDR Text Key: 90538055
• Report Number: 3004426659-2017-00048
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151211
• 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,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M - KIT,
• Device Catalogue Number: 1007603
• Device Lot Number: 20209-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• 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; Required Intervention
• Patient Age: 57 YR