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

Model Number	DL-330-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The ecog and impedance data are suggestive of a potential lead break.Neuropace was unable to determine a root cause.The explanted product was not returned to neuropace, inc.
Event or Problem Description
Based on the review of the patient's ecogs by the treating center, a signal artifact was identified on the right depth lead indicating a potential lead break.Per the treating center, the patient fell due to a seizure in may 2018 and hit her head which is felt to be the probable cause of the possible lead break.The patient does not frequently interrogate and synchronize her neurostimulator and therefore this issue was not identified until (b)(6) 2018.During a routine neurostimulator replacement on (b)(6) 2018, the lead with the signal artifact was explanted and a new lead was implanted and connected to the rns neurostimulator.

• 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: 8064549
• Report Number: 3004426659-2018-00046
• Device Sequence Number: 16759893
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517171218
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 19506-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 11/13/2018
• 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: 37 YR