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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Review of the patient's impedance and ecog data was performed, the data is consistent with an intermittent lead break.The explanted lead was not returned to neuropace for analysis, however review of the lead impedance and ecog data was performed and the data is consistent with an lead break.Unable to determine root cause.
Event or Problem Description
The neurologist observed a signal artifact on the ecog signal from the patient's lead connected to port 1 of the neurostimulator, indicating a potential lead break.The artifact was observed/recreated while running a real-time ecog and palpating around the region of the neurostimulator and where the lead was secured via the dog bone plate.The physician then programmed the neurostimulator so the affected lead was no longer part of the therapy pathway.On (b)(6) 2018, a lead revision was performed.Detection and therapy has been restored to both leads.

• 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: 7470071
• Report Number: 3004426659-2018-00013
• Device Sequence Number: 1273389
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417190720
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 22420-1-1-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/27/2018
• 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
• Patient Age: 53 YR