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On October 15, 2007, Medtronic, Inc., the nation's largest maker of implanted heart devices, announced the market withdrawal of four of their defibrillator leads after research revealed an increased risk of fractures which has resulted in unnecessary shocking of patients, premature battery depletion and in a few rare cases, death. This recall does not relate to any pacemaker models made by Medtronic.
An electrical "lead" is the wire that connects the heart to a defibrillator, a device used to shock faltering hearts back into normal rhythm. The company is urging all of the roughly 268,000 patients with the lead manufactured since 2004, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.
Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need. In most cases, the defibrillators can be reprogrammed without surgery to minimize the problem. Any defibrillator manufactured before 2004 does not contain the faulty Sprint Fidelis lead and users should continue use without worry.
Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. Those patients will require a delicate surgical procedure to replace the lead, experts said. Medtronic said it would stop selling the lead and recall all leads not yet implanted. To find out if a defibrillator is in question, lead numbers are listed on the implant cards below the actual device. The leads in question will start with one of these four numbers: 6930, 6931, 6948 and 6949 (actual lead number may be longer).
Replacing leads on a heart device like a defibrillator is considered to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly.
The Fidelis lead has been used with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have them. Patients who have recently had defibrillators replaced because their batteries were running down may not have the leads because doctors commonly attach replacement defibrillators to the existing leads when possible. Patients may have also had their defibrillator replaced with another manufacturer's defibrillator, so while the defibrillator in question isn't being used, the Fidelis leads may very well be.
The recall is the latest in a series of setbacks for Medtronic and its two main rivals in the $6 billion global defibrillator market, St. Jude Medical and Boston Scientific, which now owns Guidant. Sales have slumped in the United States in the last two years because of a string of safety recalls and concern among doctors that it is too difficult to identify which patients would benefit from the devices.
If you or someone you know has suffered injuries after having a Medtronic Defibrillator implanted, please contact us today.
Please contact us now (your privacy is assured). The secure form below only takes a couple of minutes to fill out, but if you are uncomfortable sending your information over the internet, please call our toll-free number at 800.921.1776 to speak to an attorney. The call is free, and there is no obligation. Act now, as delays can harm your case.
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