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

Model Number	1007603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/26/2017
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.Continued use.
Event or Problem Description
Onset occurred (b)(6) 2017, 2 days after rns system implantation with concurrent cortical resection.The neurosurgeon reported that the patient was unresponsive and presented with acute neurological decline.Patient was found to have a subdural hematoma located para the area of the cortical resection and underwent emergent surgical decompression.Cause was identified as a leak from cortical arterial vesicle.Patient was noted to have an anomalous cortical architecture.No rns system product was explanted in response to the event.

• 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: 6658962
• Report Number: 3004426659-2017-00025
• Device Sequence Number: 19205309
• 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): 06/16/2017

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: 1007603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/21/2017
• 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