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On October 15, 2007, Medtronic issued a recall of its Sprint Fidelis defibrillator leads due to reports of at least five patient deaths associated with the product. On the same day of the recall, patients filed a series of personal injury and class action lawsuits against Medtronic.

Medtronic actually refuses to call its actions a recall.  Instead, Medtronic announced it was issuing a "voluntary market suspension" of distribution of its Sprint Fidelis defibrillation leads.  Medtronic has stated that "fractures in the Sprint Fidelis leads may lead to audible alerts, inappropriate shocks and the loss of output."

The Sprint Fidelis lead has been implanted in approximately 268,000 people worldwide since 2004, with roughly 235,000 patients still relying on these implanted leads. Even if you do not have a Medtronic brand defibrillator, you may still be affected by the recall, because Sprint Fidelis leads were also used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude.

Defibrillator leads are thin insulated wires that connect the heart to a defibrillator and carry electric impulses to the heart in patients with a heart rhythm abnormality.  Leads monitor the heart’s rhythm and also carry a shock to the heart if the heart falls out of rhythm. When one of the leads malfunctions, breaks, or "fractures," the lead may send false signals that cause inappropriate or unnecessary defibrillator shocks, or the defibrillator may not operate at all and shocks may not be delivered.

The leads are difficult to extract, because in most cases the leads are threaded into the blood vessels.  Tissue forms around the leads, which makes them difficult, if not impossible in many cases, to take out if there is a recall.    

The FDA has stated that fractures have occurred in less than 1 percent of the defibrillator leads implanted worldwide. The number of injury reports filed with the FDA for the Sprint Fidelis lead, however, has increased over time, and this suggests that the fracture rate is also increasing.  Clinical studies have found a much greater failure rate than the FDA reported.  In a 2006 study of patients at Cornell University Medical Center, 4% of patients required early revision (changing out) of their defibrillator leads.
 
Medtronic heart leads, because of their smaller diameter than competing products, were often used in young adults and pediatric heart patients.  Medical researches have reported a higher fracture rate with this population.  It is believed the leads come under greater stress in more-active people, including kids, teenagers and younger adults.  While the smaller lead may be easier for doctors to thread, the problem with the Medtronic lead is that it has a tendency, most likely because the leads are smaller than the technology can support, to crack, thereby distorting the signals being sent to and from the defibrillator. 

In addition to at least 5 patient deaths caused by the fractured leads, over 1,600 injury reports due to Medtronic defibrillator leads have been filed over the past two years, and more than 750 of these reports listed the patient as having received "inappropriate shocks."  Many patients with fractured defibrillator leads have experienced terrifying and devastating episodes of repeated electrical shocks due to a fractured lead.  In some cases, the lead did not operate properly when the patient experienced abnormal heart rhythms, and the patient has died.

If you or a loved one has been injured by the Medtronic Sprint Fidelis lead, contact us immediately. You may be entitled to compensation. Call the Law offices of Carabin and Shaw, P.C. for a free consultation at 1-800-862-1260.