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

Model Number	RNS-320-K
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The treating doctor reported that the patients rns device had reached an early end-of-life after 4.05 years.The device settings were not unusual and did not account for the rapid battery depletion.The device was replaced on (b)(6) 2024.Evaluation of the battery plot identified that the rns device's battery was in the bottom 5th percentile of battery voltage relative to battery discharge for most of its life.The cause is unable to be determined by this investigation.The device will be returned to neuropace for investigation of the actual device.
Additional Manufacturer Narrative
(b)(4).Pending return of the explanted device.
Additional Manufacturer Narrative
(b)(4).Investigation of the returned device.Interrogation data taken during the implant service life of this device strongly supports the hypothesis that the battery life was shorter than it should have been given the estimated battery capacity delivered based on interrogation data.Possible causes of an early battery depletion include an abnormally high therapy load (it was noted that the patient's programming included long burst duration), a circuit failure, or an underperforming battery.These possibilities were investigated and no root cause for this failure was able to be determined.
Event or Problem Description
Investigation results provided in h10.The treating doctor reported that the patients rns neurostimulator device had reached an early end-of-life (eol) after 4.05 years.The device settings were not unusual and did not account for the rapid battery depletion.The device was implanted on (b)(6) 2020 and replaced on (b)(6) 2024.Evaluation of the battery plot identified that the rns neurostimulator's battery was in the bottom 5th percentile of battery voltage relative to battery discharge for most of its life.The cause is unable to be determined by this investigation.The device will be returned to neuropace for investigation of the actual 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 ; 5108822607
• MDR Report Key: 19658785
• Report Number: 3004426659-2024-00044
• Device Sequence Number: 17779503
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201120
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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-K
• Device Catalogue Number: 1007694
• Device Lot Number: 29548-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 01/27/2025
• 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; Other
• Patient Age: 21 YR
• Patient Sex: Female