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 Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The fce was notified that the patient had an infection and required a wound wash out.The rns and leads remain implanted.A full recovery is anticipated.No additional details were provided by the treating center.The rns system remains implanted and enabled for detection and therapy.

Manufacturer Narrative

(b)(4).Additional details regarding the patient infection were provided by the treating center.It was clarified that the patient presented with a wound dehiscence and purulent drainage starting on (b)(6) 2018, which was diagnosed by the treating center as a deep incisional infection.The neuropace burr hole cover was explanted, however all other product remained implanted and functioning as intended.

Event Description

It was previously reported that the patient had experienced an infection but limited details had been provided by the treating center.Additional details have since been provided.

• 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: 7853776
• MDR Text Key: 119488505
• Report Number: 3004426659-2018-00034
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017181115
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007910
• Device Lot Number: 25453-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• 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: 18 YR