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 Problem Stroke/CVA (1770)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2016 -the patient was implanted with the rns neurostimulator and three cortical strip leads (strip leads include: (b)(4) connected to port 1 placed right frontal superior, (b)(4) connected to port 2 placed right frontal middle, and (b)(4) not connected placed right frontal inferior) product remains implanted.

Event Description

Dr.(b)(6) explained that the patient (pt) suffered what was considered a stroke during the initial implant of her rns system.He did not fully understand the cause, but theorized that it may have been "strip lead irritation" during implant.Although the pt had noticeable deficits in motor and speech functions, i was told the pt had made great progress since implant in (b)(6) and continues to work with speech and physical therapists.This was the first time that neuropace was made aware of the post-surgery event.

• 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: 6279254
• MDR Text Key: 65829432
• Report Number: 3004426659-2017-00002
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017161229
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2016
• 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
• Patient Age: 51 YR