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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Swelling (2091)

Event Date 09/25/2014

Event Type  Injury  

Event Description

On (b)(6) 2014: the patient was implanted with the rns neurostimulator and four cortical strip leads (cl-315-10-k).The leads are placed as follows: two were placed in the left mesial temporal region and two were placed in the left temporal region.On (b)(6) 2014: dr.(b)(6) reported that her patient implanted on (b)(6) 2015 is complaining of speech-related issues and was admitted to the hospital.The patient's strip leads cover wernike's (speech) area.It was thought that the speech issues might be related to swelling and the steroid taper was modified and the patient sent home.On (b)(6) 2014: the patient was re-admitted for the same issues.Medical affairs received the following email from dr.(b)(6): "i have a patient here at (b)(6) recently implanted with neuropace electrodes who has developed some focal findings most likely attributable to swelling and vasogenic edema (now three weeks out).I wonder if we could talk about your experience with steroids following implantation.She is on a dexamethasone taper, and i will need to decide whether to extend the taper with watchful waiting or intervene." we responded to dr.(b)(6) with some information on the patients in our clinical trials that were on steroids.The patient's steroid taper was then again adjusted and she was sent home.We have heard nothing from the patient since.On 10/14/2014 -product monitoring notes - case review with dr.(b)(6) and (b)(6) (neuropace medical affairs team).Swelling / edema is an expected result of surgery, there is no indication that this issue was caused or contributed by the rns system.

Manufacturer Narrative

(b)(4).On 5/07/2015 neuropace, inc.Voided this complaint.There was no reported product malfunction.This is an anticipated behavior associated with lead placement and craniotomy procedures.On 07/21/2015 neuropace, inc.Reopened and reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with craniotomy procedures are reportable.There is no indication of product failure.Device remains implanted.

• 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: 4954107
• MDR Text Key: 6635029
• Report Number: 3004426659-2015-00022
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2015

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 NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 07/30/2015
• 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): Required Intervention
• Patient Age: 41 YR