Back in March, Medtronic sent letters to doctors warning them about the risk of fractures in leads and reminding doctors of the proper way to use the leads. By this point, some doctors had already realized that the Sprint Fidelis leads were prone to fracture. However, patients were not made aware of the problem until March, when Medtronic recalled the leads. Many patients are now concerned that they have defective leads that may fracture, causing them to experience serious, unnecessary shocks or causing their defibrillator to not administer a necessary shock.

Meanwhile, a shareholder who alleges that the company concealed information about defective lead wires has also filed a lawsuit. The suit seeks unspecified damages from Medtronic and claims that Medtronic’s actions constitute securities fraud.

According to the lawsuit, since October 15, the day that sales of Sprint Fidelis leads were suspended, shares in Medtronic have dropped from $56.33 to $45.99. At the time, Medtronic reported that at least five confirmed deaths have been linked to defective lead wires. The lawsuit seeks class action status on behalf of those who bought Medtronic stock between June 25, 2007 and October 15, 2007, the period during which Medtronic allegedly made false and misleading statements. Among the statements was a claim in a securities filing that the Sprint Fidelis leads had a “strong market acceptance,” and a claim that there was increasing clinical data to support the use of Sprint Fidelis leads.

However, by January 2007, Medtronic allegedly already had 679 reports of injuries caused by defective leads. According to the lawsuit that number grew to 795 by April 30, 2007 and then jumped to 1,053 injuries reported two months later. Furthermore, Medtronic learned in February 2007 that the Minneapolis Heart Institute would stop using Spring Fidelis leads in its surgeries and replace them with the Sprint Quattro leads.

Medtronic has estimated that the failure rate for its leads is around 2.3 percent. That is just over two times the failure rate of the company’s other leads. However, the risk of serious complications associated with replacing the leads can be as high as seven percent. Replacing the Sprint Fidelis leads can cause damage to the veins that the leads run through.

Patients who have recalled Sprint Fidelis leads implanted are understandably concerned that their leads could fracture and fail at any time, putting their lives at risk. Those who have already had their leads fail report that the unnecessary shocks are incredibly painful.

November 15th, 2007

SOURCE: Sprint Fidelis Lead Recall › Medtronic Sprint Fidelis leads facing more lawsuits

The lawsuits were filed against Minnesota-based Medtronic by Kenneth Carlile of Kansas City and Phillip S. Brown, a Johnson County resident.

The complainants contend that Medtronic was negligent in its design of electronic wires – known as SprintFidelis leads – that connect the defibrillators to patients’ hearts.

Medtronic in October voluntarily recalled the Sprint Fidelis wires because they can fracture, which causes them to give unnecessary shocks or not function at all. Medtronic said it had identified five patient deaths “in which a Sprint Fidelis lead may have been a possible or likely contributing factor.”

The Carlile lawsuit was filed in federal court in Kansas City and the Brown lawsuit was filed in federal court in Kansas City, Kan. Carlile received his implantation at the University of Kansas Hospital in November 2004, and Brown received his implantation at Menorah Medical Center in Overland Park in August. The hospitals are not defendants in the lawsuits.

Each lawsuit contains six counts, including allegations of negligence and failure to warn patients of problems with the Sprint Fidelis wires earlier.

Medtronic spokesman Rob Clark said the company did not comment on the specifics of litigation filed against it, adding that lawsuits could be expected when the company recalled products.

November 12th, 2007

SOURCE: Sprint Fidelis Lead Recall › Two men sue company over design of defibrillator