Researchers Say Boston Scientific Defibrillators Pose DangersFeb 11, 2010 | Parker Waichman LLP
Boston Scientific Corp.’s Cognis and Teligen brand defibrillators have a design flaw that can cause them to deliver unneeded, painful, and life-threatening shocks, according to an article in the journal HeartRhythm. The Wall Street Journal is reporting that the article’s authors say the Cognis and Teligen defibrillator defect could affect any of the more than 90,000 devices implanted in patients right now.
In December, Boston Scientific reported that the part connecting the defibrillator’s case to the leads to the heart had come loose on defibrillators implanted under the chest muscles of two patients. However, the company said in January that the problem had been fixed on defibrillators in production. Boston Scientific also said the problem was limited only to those patients who had a Cognis or Teligen defibrillator implanted under their chest muscles, rather than those who had it under the skin. About 5 percent of patients receiving the devices have had them implanted under chest muscles.
According to the HeartRhythm article, the design defect recently caused a Cognis defibrillator to deliver an unnecessary shock to the heart of an 84-year-old man who had the device implanted just under his skin. The authors said Boston Scientific has received two other reports of problems in patients who got the defibrillators implanted above their chest muscles, The Wall Street Journal said.
William Maisel, an authority on medical device safety and an assistant professor at Harvard Medical School, and Joseph Germano at Winthrop University Hospital in Mineola, N.Y. authored the article. According to The Wall Street Journal, Germano has been paid to speak on behalf of Boston Scientific and other device makers.
Boston Scientific did confirm those reports in a statement it issued Wednesday. However, according to The Wall Street Journal, the company said its own testing showed the problem didn’t cause the defibrillator to deliver inappropriate shocks. Boston Scientific also criticized HeartRhythm for publishing the article without a “detailed engineering analysis.”