Related manufacturer report number 2017865-2023-20886.It was reported that the programmer exhibited an incorrect longevity estimate because of a battery longevity calculation overestimation.It is unknown if the programmer was running the updated software version at the time the longevity discrepancy was discovered.The patient¿s pulse generator was explanted, however, it is unknown if the device had reached elective replacement indicator (eri) level.No patient complications have been reported as a result of this event.
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Additional information was received indicating that during a follow up in clinic in june 2022, the device was found with battery voltage at elective replacement indicator (eri) level.At the previous interrogation, in february 2022, the longevity estimation on the battery was 9.2 months.Longevity overestimation was suspected to have occurred due to the programmer at the previous follow up in clinic.The device was explanted and replaced after reaching eri level due to normal battery depletion.The patient was in stable condition.
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