Medtronic of Canada Ltd. informs Canadian patients of the recall of Sprint Fidelis leads models 6930, 6931, 6948 and 6949 due to potential conductor fractures.
Sprint Fidelis Leads Class Action
Kim Orr Barristers P.C., together with Rochon Genova LLP, have launched a national class action against Medtronic Inc. and Medtronic of Canada Ltd. seeking damages of $550,000,000.00 for the manufacture and sale of defective Sprint Fidelis leads.
An implantable defibrillator is a device that monitors the heart for rapid, slow or irregular rhythms. When abnormal rhythms are detected, the defibrillator delivers a shock to the heart to return it to a normal rhythm. The shock is delivered to the heart by way of leads, which are small, insulated wires implanted in the heart and connecting it to the defibrillator.
Medtronic, the world's leading manufacturer and seller of heart devices, announced on Sunday, October 14, 2007 that it was recalling its Sprint Fidelis electrical leads because the leads were prone to a defect that caused the leads to malfunction, potentially delivering unnecessary shocks to patients or failing to provide life-saving shocks to patients in need. It is estimated that approximately 268,000 patients have received Sprint Fidelis leads in Canada and elsewhere. By letter dated October 15, 2007, Medtronic notified 13,000 physicians that Sprint Fidelis leads models 6930, 6931, 6948 and 6949 should no longer be implanted due to the defects and requested physicians to return any unused leads to Medtronic. Malfunctioning leads may have contributed to five patient deaths worldwide thus far.
Medtronic has suspended sale of all Sprint Fidelis leads and has recommended that physicians stop implanting the leads. Medtronic is urging patients who have the leads to see their doctors to ensure that their leads have not developed a fracture, which could cause a malfunction.
While the Sprint Fidelis leads may be removed and replaced, if necessary, with an older lead called the Sprint Quattro, Medtronic has advised that it does not have enough Sprint Quattro leads available to replace all of the potentially faulty leads.
Medtronic has been using Sprint Fidelis leads with its defibrillators since 2004 and nearly all Medtronic defibrillators implanted since that time use the leads. Medtronic estimates that between 4,000 and 5,000 people, or about 2.3% of those implanted with the Sprint Fidelis leads, will experience a lead fracture within 30 months of implantation. These patients will require a delicate and dangerous surgical procedure to have their leads replaced.
Sherry Robinson, a 34-year-old resident of Sechelt, British Columbia and the representative plaintiff in the Canadian class action, says she is incredulous that so many defective leads have been implanted in patients. In January of this year, Ms. Robinson's defibrillator delivered 18 successive, unnecessary and painful shocks to her heart. Ms. Robinson immediately underwent surgery to have the leads removed.