Sprint Fidelis Defibrillator Attorneys
On October 15 th , 2007 Medtronic announced that it was voluntarily recalling their Sprint Fidelis Defibrillator Leads. Defibrillators are life saving products for patients with a heart rhythm abnormality. Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.
The Medtronic Sprint Fidelis Defibrillator Leads were found to be prone to fracture, which can cause the lead to send false signals, which will cause the defibrillator to deliver unnecessary shocks or not operate at all. Physicians were first notified in March about the leads fracturing, and there has been additional data accumulated since then. Some deaths and major complications have occurred after these leads have fractured.
The Sprint Fidelis Defibrillator was first introduced in 2004 and has been implanted in approximately 268,000 people. The FDA claims that the fracture has occurred in less than one percent of these patients thus far but they do not know if the rate of adverse events will increase over the life of the Sprint Fidelis Leads. Because there is not a test to predict which of the leads will eventually fracture, the FDA and Medtronic recommend that the defibrillators settings be adjusted in the patients next scheduled follow-up doctor visit.
The FDA also states that patients should recognize that a small amount of Sprint Fidelis leads have been used with defibrillators other than those manufactured by Medtronic. If you have any reason to believe they you have a Sprint Fidelis lead or you do not know the model of your lead, you should contact your health care professional.
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