October 16, 2007 – Medtronic Inc. said in a statement that it has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures, and the company recommends that physicians do no perform new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949).
The Sprint Fidelis leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. This action does not affect Medtronic pacemaker patients.
Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis.
This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Based on Medtronic’s extensive performance data, Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro lead at 30 months (97.7 percent Sprint Fidelis vs. 99.1 percent Sprint Quattro). This difference is not statistically significant; however, if the current lead fracture rates remain constant, it will become so over time. Medtronic believes that given this performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest.
Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output. Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.
The FDA intends to issue a public statement regarding Medtronic’s decision at www.fda.gov.
In conjunction with Medtronic’s Independent Physician Quality Panel, Medtronic communicated, via letter and direct outreach with more than 13,000 physicians worldwide, the Sprint Fidelis lead performance data and updated patient management recommendations for patients who are implanted with Sprint Fidelis leads. These recommendations include device programming and patient management recommendations that will ensure a patient’s device is set to more effectively monitor for potential problems and provide an audible alert in the event of lead fractures.
For more information: www.medtronic.com/fidelis