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

Model Number	DL-330-10-K
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pre-clinic review of the patient's ecog it was observed that there were some ecogs that have artifact that is often associated with lead fractures.There was an observed change to flat signal on the lead interspersed with high amplitude artifact.Palpation of lead (right depth lead, secured with a dog bone with lead protection) leading to signal change on live ecog was performed and confirmed the activity.The physician removed detection and stimulation from the affected lead.It is unknown what caused or contributed to the lead break.The lead was replaced on (b)(6) 2024.
Additional Manufacturer Narrative
(b)(4).Pending return of the explanted device for investigation.

• 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: 19093352
• Report Number: 3004426659-2024-00033
• Device Sequence Number: 20788476
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517260801
• 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: 2023
• Device Explanted Year: 2024
• 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): 04/09/2024

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-330-10-K
• Device Catalogue Number: 1007929
• Device Lot Number: 33545-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female