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

Model Number RNS 320

Device Problem Premature Discharge of Battery (1057)

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

Event Date 04/04/2022

Event Type  malfunction  

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 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
• 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 ; 6502382788
• MDR Report Key: 14283327
• MDR Text Key: 299594800
• Report Number: 3004426659-2022-00007
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200605
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Female