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

Model Number RNS-320-K - FGI

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 315030751
• Report Number: 3004426659-2023-00018
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Male