Abstract 119: Using the VA National Cardiac Device Surveillance Program to Monitor the Safety of Cardiovascular Implantable Electronic Devices

Background: Hundreds of thousands of cardiovascular implantable electronic devices (CIEDs: pacemakers and implantable-cardioverter-defibrillators [ICDs]) have been the subject of Class 1 FDA recalls, which indicate “a reasonable chance that a product will cause serious health problems or death.” Unfortunately, these recalls occurred only after many patients had experienced adverse events. The Department of Veterans Affairs (VA) has established the VA National Cardiac Device Surveillance Program (VANCDSP), a prospective registry that provides remote monitoring surveillance of enrolled veterans with CIEDs. Objective: To describe the characteristics of veterans enrolled in the VANCDSP between 2002 - 2018 and the prevalence of CIED recalls among currently monitored patients. Methods: We queried the VANCDSP and used descriptive statistics to summarize the characteristics of patients, use of remote monitoring, and prevalence of recalls or alerts for CIED generators and leads. Patient and device characteristics ...