Systems used to forecast remaining pacemaker battery service life
|Publication Date:||1 January 2017|
This technical information report describes the clinical expectations for the performance of systems that use "realtime" measurements telemetered by a pulse generator to forecast remaining battery service life. These systems combine the "real-time" measurements with assumptions provided by the clinician to forecast the remaining service life of the pacemaker battery. The method described in this report is based on the use of battery voltage measurements. Other methods that use battery impedance or charge measurements can also be used.
This technical information report discusses the input requirements from both the pulse generator (e.g., battery resistance, etc.) and the clinician regarding usage history and the anticipated use profile.
This report also discusses the practical limitations of forecasting remaining pacemaker battery service life using this type of system. These limitations include those inherent in the pacemaker, such as (a) battery variability, (b) accuracy of the measurement system, and (c) variability in the use profile. The report also discusses the limitations associated with the availability and accuracy of information provided by the clinician.
Guidance on presentation of the resulting information is included to facilitate its use by the clinician as part of a total patient management program.
This report does not cover those algorithms that are used by pacemaker manufacturers for longevity analysis associated with labeling claims. This report is not applicable to implantable cardioverter defibrillators (ICDs).