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

Model Number	DL-344-10-K
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): the explanted lead was not returned to neuropace for analysis.However, review of the device ecog and lead impedance confirmed that the ecog data are suggestive of a potential lead break.
Event or Problem Description
A change in the left depth lead impedance and signal was observed in (b)(6) 2017 during remote review of the patients ecogs and confirmed in (b)(6) 2018 during a patient appointment.At the appointment, the decision was made to disable detection on this lead.No information regarding seizure-related trauma or other potential causal factors resulting in the lead break were provided by the treating center.During a routine battery replacement on (b)(6) 2019, the depth lead was removed and a new lead was implanted and connected to the neurostimulator without complications.The explanted lead was damaged during the removal process and was discarded by pathology.

• 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: 8335464
• Report Number: 3004426659-2019-00003
• Device Sequence Number: 2321593
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417180910
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 21075-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/13/2019
• 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: 34 YR