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

Model Number	RNS-320-K - FGI
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The rns neurostimulator (model rns-320) reached end of life (eol) 3.3 years after initial implant (b)(6) 2019.Battery life expectancy is usually 6.0 - 12.4 years with typical use.With medium stimulation and detection settings the battery is estimated to last 10.8 years.The patient underwent a neurostimulator replacement on (b)(6) 2022.The device was returned and investigated by neuropace.When compared to expected battery plot behavior, the battery plot curve of the explanted device was observed to be discharging at an abnormally fast rate.The shape of the discharge curve was normal, except for downward spikes.
Additional Manufacturer Narrative
The rns neurostimulator (model rns-320) reached end of life (eol) 3.3 years after initial implant (b)(6) 2019.Battery life expectancy is usually 6.0 - 12.4 years with typical use.With medium stimulation and detection settings the battery is estimated to last 10.8 years.The patient underwent a neurostimulator replacement on (b)(6) 2022.The device was returned and investigated by neuropace.When compared to expected battery plot behavior, the battery plot curve of the explanted device was observed to be discharging at an abnormally fast rate.The shape of the discharge curve was normal, except for downward spikes.

• 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
• MDR Report Key: 16769934
• Report Number: 3004426659-2023-00016
• Device Sequence Number: 17751530
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717191115
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 - FGI
• Device Catalogue Number: 1007694
• Device Lot Number: 27149-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 27 YR
• Patient Sex: Female