The Sprint Fidelis story: where are we now?

摘要

Implantable cardioverter-defibrillator (ICD) leads have a : -well-recognized risk of failure. However, the recent experience with lead and generator recalls and market withdrawals has led to a highly critical examination of lead and generator performance, and questions about device reliability have become much more frequent from patients.In October 2007, Medtronic voluntarily stopped selling its Sprint Fidelis ICD lead after observing an abnormally high rate of lead failure. A total of approximately 268,000 Fidelis leads have implanted in patients throughout the world, the majority in the United States. Since the initial removal of the Sprint Fidelis lead from the market, the body of literature documenting the problems with the Fidelis lead has grown. Two recent reports and accompanying editorials in Heart Rhythm have added to our understanding of the problem.An accelerating risk of lead fracture has consistently been found and is borne out in the current study by Hauser and Hayes in this issue of Heart Rhythm?