May 26, 2005
Food and Drug Administration (FDA) officials have met with representatives of the Guidant Corporation to discuss a problem with the company's implantable heart defibrillator. The device has failed in at least 26 cases and is blamed for the death of a college student in March.
Guidant disclosed earlier this week that it knew about a design defect in the unit for three years but had not told doctors about the problem. The company said it changed the design in 2002 to remedy the problem. The company contends it has followed FDA guidelines in reporting problems to the agency.
The Ventak Prizm 2 Model 1861 is surgically implanted under the skin in a patient's chest. It is programmed to detect fibrillation -- a rapid and unsynchronized heart beat -- and to send out an electrical charge to restore proper heart rhythm.
Guidant notified doctors of the problem last Monday but did not recommend replacing devices already implanted in patients, saying the implant procedure posed risks. The New York Times said the company sent the advisory as the Times was preparing to publish an article about the problems with the device.
The devices in question were produced from 2000 until mid-2002. Defibrillators are normally replaced every five to six years becauase the batteries drain. Thus, most of the troubled units would soon be due for replacement anyway.
The 21-year-old student who died, Joshua Oukrop, had a hypertrophic cardiomyopathy, a relatively common genetic heart disease. Guidant has acknowledged that his device malfunctioned because of the design flaw.
Another defibrillator manufacturer, Medtronic, was quicker to address problems in one of its units. Medtronic said it has replaced 13,000 defibrillators since February, when it announced a battery-related problem. The company said it has spent $18 million so far on the replacement program. it is covering the full cost of the replacements.
Guidant is one of the largest makers of medical devices, with $3.8 billion in sales last year, almost half of that coming from implantable defibrillators.
