MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	RNS-300M-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	08/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient was implanted on (b)(6) 2017 immediately following invasive monitoring.Patient was implanted with two leads: cortical strip lead (model cl-325-10) placed in the left frontal motor cortex connected to port 1.Depth lead (model dl-330-3.5) placed in the left hippocampus connected to port 2.In addition to implant with the rns system, the patient underwent a concurrent frontal resection.
Event or Problem Description
Patient reported to the surgeon that she felt leaking from her wound starting approximately the week of (b)(6) 2017, 10 weeks after invasive monitoring which was immediately followed by rns system implant and concurrent resection.No other symptoms were reported.Treatment included surgical intervention to close the wound and lumbar drain to address the csf leak.No cultures were taken; the surgeon did not believe there was an infection but planned to treat the patient prophylactically with antibiotics.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 6868523
• Report Number: 3004426659-2017-00039
• Device Sequence Number: 13781142
• Product Code: PFN
• UDI-Device Identifier: 00855547005137
• UDI-Public: 0100855547005137
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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
• Operator of Device: Physician
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 23602-1-1-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 26 YR