Enhanced Monitoring of Sprint Fidelis Leads Proved Useless
When Medtronic recalled its heart defibrillator with Sprint Fidelis leads in October a study was initiated to enhance monitoring of patients currently using the implantable cardioverter defibrillator (ICD). The study was posted in late February on a website for a doctors group called the Heart Rhythm Society that reported researchers of the Minneapolis Heart Institute Foundation found that the enhanced monitoring proved “relatively ineffective in preventing adverse clinical events.” The heightened monitoring intended to detect failures did little to warn patients of potential trouble with their ICDs. About 268,000 people worldwide have been implanted with Sprint Fidelis leads and so far five deaths have been linked to malfunctions. At the time of the recall, doctors were instructed to reprogram patients’ ICDs so that an alarm would sound when something was wrong. Of the 514 Sprint Fidelis leads implanted at the Heart Institute, 17 failed 11 to 35 months after insertion, according to the study. Twelve patients received inappropriate shocks, and two did not hear the warning alarms. “What the report states is that the monitoring technique for determining when a Sprint Fidelis lead is going to fail is relatively ineffective in preventing adverse clinical events,” like inappropriate shocking, said Dr. Robert Hauser, a cardiologist at the foundation who is known nationwide for tracking safety information concerning heart devices. Overall, enhanced monitoring of the leads did not prevent shocks in two-thirds of the Heart Institute's patients that had Sprint Fidelis, the study says.
