Defibrillator Leads Made by Medtronic Recalled
The FDA Says Patients Who Have Them Should See Their Doctors, but the FDA is Not Recommending that They Be Surgically Removed
If the electronic wires fracture, that can cause defibrillators to deliver unnecessary shocks or stop working altogether, which can cause major complications or death.
The FDA, however, wants to assure the public that the likelihood of a fracture is very low. At this time, fractures have occurred in less than 1 percent of the approximately 268,000 leads that are currently implanted.
The FDA also wants to stress that even though it is characterizing this action as a "recall," the FDA does not mean to imply that devices that have already been implanted should be surgically removed. They say that the devices will continue to work properly in the "vast proportion" of patients.
Instead, what the FDA, along with the manufacturer, recommend is that the defibrillator settings be adjusted at patients' next follow-up visits with their doctors.
The FDA recommends that doctors weigh the risks and benefits of removal versus other options -- careful monitoring of patients, or capping the leads so they are no longer usable and implanting an additional device.
The FDA also said that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic, and that patients who have the Sprint Fidelis leads, or who don't know what kind of leads they have, should contact their doctors for more information.
The FDA also wants to assure the public that it is committed to ensuring that the risk to patients is minimized. It will continue to monitor the situation and take whatever other actions may be necessary.
Consumers who have questions can call the FDA at 888-INFO-FDA. Medtronic has also posted a letter for patients on its website, and the company has a number that patients can call for further information: 1 (800) 551-5544 x41835 (7 a.m. to 9 p.m. CST).
Sources
Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads, Food and Drug Administration Statement, October 15, 2007
Important Patient Information Sprint Fidelis® Lead Performance, Medtronic website, October 15, 2007
Published by May Monten
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