What is the fracture rate for patients with the recalled Medtronic heart lead?
In 2007, the FDA stated, “Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don’t know if this rate of adverse events will remain constant or increase over the life of these leads.” The number of injury reports filed with the FDA for the Sprint Fidelis lead, however, have increased with time, suggesting the fracture rate is also increasing. Clinical studies have found a much greater failure rate than reported by the FDA. In a 2006 study of patients at Cornell University Medical Center, 17% of patients experienced abnormal right ventricular sensing, requiring early revision (change out) in 4% of patients. Likewise, a study published in 2004 found the Sprint Fidelis lead functioning in only 88% of patients studied three years after being implanted. Also relevant is that the recalled Medtronic heart leads, because of their smaller diameter than competing products, were often u
