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

Model Number	CL-335-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an ecog review performed on 08/09/2022, an unusual signal was observed, indicative of a lead break on the right sub-temporal strip.The break appears to have occurred around feb 2022.There was no change in treatment, the doctor reported that the fracture did not seem to affect efficacy of the rns system.Troubleshooting included palpitation of the lead which resulted in high impedance and signal artifact.No known trauma was reported, and a cause was unable to be determined.The lead was secured with a burr hold cover.The lead has been implanted 1.7 years at time of lead break observation.On (b)(6) 2023 the patient underwent a lead revision.
Additional Manufacturer Narrative
(b)(4).The lead remains implanted but disconnected from the rns.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 16769935
• Report Number: 3004426659-2023-00015
• Device Sequence Number: 6436889
• Product Code: PFN
• UDI-Device Identifier: 00855547005304
• UDI-Public: 010085554700530417230226
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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
• Device Model Number: CL-335-10-K
• Device Catalogue Number: 1007934
• Device Lot Number: 29716-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male