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

Model Number RNS-320-K

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

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

Event Date 02/14/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

(b)(4).Pending return of the device for investigation.

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 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
• 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 ; 5108822607
• MDR Report Key: 18896076
• MDR Text Key: 337575075
• Report Number: 3004426659-2024-00017
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200627
• 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,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 36 YR
• Patient Sex: Male