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); Unspecified Infection (1930)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2016 rns system implant including three cortical strip leads (cl-325).The leads were placed in the left temporal region.

Event Description

Rns system explanted to treat infection.Infection details not available.

Manufacturer Narrative

(b)(4).Patient presented <30 days after initial implant.Infection was classified as a superficial incisional, deep incisional and sub-dural infection.Described as left cranial wound dehiscence.Patient presentation - patient was awake and oriented, cranial nerves were intact, no neurological deficit was observed.Swab culture was positive for p.Aeruginosa.Treatment included a partial explant on (b)(6) 2016 (rns and left temporal leads) followed by a second explant of the right temporal lead on (b)(6) 2017, antibiotics included ceftazidime and ciprofloxacin.Not returned.

Event Description

New information 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: 6226284
• MDR Text Key: 63971737
• Report Number: 3004426659-2016-00036
• 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,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• 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: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• 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: 31 YR