Assessment of the Value of Electronic Health Records Data for Identifying Implantable Cardiac Lead Failures

The primary objective of this study was to examine the feasibility of establishing a generalizable and efficient process for determining medical device reliability. The study specifically focused on implantable leads (i.e., electrodes) for permanent cardiac pacemakers and defibrillators using different data sources, including electronic health record (EHR) data, CMS claims data, device manufacturer databases, and the U.S. Food and Drug Administration (FDA)’s Medical Device Adverse Event Reports (MAUDE) database. The leads examined in this study were Class III devices.

This study sought to ascertain the degree to which existing EHR data can be harnessed to determine device reliability, using cardiac leads as a Test-Case. The study also triangulated several different data sources to examine device reliability to determine the strengths and limitations of these different sources, and further examining the value of PCORnet as a national resource to address a wide range of issues related to medical device safety. Using EHR data, lead failures were determined based on specific procedure codes found in the EHR after the date of implantation.

This study brought together key stakeholders from industry, academia, and the regulatory sphere around a common goal of improving methods for assessing device safety and effectiveness.