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 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's first rns system.System implant included rns sn (b)(4) right parietal, two strip leads.Port 1 cl-325-10, sn (b)(4), left subtemporal.Port 2 cl-325-10, sn (b)(4), right subtemporal.

Event Description

Dr.(b)(6) reported to the neuropace field clinical engineer that the patient presented with a surgical site infection, which the patient had ignored at home for several weeks.The neurosurgeon removed the patient's rns neurostimulator and leads on (b)(6) 2017.The patient developed the infection after undergoing a right temporal lobectomy and rns lead revision procedure in (b)(6) 2017.The patient was prescribed iv antibiotics for 6 weeks.The site categorized the infection as deep 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: 6897312
• MDR Text Key: 87487227
• Report Number: 3004426659-2017-00043
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151226
• 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: 09/26/2017

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: 20944-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/27/2017
• 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: 41 YR