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 Headache (1880); Unspecified Infection (1930)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6) 2016 - initial implant procedure lasted 3 hours, patient did not have vns and did not undergo invasive monitoring.This is the centers 12th implant.Vancomycin powder was used and the sutures were used at close.The system included the rns neurostimulator and two depth leads.Port 1 , sn (b)(4) left mesial temporal.Port 2 sn (b)(4) right mesial temporal - previous resection.Burr hole cover was used.Device not returned to manufacturer.

Event Description

(b)(6) 2017 the patient reported having 'headaches.' (b)(6) 2017- the patient had a ct scan.Seen at center where csf results and ct scan were abnormal.(b)(6) 2017 the patient was admitted and started on iv antibiotics.(b)(6) 2017 patient presented: to er reporting that 1 week prior to er visit, he had an increase in falls, headaches, chills, personality change, lethargy, decreased appetite, word confusion for five days.Fever observed in ed.Ct brain indicated bifrontal hypodensities.(b)(6) 2017-center notified fce that patient had undergone a complete explant of the rns system secondary to probable bacterial infection.Treatment details : (b)(6) 2017 - started broad spectrum abx: ceftriaxone, vancomycin, metronidazole, ampicillin and acyclovir then rns system was explanted.Placement of a picc for long term antibiotics.(b)(6) 2017 continuation of vancomycin, acyclovir, discontinue metronidazole, ampicillin, cefepime, start meropenem, (b)(6) 2017 discontinue acyclovir, (b)(6) 2017 discontinue meropenem, vancomycin, continue ceftriaxone (end of treatment (b)(6) 2017).(b)(6) 2017 the patient was discharged with iv antibiotics for 10 days.

• 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: 6346450
• MDR Text Key: 67870955
• Report Number: 3004426659-2017-00008
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170330
• 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: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• 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: 56 YR