Cognis and Teligen Defibrillators May Have Deadly Defect

According to a recent article in the journal HeartRhythm, Boston Scientific Corp’s Cognis and Teligen brand defibrillators have a dangerous design flaw. Defibrillators are portable electronic devices that automatically diagnose possibly life-threatening irregular heart rhythms in a patient, and help the heart re-establish effective rhythm with the application of electrical therapy.  The defect in the Cognis and Teligen defibrillators by Boston Scientific may cause the devices to deliver unnecessary and life-threatening shocks to patients, and may affect the 90,000 patients who have the devices.

In December 2009, Boston Scientific reported the cases of two patients where the defibrillator that connects the device to the heart became loose. In January 2010, Boston Scientific stated the problem was fixed, and that the defect was limited to patients with defibrillators implanted under their chest muscles. However, HeartRhythm reported that Boston Scientific received at least three reports of problems from the defect in patients who had the device implanted above their chest muscles.