Medtronics Lawsuits News | Recalled Sprint Fidelis Heart Leads Attorney Lawyer

The Medtronic recall deals with the Sprint Fidelis lead only and not the implanted heart device. The models that are affected by this recall are 6930, 6931, 6948 and 6949. To determine if your lead has been recalled, checked your patient ID card or wallet card. Under Model #, look for any of the following numbers: 6930, 6931, 6948 or 6949. Any of these numbers indicates you have a recalled lead. If you have one of the recalled leads, it is important you contact your doctor, especially if you have suffered multiple shocks, lightheadedness, fainting or palpitations.

According to Medtronic, since 2004 approximately 268,000 Medtronic Sprint Fidelis defibrillator leads have been implanted worldwide. Currently, according to the New York Times, it is estimated that around 150,000 U.S. patients are still implanted with a Sprint Fidelis Medtronic heart lead.

The FDA is not recommending routine removal of the device. If your lead is not fractured, then the FDA recommends that the defibrillator program settings be adjusted so that the device will provide early warning beeps when there is a change in the lead impedance. Replacing a lead poses such serious risk that the FDA and many physicians recommend continued use of the lead with careful monitoring of its performance.

If your Sprint Fidelis lead is fractured, then there are a couple of options your doctor will discuss with you. One option is surgical extraction of the fractured lead. However, surgical removal has serious risks and complications. At least four people have died during the extraction process. The risks related to surgical extraction include infection, puncturing or tearing of the heart, tissue, veins or vessels and potential damage to the heart valve. Many physicians prefer to implant a replacement lead model and cap off the old lead by covering the tip with a small plastic insulation so that the fractured lead is no longer operational.

Patients and doctors need to thoroughly weigh the risks and the benefits of any lead removal. Medtronic, in its March 2009 Physician Letter, explains that factors to consider when making the decision to extract and implant a new lead should include “patient life expectancy, age and co-morbidities, number of implanted leads and duration of implant, and patient preference.” The letter further states that “Medtronic’s Independent Physician Quality Panel recommends that if a lead requires removal, the procedure be performed by a physician with extensive lead extraction experience.”

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