Medtronic Lawsuits News | Medtronics Recall Attorney Lawyer

Medtronic lawsuits continue to be filed on behalf of patients affected by the Sprint Fidelis Medtronics recall. Implantable Cardioverter-Defibrillators (ICDs) are implanted heart devices that shock dangerous abnormal heart rhythms back to a normal rhythm. The lead is a wire that connects the ICD to the heart. Medtronic, Inc., a Fortune 500 company based in Minnesota, manufactured Sprint Fidelis Leads, which are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart.

On October 15, 2007, Medtronic, Inc. announced that it was voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads after receiving reports of five (5) fatalities linked to lead fractures. This included four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. The Food and Drug Administration (FDA) considered this removal action to be a medical device recall. The recall pertains to the Sprint Fidelis lead only, not the implanted defibrillation or pacemaker device. These leads were recalled because of the potential for lead failure. These electronic wires are prone to fracture in a small number of patients. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.

Approximately 268,000 Fidelis leads have been implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States. At the time of the recall, Medtronic had confirmed 665 chronic fractures in returned leads and estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. As of March 13, 2009, the FDA’s MAUDE database, which contains reports of adverse events involving medical devices, had 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient’s death.

Unfortunately, there is no reliable way to test whether a lead may fracture. The FDA recommends that patients who have had the Sprint Fidelis lead implanted immediately contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Routine removal is not recommended by the FDA or Medtronic as the risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place.

However, there are two alternatives to removing the lead, neither of which is particularly comforting to a patient with the device. One is to continue using the lead while monitoring closely for signs of fracture. The other is to surgically add a replacement lead, which does not require removing the Sprint Fidelis lead but does require that it be capped or covered with a small plastic insulation.

We represent all Medtronics recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuits attorney will contact you to answer any of your questions.

We are continuing to fight for patients rights who have been affected by the Medtronic recall of Sprint Fidelis leads.