by Dane Hamilton
Last Updated: 2007-10-15 16:49:46 -0400 (Reuters Health)
NEW YORK (Reuters) – Medical device maker Medtronic Inc. said on Monday it has suspended sales of a defibrillator component, saying the equipment may have contributed to five patient deaths.
Minneapolis-based Medtronic, one of the largest makers of heart devices, said it halted sales of the Sprint Fidelis line of leads. About 268,000 of these leads have been implanted worldwide.
"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.
The company is not recommending that patients have the leads removed because of 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.
Lead fractures may cause "inappropriate shocks and/or loss of output," the company said.
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 that the company has about 50 percent of the market.
Medtronic 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.
Medtronic said last month it planned to cut some 500 jobs from its cardiac rhythm management business, which makes implantable cardioverter defibrillators.