RELIABILITY SYSTEMS FOR IMPLANTABLE CARDIAC DEFIBRILLATOR BATTERIES

The reliability of the power sources used in implantable cardiac defib rillators is critical due to the life-saving nature of the device. Ach ieving a high reliability power source depends on several systems func tioning together. Appropriate cell design is the first step in assurin g a reliable product. Qualification of critical components and of the cells using those components is done prior to their designation as imp lantable grade. Product consistency is assured by control of manufactu ring practices and verified by sampling plans using both accelerated a nd real-time testing. Results to date show that lithium/silver vanadiu m oxide cells used for implantable cardiac defibrillators have a calcu lated maximum random failure rate of 0.005% per test month.