Medical devices maker Medtronic Inc. said on Monday it suspended sales of a component to heart devices known as defibrillators, saying the equipment may have contributed to five patient deaths.
Minneapolis-based Medtronic, one of the largest makers of heart devices, said it suspended sales of the Sprint Fidelis line of "leads," which are wires placed on heart muscles and attached to a defibrillator, or an implanted electrical device designed to maintain appropriate heart rhythm.
Medtronic said about 268,000 leads have been implanted worldwide. It said the leads have the potential for fracture.
"Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor," the company said.
It said the Food and Drug Administration plans to issue a statement about the Medtronic decision, probably today.
Medtronic said it is not recommending that patients have the leads removed due to the possibility that patients could sustain injury during any replacement. It said it is contacting some 13,000 physicians worldwide to advise patients on their options.
It said lead fractures may cause "inappropriate shocks and/or loss of output."
Minneapolis-based Medtronic is one of the largest makers of defibrillators and the Sprint Fidelis leads are typically sold with the device, according to company spokesman Rob Clark.
Medtronic does not break out sales for the Sprint Fidelis lead, but Clark said the company generated $726 million in defibrillator sales in the fiscal quarter ended July 31, 2007 in a $6 billion market for such devices. It has about 50 percent of that market, said Clark.
The product suspension is the latest setback for Medtronic, which is already suffering from weaker-than-expected sales of implantable defibrillators, where it competes with Boston Scientific Corp. and St. Jude Medical Inc.
Sales of such devices have declined dramatically since 2005 following a wave of product recalls, mostly by Guidant Corp. which was later acquired by Boston Scientific. The devices stop the heart from racing uncontrollably.
