The returned ipg was received at the eos state.The data log analysis revealed that the ipg reached eri at timestamp 1694869337 (approx.(b)(6) 2023), and the eos happened at 2 years, 6 months, and 23.5 days after the initial active programming.The average energy use index (eui) was 14.The ipg exhibited normal characteristics during the visual and functional examination.A product labeling review identified that the device was used per the instructions for use (ifu) product label and it did not reveal any anomalies.The ifu states that when the implanted non-rechargeable stimulator is nearing the end of its battery life, the stimulator will enter the elective replacement mode.The elective replacement indicator (eri) will appear on the remote control and clinician programmer.Stimulation is still being provided during this eri period.Changes made to the stimulation will not be saved, and stimulation will not be available soon.Patients should be advised to contact their healthcare provider to report this message screen.The stimulator must be replaced to continue receiving stimulation.Batteries that have lasted 12 months or more without entering eri mode will have a minimum of 4 weeks between entering eri mode and reaching the end of battery life.Surgery is required to replace the implanted non rechargeable stimulator.When the stimulator battery is fully depleted, the end of service (eos) indicator will be displayed on the remote control and clinician programmer.Stimulation will not be available.Surgery is required to replace the implanted non-rechargeable stimulator to continue providing stimulation.Based on all available information, the reported event of the patient experiencing loss of stimulation and not receiving an elective replacement indicator (eri) message before the end of service (eos) of the implantable pulse generator (ipg) could not be confirmed through device analysis.The ipg did not reveal any signs of premature battery depletion.However, the labeling indicates that batteries that have lasted 12 months or more without entering eri mode will have a minimum of 4 weeks between entering eri mode and reaching the end of battery life.Stimulation is still being provided during this eri period.It is most likely that the user was not aware of the eri message when it was displayed on the remote control.It was also reported that the patient was no longer receiving stimulation.The labeling states that when the stimulator battery is fully depleted, the eos indicator will be displayed and stimulation will not be available at this time.Therefore, it was determined that no problem was detected with the device.
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