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

Model Number RNS-320-K - FGI

Device Problem Premature Discharge of Battery (1057)

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

Event Date 07/12/2022

Event Type  Injury  

Event 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.

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
• 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
• MDR Report Key: 16769934
• MDR Text Key: 313590468
• Report Number: 3004426659-2023-00016
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717191115
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 27 YR
• Patient Sex: Female