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Distribution of Sprint Fidelis defibrillation leads is suspended by Medtronic

Medtronic : 15 October, 2007  (New Product)
Medtronic has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for the leads to fracture.
In addition, the company recommends against 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, MD, 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 SprintFidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture.

The 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).

The 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.

“There is nothing more important to us than the safety and well-being of patients,' said Bill Hawkins, president and chief executive officer of Medtronic. 'We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information.'

In conjunction with Medtronic's Independent Physician Quality Panel, Medtronic has 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.

The 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.

'Medtronic has acted responsibly to address concerns about the possibility of lead fractures and to minimise harm to patients,' said Kevin Hackett, MD of Columbus Cardiology Consultants and member of Medtronic's Independent Physician Quality Panel. 'The Physician Panel has reviewed Medtronic's data and believes they are taking the correct action.'
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