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

Model Number	RNS-320-K - FGI
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Review of the device sessions identified the voltage decreases are extreme in magnitude, but the timing of the step decreases matches that of changes in programming that could increase charge expenditure.This would at least explain the timing of the voltage drops.Initial investigation confirmed that the battery was depleted.Pending final investigation results.
Event or Problem Description
The device reached an early end of life after 3.06 years.When reviewing the battery plot, the last portion of the plot looked unusual.The device was replaced on (b)(6) 2023.The device was returned and is in the process of being investigated.
Additional Manufacturer Narrative
(b)(4).Previous results: review of the device sessions identified the voltage decreases are extreme in magnitude, but the timing of the step decreases matches that of changes in programming that could increase charge expenditure.This would at least explain the timing of the voltage drops.Initial investigation confirmed that the battery was depleted.Final investigation results: this device performed normally throughout manufacturing screens and for the first couple years of implant.Then it exhibited an abrupt battery depletion consistent with the damage that was found on the cinco asic.The damage that was found has the appearance of esd although it is unlikely that an esd strike occurred after implant.Root cause could not be determined.
Event or Problem Description
Original report: the device reached an early end of life after 3.06 years.When reviewing the battery plot, the last portion of the plot looked unusual.The device was replaced on (b)(6) 2023.The device was returned and investigated.Investigation results are now available, refer to section h10.

• 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
• MDR Report Key: 16913142
• Report Number: 3004426659-2023-00018
• Device Sequence Number: 6376328
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200909
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 - FGI
• Device Catalogue Number: 1007694
• Device Lot Number: 29141-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/26/2023
• 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: Other
• Patient Age: 20 YR
• Patient Sex: Male