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 Head Injury (1879); Injury (2348)

Event Date 07/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2017 the patient was treated for impaired healing of the incision site; this event was reported to the fda (3004426659-2017-00032).Initial implant included the rns neurostimulator and two leads.Port 1 - dl-344-10, sn (b)(4), left mesial temporal.Port 2 - cl-335-10, sn (b)(4), right temporal non mesial.

Event Description

On (b)(6) 2017 neuropace was notified that the patient had been working in the garden and a tool fell on her head, opening her rns neurostimulator incision site.She was taken to surgery to debride and close the incision.Stimulation was disabled at that time by the center as a precautionary measure.

• 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: 6817235
• MDR Text Key: 83509983
• Report Number: 3004426659-2017-00037
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170608
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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: 22882-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• 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; Required Intervention
• Patient Age: 65 YR