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

Model Number	CL-325-10-K - FGI, LEADS, CL-325-10-K
Medical Device Problem Codes	Under-Sensing (1661); Missing Value Reason (3192)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pending product return for further investigation.The patient is currently implanted with the rns system and is programmed for detection and treatment.The patient was not adversely affected by this event.Pending product return.
Event or Problem Description
During the case, there was no real time ecog signal observed on contacts 1 & 2 of the cortical strip lead connected to port 1.Troubleshooting was performed and the lead was moved to other locations on the cortical surface of the brain with no real time ecog signal observed.The lead was then cleaned and placed in port 2 to confirm lead vs neurostimulator issue and with the same result of no signal observed on contacts 1 and 2.Other leads that were implanted were connected and we observed good recording throughout the system.The neurosurgeon removed the cortical strip lead in question and implanted a new cortical strip lead.All contacts on this new lead recorded properly.
Additional Manufacturer Narrative
Comp-(b)(4).No malfunction was observed.Unable to duplicate reported failure.The lead was returned to neuropace for investigation.There were no noticeable deformations or damage to: the lead body, coil, welds, electrode, or contacts.No gaps were observed in the coil.There was some bending of the lead which is most likely a result of the implant process.Continuity testing passed on all four channels.Impedance testing passed all four channels.Observed a 'kink' in the polyimide between the second and third contacts - this did not affect lead electrical performance and is most likely due to manipulation after implant.
Event or Problem Description
New information (b)(6) 2016 presented.

• 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: 6150953
• Report Number: 3004426659-2016-00033
• Device Sequence Number: 18845131
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917181119
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: CL-325-10-K - FGI, LEADS, CL-325-10-K
• Device Catalogue Number: 1007609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 12/15/2016
• 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: Required Intervention
• Patient Age: 23 YR