Painful shocks linked to device

-Courier Press

03/28/2008 - The defibrillator wire implanted in Belinda Jean Klein's chest was supposed to detect and correct arrhythmias in her heart. But in a federal lawsuit, the Evansville woman claims the device delivered painful shocks that led to her hospitalization instead.

In the products liability lawsuit filed in U.S. Southern District Court this week, Klein claims manufacturer Medtronic Inc. was aware of problems in patients who had the Medtronic Sprint Fidelis defibrillator lead wire, model number 6949, implanted but did not remove the wire from the market until October.

The device was implanted in Klein's chest Feb. 7, 2005. It was designed to detect heart arrhythmias and correct them by delivering a shock to the heart, her attorney said. The defibrillator in her chest was connected to her heart by a wire that is placed in the vein and attached to the heart muscle. Information about the heart's rhythm is then transmitted through the wire to the defibrillator.

But on March 28, 2006, Klein suffered "inappropriate shocks, severe pain and hospitalization," the complaint states.

The complaint alleges that beginning in 2006, Medtronic officials "had knowledge and information" that the lead wires were fracturing and failing to work as necessary, "causing harmful shocks and in some cases, failure of the defibrillator to work at all, leading to untimely deaths."

But Klein's attorney said she was unaware other patients were having problems with the wires until October, when the company removed the wires from the market.

Rob Clark, spokesman for Medtronic, said 268,000 such wires have been implanted in patients around the world, but the problems have been reported only in about 2.3 percent of those patients.

"Multiple data sources were telling us that about 97.7 percent were free from fracture, and that the fracture rate was about 2.3 percent," he said.

Clark said he could not comment on Klein's case specifically, but he defended his company's reaction to the reported problems.

Clark said Medtronic first warned clients in March 2007 of possible problems with the wire. From there, the company conducted studies to assess whether there was a problem and what might be causing it.

"When we had information warranting removal from market, we did," Clark said. "We feel we took the appropriate actions and communication along the way."

Company officials voluntarily removed the wires from all markets in October 2007 because of the increased risk of fracture in the lead wires.

Despite Clark's insistence his company acted appropriately, Klein alleges in her complaint that Medtronic officials "concealed or downplayed" the known risks with the lead wires in an effort to continue marketing and selling the devices worldwide.

Evansville attorney William Woods is representing Klein. He said her lawsuit soon will be transferred to join others proceeding in multidistrict litigation in Minneapolis, Minn., where Medtronic is based.

Woods said although the wires are no longer on the market, there are still thousands of people implanted with them.

"The problem is that to replace these wires, it's a danger to remove it," he said.

"The skin and tissue grows around it, so the people that don't have a defect or the symptoms are faced with deciding, 'Do I replace this and go through the procedure and potential for problems, or leave it and wonder?'"

Clark said researchers identified two potential design issues that could cause the fractures.

"Design changes have been made, and we'll continue to work on those and are seeking approval from the FDA," he said.

When the wires were removed from the market in October, Clark said physicians were provided with an array of patient management recommendations, which also were posted on Medtronic's Web site.

Ennis & Ennis, P.A. is representing individuals that have been harmed by defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation.