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 Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant for this patient, system consists of - rns (located in the right parietal region) and 3 strip leads, port1, cl-325, sn (b)(4), right front interhemispheric.Port 2, cl-325, sn (b)(4), right parietal sensor, not connected, cl-325, sn (b)(4) right frontal motor.

Event Description

System explanted to treat infection.On (b)(6) 2017 the patient presented to the emergency department with an increasing headache.A head ct was performed and found to be within normal limits.The patient returned to er on (b)(6) 2017 with a fever and purulent discharge from the incision site.Patient stated he had been experiencing fevers for the past 3 days.He also reported that he had noticed drainage from the incision site starting the evening of (b)(6), worsening headaches and 2 days of weakness in his left upper extremity.Head ct showed fluid collection under right scalp with a fistula going to surface of scalp.Patient was taken to or on the same day for right frontal parietal washout with removal of bone flap and neuropace neurostimulator and leads.At the time of the event, the neurostimulator was programmed for detection only.The patient was sent home with an infusion of iv antibiotics via picc line.

Manufacturer Narrative

(b)(4).Explanted product received at neuropace and investigation performed.Investigation included inspection of the returned product and review of device history records.There was no indication of product failure or identification of any factors that could have caused or contributed to the reported 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 ; 6502372788
• MDR Report Key: 6800788
• MDR Text Key: 82920651
• Report Number: 3004426659-2017-00036
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170727
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• 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: 23292-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2017
• 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: 37 YR