Sprint Fidelis on A Current Affair

We would strongly urge all patients concerned by the current media coverage of the potential Sprint Fidelis lead fractures to discuss their individual case with their treating physician.

The current media coverage does not relate to a new product hazard alert. The original alert was issued to doctors in October 2007 and several other communications have been made with doctors since then.

Patients should be assured that wherever issues are identified with products, doctors are provided with extensive information and recommendations in order to manage their patients appropriately. In the case of Sprint Fidelis, Medtronic ensured that treating practitioners were promptly provided information to allow them to exercise their clinical judgment as to whether and how to contact their patients about their leads.

Medtronic estimates more than 70,000 lives have been saved by implantable defibrillators over the past five years. Studies have shown ICDs to be 98 percent effective in treating dangerous arrhythmias that can lead to sudden cardiac arrest.