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 Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) this is the patients second neurostimulator.Implant includes neurostimulator and two leads (cortical strip lead and a depth lead).

Event Description

It was reported to neuropace that the patient was seen for "oozing from the incision site" and placed on iv antibiotics.Additional information was requested from the treating center, however none was provided.

Manufacturer Narrative

(b)(4).Additional information was provided by the (b)(6) center: the patient had the system explanted on (b)(6) 2018.The explant included the neurostimulator as well as both the cortical strip and depth leads.The infection was categorized as deep incisional.Treatment included iv vancomycin this was the patient's second neurostimulator which was implanted on (b)(6) 2017.The initial implant occurred on (b)(6) 2014.

Event Description

New information was provided by the (b)(6) center.

Manufacturer Narrative

(b)(4).Additional information was provided by the treating center: the incorrect patient was previously reported as being explanted.It was confirmed with the site on 10/23/2018 that patient id (b)(6) had been explanted on (b)(6) 2018.

Event Description

New information was provided by the treating center.

• 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: 7342113
• MDR Text Key: 102512563
• Report Number: 3004426659-2018-00008
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170703
• 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,Followup
• Report Date: 11/15/2018

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-300M
• Device Catalogue Number: 1007910
• Device Lot Number: 24556-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/30/2018; 10/23/2018
• Supplement Dates FDA Received: 04/27/2018; 11/15/2018
• 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: 44 YR