Medtronic maker of the now recalled Sprint Fidelis lead is changing its manufacturing lines to the Sprint Quattro. The product suspension is the latest setback for Medtronic which last month said it planned to cut 500 jobs from the cardiac rhythm management part of the business.Medtronic generates revenues of about $12.3 billion and employs over 37,000 people worldwide. It owns 50 percent of the implantable cardioverter defibrillator (ICD) market. The company's shares sank 12 percent.
The Sprint Fidelis line of leads is an insulated wire that links the heart to an ICD, a lifesaving heart device that can shock a racing heartbeat back to normal rhythm.
Medtronic said the leads have a small increased risk of fracture and recommended that patients not have them removed due to the possibility of injury during any replacement -- advice endorsed by the U.S. Food and Drug Administration.
Instead, patients should see their doctors to have their ICDs reprogrammed to better monitor for the potential of a lead to fracture. About 268,000 of the leads have been implanted worldwide.
The Sprint Fidelis leads were developed as a thinner, more flexible alternative to Medtronic's older but more reliable, model Sprint Quattro leads.
Medtronic generated $726 million in defibrillator sales during the fiscal first quarter.
