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	Convulsion/Seizure (4406)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation of the patient ecogs and the stimulation path impedance.The review of the patient data was consistent with a potential lead break.The explanted product was not returned for investigation.
Event or Problem Description
The patient was admitted to the emergency medical unit on (b)(6) 2024 after reporting worsening of seizures.When reviewing the patient ecog data: signal artifact, impedances, and tilt alert were observed on the right occipital depth lead.Troubleshooting included palpation of the lead connection, while monitoring ecog changes.The first potential artifact spiking appeared on (b)(6) 2024 in a scheduled ecog on channel four (4).The first clear and obvious flattening/ artifact signal was observed on (b)(6) 2024.The cause was not identified.The lead was secured with a dog bone and lead protection.The lead was replaced on (b)(6) 2025.
Event or Problem Description
Refer to investigation results in section h10.Original report - the patient was admitted to the emergency medical unit on (b)(6) 2024 after reporting worsening of seizures.When reviewing the patient ecog data: signal artifact, impedances, and tilt alert were observed on the right occipital depth lead.Troubleshooting included palpation of the lead connection, while monitoring ecog changes.The first potential artifact spiking appeared on (b)(6) 2024 in a scheduled ecog on channel four (4).The first clear and obvious flattening/ artifact signal was observed on (b)(6) 2024.The cause was not identified.The lead was secured with lead protection and a dog bone.The lead was replaced on (b)(6) 2025.
Additional Manufacturer Narrative
(b)(4).Evaluation of the patient ecogs and the stimulation path impedance.The review of the patient data was consistent with a potential lead break.The explanted lead was returned to neuropace for investigation.The lead was visually inspected upon receipt.Crushing damage was observed 19cm from the proximal end.The damage is consistent with damage that can result from the use of a dog bone clamp.

• 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: 21390001
• Report Number: 3004426659-2025-00004
• Device Sequence Number: 8292452
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517260123
• 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: 2025
• 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,Followup
• Report Date (Section B): 05/12/2025

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: 1007929
• Device Lot Number: 33053-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 05/12/2025
• 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; Other
• Patient Age: 15 YR
• Patient Sex: Female