Guidant Revises Safety Recommendations For Some Defibrillator ModelsJul 22, 2005 | AP
Guidant Corp. issued an urgent warning to doctors today saying a recommendation it issued just last month to fix a problem in three of its implantable defibrillators may actually make matters worse.
The company said a programming change it suggested to physicians in June may "significantly increase" the risk that a magnetic switch in the Ventak Prizm, Vitality and Contak Renewal devices would become stuck and prevent them from providing treatment.
Defibrillators are pacermaker-like devices that shock a heart back into normal rhythm when a rapid, irregular beat is detected.
The company said Friday it found that a malfunction had occurred in one of the devices after it was reprogrammed. In that instance, the patient was not injured, but had to have the device replaced. Guidant said it is now investigating other instances of malfunction, including a possible injury.
Guidant last month issued safety warnings on 11 models of its surgically implanted defibrillators, affecting about 88,000 of the devices, after two malfunctions. The company on Monday issued warnings on nine of its implantable pacemaker models.
The earlier defibrillator malfunctions resulted in two patient deaths, and the U.S. Food and Drug Administration classified Guidant's safety warnings about the devices as recalls. The agency also plans to assign its highest priority recall to some number of the pacemakers, FDA spokeswoman Julie Zawisza said Friday.
The FDA continues to work with Guidant to address the programming problems with its defibrillators, she said.
"We are working with the firm to better understand the nature of the software problems so that they may be fixed as soon as possible," Zawisza said.
The Indianapolis-based company said it notified physicians Friday that its programming recommendations heightened the risk of malfunctions in the three models, but did not elaborate on what alternative recommendations it may have made.
Messages left Friday seeking comment from Guidant officials were not returned.
Guidant's most recent announcement came a day after it reported its second-quarter profit dropped 15 percent, led by the costs of recalling and replacing its implanted defibrillators. Guidant has offered to pay for replacing or reprogramming the faulty devices and has anticipated taking a $113 million charge associated with the actions.
John Putnam, a senior vice president and analyst with Stanford Group Co., said the programming problem was "unfortunate" but not entirely surprising considering the complexity of the cassette tape-sized defibrillators.
"When you think about a defibrillator, they're really computers, 24-7. They're pretty sophisticated and it's not surprising, I guess, that they had an additional problem," Putnam said.
Shares in Guidant, which has agreed to be acquired by New Brunswick, N.J.-based Johnson & Johnson for $25.4 billion, fell 35 cents to close at $69.28 in trading on the New York Stock Exchange.