Sudden Death in Patients With Cardiac Implantable Electronic Devices

Abstract

More than 3 million people in the United States have a permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD).¹ These devices have saved the lives of innumerable patients and have improved the lives of many more. Currently, surveillance for cardiac implantable electronic device (CIED) malfunctions is based on the US Food and Drug Administration–mandated Manufacturer and User Facility Device Experience (MAUDE) database,² which is mandatory for manufacturers but voluntary for health care professionals. Food and Drug Administration adverse event reporting regulations require that manufacturers and facilities such as hospitals report when they learn that a device may have caused or contributed to a death or serious injury (21 CFR §803). Quiz Ref ID Events in deceased patients are not excluded; however, because more than 90% of sudden cardiac deaths (SCDs) occur outside of the hospital³ and because investigation after such sudden deaths is not a routine medical examiner or coroner practice, interrogations and autopsies of SCDs with pacemakers and ICDs are rarely performed.⁴ Deaths in those with CIEDs that occur outside of care facilities or that are unknown to the manufacturer are at particularly high risk to be uninvestigated or unreported to the Food and Drug Administration MAUDE database, and rates of CIED failure that lead to sudden death are unknown. We sought to determine causes of SCDs with CIEDs in an ongoing prospective autopsy study of all incident SCDs in San Francisco, California.