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

Model Number	RNS-320-K
Medical Device Problem Codes	Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was seen in clinic on (b)(6) 2025 for a routine visit.Patient reported that she was unable to download or communicate with her device.During the clinic visit the provider confirmed that the device was not communicating.The programmer used to interrogate the device was confirmed to be in proper working order by use on other devices successfully.There was no report of a procedure or trauma that could have resulted in an unresponsive device.
Additional Manufacturer Narrative
(b)(4) review of the ecog data did not identify a reason for the neurostimulator to stop communicating.The device was returned to neuropace is undergoing investigation.
Event or Problem Description
Investigation results: investigation of the explanted neurostimulator has been completed and results are provided in section h10.Original report: the patient was seen in clinic on (b)(6) 2025 for a routine visit.Patient reported that she was unable to download or communicate with her device.During the clinic visit the provider confirmed that the device was not communicating.The programmer used to interrogate the device was confirmed to be in proper working order by use on other devices successfully.There was no report of a procedure or trauma that could have resulted in an unresponsive device.
Additional Manufacturer Narrative
(b)(4).Review of the ecog data did not identify a reason for the neurostimulator to stop communicating.Investigation of the explanted device: the neurostimulator was implanted on (b)(6) 2019.The therapy load was higher than typical until it was reduced to a more typical level in (b)(6) 2025.The therapy load is not believed to be related to the device failure.The device did not respond to telemetry over the date range of (b)(6) 2025 to (b)(6) 2025, although the device did continue to function and deliver therapy during this time.The device logged a dc leak reset the same day as the explant on (b)(6) 2025, possibly due to esu exposure.Telemetry was and continues to be functional after explantation.Once explanted, the device was fully functional, it passes all manufacturing screens.The cause of the temporary telemetry failure is unknown.

• 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: 23482686
• Report Number: 3004426659-2025-00073
• Device Sequence Number: 18519203
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200417
• 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: 2019
• 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): 12/01/2025

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: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 28105-1-1-1
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 64 YR
• Patient Sex: Female