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

Model Number	DL-344-10-K
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A flat lead signal was observed on the left hippocampal lead, indicative of a lead break.A lead revision was performed to replace the damaged lead.It appears the surgeon secured the lead with two dog bones at the initial implant which may have contributed to the observed 'kink' in the lead.The lead was damaged during the replacement process and was not returned for investigation.A new lead was successfully implanted, replacing the damaged lead.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.

• 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: 17080290
• Report Number: 3004426659-2023-00026
• Device Sequence Number: 17703254
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817250518
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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: DL-344-10-K
• Device Catalogue Number: 1007931
• Device Lot Number: 32510-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 06/07/2023
• 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: 61 YR
• Patient Sex: Female