The Wall Street Journal

June 2, 2005 Thursday


LENGTH: 820 words

HEADLINE: Guidant Sold Heart Device After Discovering Flaw

BYLINE: By Thomas M. Burton and Anna Wilde Mathews


Guidant Corp. continued to sell a heart defibrillator -- and allowed it to be surgically implanted in patients -- even after discovering a rare malfunction in 2002 that caused some of the devices to fail to operate.

The Indianapolis company earlier said it became aware of the problem in 2002 and made a manufacturing change but didn't say what happened with the original devices. People familiar with the matter now say the company continued to sell the original device, and allowed it to go into patients, knowing that two devices had malfunctioned.

People familiar with the events said Guidant concluded in 2002, and still maintains, that the malfunction, in which the device short-circuited and failed to administer electrical therapy to patients, was so rare that it didn't warrant a recall of the product. They didn't specify the number of devices installed in patients after the malfunction was found, but Guidant has estimated that a total of about 24,000 are still implanted in patients' chests.

Guidant is in talks with the Food and Drug Administration about the defect in the Ventak Prizm 2 Model 1861 defibrillator, and the company had no public statement yesterday on the talks. Guidant sent out a notice last week that there have been 26 cases of malfunction out of 37,000 devices made. One of these cases involved the death of a 21-year-old college student from Grand Rapids, Minn., Joshua Oukrup.

The people familiar with the events didn't immediately know whether the young man's defibrillator was one of those that were sold, and surgically implanted, after the defect was discovered. Calls to the Oukrup home and to one of his doctors in Minneapolis, Robert G. Hauser of Abbott Northwestern Hospital, weren't returned.

Doctors and patients were generally unaware of any problem until last week, when the company sent out its notice, though it had notified federal regulators, beginning in 2002, whenever it knew of a malfunction.

A malfunction in an electrical heart defibrillator, even if rare, can be extremely serious. That is because the underlying medical condition is so serious. Defibrillators are designed to dispatch a jolt of electricity to patients whose hearts have begun quivering so rapidly that they are unable to pump blood. The electricity is designed to restart a normal heart rhythm, and has saved many patients' lives. When the device doesn't work, the abnormal rhythm generally will result in death within minutes.

Guidant's notification to doctors last week about the short-circuiting problem came after physicians presented information about the Oukrop case at a heart-rhythm society medical meeting. The company said last week that it concluded in 2002 not to send out a recommendation to remove the product, in large part because of the risk of infection or other operative risk from installing a new device.

Moreover, the company said in its May 23 notice that, even though it notified the FDA about the early short-circuiting in 2002 and about the manufacturing change, it believed that even the new, remedied version of the defibrillator didn't have a statistically better profile than the earlier version. Dr. Joseph M. Smith, the company's chief medical officer, said in an interview last week that this was because the short-circuiting problem was so rare in the first place.

An FDA statement yesterday said, "No clinical events have been reported in units with the modified design." The agency said it met with Guidant and that the company "told us that they had submitted 26 adverse event reports to us. We are checking our database to confirm receipt of these reports. We also have requested additional information from the firm about the scope of the problem and their analysis of the failure mode. We are now in the process of reviewing information from our meeting with Guidant to determine whether further regulatory action may be warranted."

Medtronic Inc. of Minneapolis, a crosstown competitor of Guidant's St. Paul, Minn., defibrillator business, also found a manufacturing flaw in one of its Marquis defibrillators. This defect, the company found, could mean that the battery would become depleted too quickly in as many as 1.5% of the 87,000 devices made.

Medtronic sent out a notification to doctors about the defect in February and has received a huge response from doctors. In the U.S., 11,000 of the machines have been surgically removed and replaced with a different device, and 2,000 more such removals have taken place overseas.

A Medtronic spokeswoman, Valerie Lind, said, "As soon as we decide to communicate with physicians, we do it quickly. Sales representatives begin talking with doctors within the first day or two." She said that the "vast majority" of devices do get pulled off hospital inventory shelves immediately, but that it's possible that a small number could get implanted in the first day after a recall.

PUBLISHER: Dow Jones & Company, Inc.