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

Model Number	1007607
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device not returned.
Event or Problem Description
Patient had initial implant of the rns system on (b)(6) 2016.Patient was implanted with rns neurostimulator and two depth leads both implanted within the right frontal cortex.Approximately 2 weeks post op, patient developed a new seizure type and left side weakness.Patient was admitted to the hospital and received a ct scan and results revealed intra-cranial swelling at the site of superior depth lead located in the right frontal cortex.Infection, stroke and meningitis were ruled out by lab work-up and imaging.Patient was started on a course of iv steroids in an effort to reduce swelling at the superior depth lead site.On (b)(6) 2016 patient was taken to the or for removal of superior right frontal depth lead as swelling did not decrease significantly.Patient's neurostimulator and inferior right frontal depth lead remain implanted.Patient was discharged from the hospital on (b)(6) 2016 and was transferred to an acute rehab facility due to lack of patient support at home.

• 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: 5884202
• Report Number: 3004426659-2016-00021
• Device Sequence Number: 19125603
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417180120
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: 1007607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/17/2016
• 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: 62 YR