Boston Scientific Defibrillators’ Design Flaws

Boston Scientific’s Cognis and Teligen defibrillators have a design flaw that may cause the defibrillator to send unnecessary, powerful and painful electric shocks to the heart, according to researchers. The Wall St. Journal is reporting this morning that the defibrillator design defect may affect some 90,000 patients. According to the Journal, “Boston Scientific had warned in December that there was a problem with shocks with the defibrillators—the third of various types the company has disclosed with its Cognis and Teligen devices. But it said the problem was limited to the few patients who had the devices implanted deeper in their bodies, under their chest muscles.”
Reports of the defibrillator design defect was first noted in the journal HeartRhythm. Boston Scientific officials were quick to criticize the authors of the HeartRhythm article saying the article lacked a “detailed engineering analysis”. As if in response to the medical device company’s criticism of the authors the Journal points to their qualifications and their role in the medical device industry.
The HeartRhythm article was co-written by William Maisel, an authority on medical device safety and an assistant professor at Harvard Medical School. Another author, Joseph Germano at Winthrop University Hospital in Mineola, N.Y., said he has been paid to speak on behalf of leading medical device makers including Boston Scientific.
“Clearly their device had a problem, and their testing was not able to reproduce it,” said Dr. Maisel, who has advised the Food and Drug Administration about medical device quality.