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

Model Number	RNS 320
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the explanted device was discarded by the treating center and not returned to neuropace for investigation.Review of the battery performance - the battery performance of rns-320, sn (b)(4) was investigated.The pdms battery voltage plot shows a rapid and unusual voltage decrease starting around (b)(6) 2021.There is no interrogation data between 10/7/2021 and 2/2/2022.Available data show that stimulation parameters, detection rates and electrode impedances are in the normal range.Battery performance monitoring tools were used to assess this device.They show that, while the charge consumption for the device remained in a normal at around 0.19 to 0.20 milliamp hours per day, the battery voltage was comparatively low starting around (b)(6) 2020, after being implanted for 1.2 years.Starting in (b)(6) 2020, the battery voltage was in the bottom 5th percentile for rns-320 devices with similar cumulative charge expenditure for 9 of 11 months before it reached eos.This data supports an interpretation of premature eos for the device.Neuropace was unable to determine the cause of the early battery depletion based on device data analysis.
Event or Problem Description
The neurostimulator was replaced on (b)(6) 2022 for an unexpected end of life.The battery plot voltage was observed to deplete prematurely.Investigation of the neurostimulator data support an interpretation of premature early end of service for the device.After explant the treating center discarded the device.

• 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 ; 6502382788
• MDR Report Key: 14283327
• Report Number: 3004426659-2022-00007
• Device Sequence Number: 4874702
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200605
• 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: 2022
• 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): 05/02/2022

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
• Device Catalogue Number: 1007694
• Device Lot Number: 28458-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Female