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

Model Number RNS-300M

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

Patient Problems Edema (1820); Seizures (2063)

Event Date 07/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant included rns neurostimulator and two cortical strip leads.Port 1 cl-325-10, sn (b)(4), left temporal, anterior.Port 2 , cl-325-10, sn (b)(4), left temporal posterior lead.

Event Description

Neuropace was notified on july 9, 2017 that the patient was admitted for what appeared to be an ischemic stroke after presenting with a flurry of seizures on (b)(6).Clinically the patient reported a headache but no other symptoms were noted.As a precautionary measure, the site decided to disable therapy on the rns system on (b)(6), however detection remained enabled.After further evaluation, the center reported that the event did not appear to be an ischemic event but would continue to evaluate.As of (b)(6), the patient was reported to be stable and not exhibiting any stroke-like clinical symptoms.Imaging was reported to be more consistent with vasogenic edema than an ischemic stroke.Since the patient remained stable, no invasive interventions (e.G.Biopsy or explant of rns system product) were planned.At the time of report, the patient remained hospitalized for monitoring.

• 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: 6770782
• MDR Text Key: 81937475
• Report Number: 3004426659-2017-00033
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017160519
• 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: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M
• Device Catalogue Number: 1007603
• Device Lot Number: 21159-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2017
• 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
• Patient Age: 31 YR