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

Model Number	DL-330-10-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	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), investigation of the ecog and impedance data are suggestive of a potential lead break.The lead that was returned was damaged during the explant process.Neuropace was unable to confirm the actual lead break.
Event or Problem Description
On (b)(6) 2024, during the patient's clinic visit, a possible lead break was identified.The team was unable to perform an impedance measurement on contact 2 of the left mesial temporal depth lead.Impedances were measured and there was an impedance alert on contact 2 of the lead.A change in programming was made by turning off contact 2 and programmed contacts 1, 3, and 4.On (b)(6) 2024, the lead was replaced and the explanted lead will be returned to neuropace for investigation.Note: the explanted lead was damaged during the explant process.

• 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: 20821376
• Report Number: 3004426659-2024-00075
• Device Sequence Number: 8843224
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517230611
• 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: 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): 12/02/2024

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: 30012-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/02/2024
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female