Medical device safety in spotlight

-Kaiser Network

03/06/2008 - Doctors say that a massive product recall in October by Fridley-based Medtronic Inc. underscores the urgent need for legislation to protect recipients of medical devices by giving them and their physicians better information about emerging safety problems.

Dr. William Maisel, an expert on medical device safety at Boston's Beth Israel Deaconess Medical Center, writes in today's edition of the New England Journal of Medicine that the Medtronic recall is the latest example of how manufacturers and the U.S. Food and Drug Administration have failed to provide the public with timely, critical information about device malfunctions.

Implantable defibrillators are pager-size devices that generate electrical jolts that can shock failing hearts back into rhythm, and those devices are connected to the heart by lead wires. In October, Medtronic stopped selling a widely used lead wire called Sprint Fidelis after learning of a fracture risk that may have contributed to five patient deaths.

Rob Clark, a Medtronic spokesman, said Wednesday his company would welcome further discussion of patient protections, but argued that Maisel's editorial lacks specifics that might advance the debate. Clark also maintained Maisel's editorial omits key details in describing how the company handled the Sprint Fidelis matter.

"The narrative is incomplete and omits facts that are essential to any full accounting or analysis of the events and their ramifications," Clark said.

Maisel said

Advertisement that five months before Medtronic recalled the Sprint Fidelis lead wire, the company submitted an application to the FDA to change the product's design and manufacturing.

That request was not publicized to physicians or patients, Maisel wrote, even though doctors had received letters from Medtronic in February 2007 stating that there could be a problem with the lead. He noted that after FDA approved the design changes, old versions of the Sprint Fidelis lead remained on hospital shelves for use in patients.

"Often, a flawed product continues to be marketed while the manufacturer submits a revised marketing application to the FDA and awaits approval of the amended product design and manufacturing plan," Maisel wrote. "Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure."

But Clark said the Sprint Fidelis design change sought by the company in May had nothing to do with the problems that ultimately led to the recall. Manufacturers regularly make such design changes as they improve products, Clark said, and those changes don't indicate earlier versions are flawed.

He defended Medtronic's track record not only in the Sprint Fidelis recall but also an earlier recall of defibrillators that Maisel also highlighted in the editorial.

Dr. Robert Hauser of the Minneapolis Heart Institute, who last year helped bring the Sprint Fidelis problem to light, seconded Maisel's call for consumer protection legislation. Hauser published a medical journal article in July that suggested patients were being needlessly — and repeatedly — shocked by their Medtronic defibrillators because lead wires were fracturing at an unusually high rate.

The force of a defibrillator shock is similar to being kicked in the chest by a horse, Hauser said.

"When you stand back and look at this, what's so disturbing is that physicians started implanting this lead because it was FDA-approved — they thought, 'Well, it's a nice, small lead, and it's FDA-approved so it must be OK,' " said Hauser. "Just because a device is FDA-approved does not necessarily mean it is safe."

An FDA spokeswoman did not respond to questions.

In January, Hauser published a letter in a medical journal stating that Sprint Fidelis should have been fully evaluated in humans before it was market-released. But Clark said that a requirement for human tests of the sort that might have uncovered the Sprint Fidelis problem would bring product innovation to a halt.

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.