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 Problem Unspecified Infection (1930)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient underwent rns system implant along with a concurrent right medial frontal resection immediately following 7 days of invasive intracranial monitoring.The patient was implanted with the rns neurostimulator and four cortical strip leads (port 1, cl-325 sn (b)(4), right frontal, not connected, cl-325, sn (b)(4), right frontal, not connected, cl-325, sn (b)(4), right frontal, port 2, cl-325, sn (b)(4), right frontal) and the procedure duration was approximately 9 hours.

Event Description

The patient was seen in the emergency room (er) on (b)(6) 2017 reporting a fever, nasal congestion, and cough.Er personnel thought this to be viral and therefore no antibiotics were started.The patient returned to er on (b)(6) 2017 with same complaints and again no treatment was administered.Patient was then seen by the neurosurgeon on (b)(6) 2017 who performed an aspiration of the right subgaleal swelling which was purulent in nature.The patient was admitted for surgery to remove the bone flap, rns neurostimulator and all 4 cortical strip leads.The infection was categorized by the treating center as superficial incisional.

• 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: 6927134
• MDR Text Key: 88834225
• Report Number: 3004426659-2017-00045
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017171109
• 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: 10/06/2017

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: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 23658-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/07/2017
• 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: 13 YR