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Medtronic Recall Overview
On October 15, 2007, Medtronic, a world leader in medical technology, voluntarily recalled their Sprint Fidelis Defibrillation Leads (model numbers 6930, 6931, 6948 and 6949). The Sprint leads are designed to protect individuals who have potentially life-threatening heart rhythm irregularities. However, due to a malfunction in the technology, these leads may now cause injuries instead of preventing them. It is possible that the defective leads have already lead to five deaths and several injuries. Medtronic is asking medical professionals to return unused leads and they are sending letters to patients directing them to contact their doctors for guidance on the issue.
What is the Malfunction?
The Sprint Fidelis Defibrillator leads are surgically implanted into a patient’s shoulder and contain one or more leads that connect to the patient’s heart. Medtronic announced, in its recall letter, “There is a small chance of fractures in particular locations on the Sprint Fidelis leads.” The defibrillator is designed to monitor the patient’s heart rhythms and deliver an electric shock or rapid pacing to return the heart rhythm to normal when an irregularity is detected. The fractures may cause excessive shocking or no response at all to irregular heart rhythms.
Patient’s Options
As of October 4, 2007 approximately 172,000 patients in the United States had Sprint leads implanted to control irregular heart rhythms. The Medtronic recall letter directed those patients to contact their physicians for additional information about the potential effects of a defective lead. According to the Food and Drug Association, there is no specific test that can determine whether or not previously implanted leads are defective. The recall letter recommends that patients who have the recalled Sprint Leads already implanted consult with their physicians to determine if it is better to remove the leads or to cap them, both of which require surgery. Experts are warning that surgery to have leads replaced can be very risky. Another option available to patients is to talk to their physicians about having their defibrillator settings adjusted to increase the chance that a faulty lead will be detected before it causes harm.
Medtronic’s Actions
Medtronic has stated that they will replace the defective Sprint leads with an older version of the device called the Sprint Quattro and they will pay up to $800 in medical expenses not covered by insurance. However, Medtronic has also stated that they will not pay to have non-defective leads replaced because a patient has simply lost faith in the product.
What Now?
Thousands of cardiac patients are now finding themselves in a state of elevated emotional distress, not knowing if their life-saving device will actually save their lives if necessary. Critical decisions are necessary to determine what course of action each patient should take to ensure their safety. Cardiac patients affected by this defect have already started filing lawsuits against Medtronic alleging that product liability statutes have been violated and that Medtronic misrepresented their product when they knew it could be defective. Medtronic and the FDA are investigating to determine if there was negligence in this matter, and if so, to what extent. If recipients of the Medtronic Sprint Fidelis leads feel that they are entitled to compensation from Medtronic, they should seek the advice of an experienced product liability and personal injury lawyer.
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