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

Model Number	DL-330-10-K
Medical Device Problem Codes	High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).3004426659-2021-00009 / (b)(4).Review of the lead impedance and ecog data was performed and the data is consistent with a lead break.The explanted product was not returned to neuropace for analysis.
Event or Problem Description
A routine data review of the patient's data in pdms indicated that the lead connected to port 1 demonstrated artifact and insufficient charge during impedance measurement, suggestive of a lead break.On (b)(6) 2019, detection was disabled for the lead in port 1 and the patient continued to receive treatment via the lead connected in port 2.In (b)(6) 2020 it was noted via a review of the patient's data in pdms that the lead connected to port 2 also began demonstrating intermittent artifact, although impedances were within the normal range, suggestive of a lead break.Once the second break was noted, the patient was scheduled for a surgical procedure to replace both leads connected to the rns neurostimulator.Upon explant, a break was visibly apparent in both leads, the leads were kinked at the point they were anchored to the skull via a dog-bone plate (non-neuropace product).No complications were reported during the surgical procedure and the patient is currently receiving treatment with the rns system.

• 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: 11441117
• Report Number: 3004426659-2021-00008
• Device Sequence Number: 4048528
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517211108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 27037-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/08/2021
• 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: Other
• Patient Age: 49 YR