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

Model Number	DL-344-3.5-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
On (b)(6) 2024, the epileptologist first identified signal artifact and high impedance on the left insula depth lead.At that time, lead detection was modified on the lead.There is no indication as to the cause of the probable lead break.On (b)(6) 2024, the patient underwent replacement of the lead.During the replacement procedure, the connector cover was inspected, cleaned out and re-tested.Upon evaluation of the lead at the entry point into the skull, it was noted that the lead had a sharp bend when exiting the dog-bone plate, which could have been where a fracture occurred.Neuropace is pending information which would indicate if the lead will be returned.

• 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: 20622152
• Report Number: 3004426659-2024-00071
• Device Sequence Number: 7534301
• Product Code: PFN
• UDI-Device Identifier: 00855547005021
• UDI-Public: 010085554700502117211108
• 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: 2021
• 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): 11/06/2024

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-344-3.5-K
• Device Catalogue Number: 1007606
• Device Lot Number: 27038-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• 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: Hospitalization; Other
• Patient Age: 31 YR
• Patient Sex: Male