Fracture prediction of cardiac lead medical devices using Bayesian networks

•A new method to simulate the fatigue experience of an implanted cardiac lead.•Fatigue strength and use conditions are incorporated within a Bayesian network.•Confidence bounds reflect the uncertainty in all input parameters.•A case study is presented using market released cardiac leads.

A novel Bayesian network methodology has been developed to enable the prediction of fatigue fracture of cardiac lead medical devices. The methodology integrates in-vivo device loading measurements, patient demographics, patient activity level, in-vitro fatigue strength measurements, and cumulative damage modeling techniques. Many plausible combinations of these variables can be simulated within a Bayesian network framework to generate a family of fatigue fracture survival curves, enabling sensitivity analyses and the construction of confidence bounds on reliability predictions.The method was applied to the prediction of conductor fatigue fracture near the shoulder for two market-released cardiac defibrillation leads which had different product performance histories. The case study used recently published data describing the in-vivo curvature conditions and the in-vitro fatigue strength. The prediction results from the methodology aligned well with the observed qualitative ranking of field performance, as well as the quantitative field survival from fracture. This initial success suggests that study of further extension of this method to other medical device applications is warranted.