Pioneer Press, "FDA ups risk of Guidant defects"

          A potentially deadly short-circuiting problem with implantable defibrillators made by the former Guidant Corp. may be far more common than initially indicated, according to an analysis by federal regulators.
          Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit. A judge in a product-liability lawsuit involving Guidant's defibrillators recently unsealed the FDA document dated June 16, 2005.
          "This doesn't raise my concern level any higher than it already was -- which was pretty high," said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute.
In May 2005, Hauser and two Heart Institute colleagues went public after Guidant refused to warn other doctors about its defibrillator. Instead of delivering a sharp jolt to their 21-year-old Minnesota patient's heart, which had gone dangerously out of beat, the $30,000 device apparently short-circuited and the patient died.
          Since then, Guidant has been hit by a series of safety alerts, recalls, investigations and lawsuits. The company recalled 109,000 defibrillators because of a variety of problems last year.
          Guidant's heart devices are made in Arden Hills. Natick, Mass.-based Boston Scientific bought Guidant earlier this year.
          "My major concern is why the FDA didn't release this information at the time, a year ago," Hauser said.