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Oct. 15, 2007 -- The FDA today urged heart patients to consult a doctor if they have a Medtronic Sprint Fidelis defibrillator lead.
Defibrillators are implanted heart devices that shock dangerous abnormal heart rhythms back to a normal rhythm. The lead is a wire that connects the defibrillator to the heart.
Medtronic has identified five patients whose deaths may have been related to a fractured Sprint Fidelis defibrillator lead.
Medtronic has voluntarily suspended distribution of its Sprint Fidelis defibrillator leads. More than 268,000 Medtronic Sprint Fidelis leads have been implanted worldwide, according to Medtronic.
"We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information," Medtronic President and CEO Bill Hawkins says in a Medtronic news release.
Medtronic's decision is in the "best interest of patient safety," says the FDA's Daniel Schultz, MD, in an FDA news release.
Schultz directs the FDA's Center for Devices and Radiological Health.
The FDA considers Medtronic's action a recall of the Sprint Fidelis leads. But the FDA isn't recommending removing the recalled leads.
"We recognize that some patients and health care professionals might inappropriately interpret the word 'recall' to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed," states the FDA in the news release.
The leads continue to function properly in the "vast proportion of patients," states the FDA.
There is no test to predict which leads will fail.
The FDA agrees with Medtronic's recommendation that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor.
Doing so may increase the likelihood that a fractured lead will be detected before a patient is harmed, according to the FDA.
Doctors should "weigh the risks and benefits of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model," states the FDA.
A small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic.
The FDA recommends that if patients have reason to believe that they have a Sprint Fidelis lead or they don't know the model of their lead, they should contact their health care professional.
The recall doesn't include Medtronic pacemakers.
For more information, call Medtronic at (800) 551-5544 ext. 41835 or visit the company's Sprint Fidelis lead recall?web site.