Medtronic of Canada Ltd. (Medtronic) in consultation with Health Canada

Medtronic of Canada Ltd. (Medtronic) in consultation with Health Canada is advising patients that it has voluntarily suspended the distribution of the Sprint Fidelis defibrillation leads (models 6930, 6931, 6948, 6949). Sprint Fidelis leads are thin wires that connect a defibrillator implanted near the shoulder to your heart.

Medtronic has informed your doctor that there is a small chance of fractures in particular locations on the lead and has advised doctors to stop implanting the leads and return the unused products to the firm.

Lead fractures could cause the defibrillator to deliver unnecessary shocks or, in very rare instances, to fail to deliver a shock. If you have one of the affected leads, your Patient ID card should contain one of the following four sets of numbers: 6930, 6931, 6948, and 6949, shown at the beginning of a longer set of numbers on your ID card. You will be contacted directly by your doctor for follow-up. Your doctor may choose to change the way your device is programmed to help reduce any potential problems.

The suspension of distribution does not require your Sprint Fidelis Lead to be removed and replaced, because the risk of removal in most patients exceeds the small risk of lead fractures. In consultation with your doctor, you can decide what is best for you.

Sprint Fidelis Leads have been available in Canada since July 2004. Medtronic's decision to suspend distribution of the Sprint Fidelis Leads was made following a review of recommendations by an Independent Physician Quality Panel. As of October 4, 2007, approximately 268,000 Sprint Fidelis Leads have been implanted worldwide.

Medtronic is aware of five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. None of these deaths are in Canada.