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	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.The ecog and impedance data are suggestive of a potential lead break.
Event or Problem Description
On (b)(6) 2025, the left mesial temporal lead was determined to have a probable lead break based on ecog review.The lead is secured with a dog bone with lead protection.The lead is attached to the rns neurostimulator placed under the right shoulder.On (b)(6) 2025, the lead was explanted.The surgeon implanted a second rns neurostimulator under the left shoulder and placed two new depth leads in the patient's left hemisphere.The surgeon also added an additional depth lead to the right neurostimulator which was placed in the right hemisphere.Upon explant the lead break was observed to have a clean break of the coils within the lead casing along the body of the lead.The break was not near a point of fixation.The lead will not 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: 22180954
• Report Number: 3004426659-2025-00033
• Device Sequence Number: 18296882
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817270626
• 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: 2024
• 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
• Report Date (Section B): 06/10/2025

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: 1007931
• Device Lot Number: 34454-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/10/2025
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male