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

Model Number	RNS-320-K
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	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a review of the patient's device data, it was identified the battery was at 2.35v after 3.5 years.The settings are relatively standard settings.This appears to be an early battery depletion.No defects were identified during the production of the device, it has been manufactured and released per our specifications.Review of the device battery behavior: the device appears to be in the bottom 5th percentile of battery voltages compared to other batteries with similar charge expenditures for its entire history.This is unusual and may be indicative of premature battery depletion.The device has been requested to be returned for investigation.
Additional Manufacturer Narrative
(b)(4).Pending return of the device for investigation.
Additional Manufacturer Narrative
(b)(4).The explanted device was returned and investigated.Investigation results - this device exhibits high current drain only when the stimulation multiplier (stim mult) is active which is consistent with the accelerated battery drain.Thermal imaging shows behavior consistent with electrical overstress to the stimulation output stage (sdac).Neuropace was unable to determine the cause or source of the electrical overstress.
Event or Problem Description
Investigation results presented in section h10 during a review of the patient's device data, it was identified the battery was at 2.35v after 3.5 years.The settings are relatively standard settings.This appears to be an early battery depletion.No defects were identified during the production of the device, it has been manufactured and released per our specifications.Review of the device battery behavior: the device appears to be in the bottom 5th percentile of battery voltages compared to other batteries with similar charge expenditures for its entire history.This is unusual and may be indicative of premature battery depletion.The device has been requested to be returned for investigation.

• 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: 18896076
• Report Number: 3004426659-2024-00017
• Device Sequence Number: 7589028
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200627
• 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: 2024
• 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): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 28458-1-1-1
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 36 YR
• Patient Sex: Male