Two defibrillator brands made by Boston Scientific Corp. have a design flaw that can result in the devices delivering potentially life-threatening shocks to the hearts of patients, authors of a medical journal article say.
The defect can cause the Cognis and Teligen brand defibrillators to deliver the shocks when they aren’t needed in the many patients who get the devices implanted just under the skin, according to an article in the journal HeartRhythm. The potential malfunction, while appearing to be extremely rare, could in theory affect any of the more than 90,000 devices implanted, said the authors. They advised physicians to look for the problem should the devices malfunction.
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.
Defibrillator malfunctions are rare, affecting about 1% or 2% of the devices, according to studies. But even rare events have become more important as use of the devices has expanded to the prevention of heart problems. Guidant Corp., now owned by Boston Scientific, in 2005 recalled faulty defibrillators. Medtronic Inc. in 2007 suspended sales of the wire that connected a patient’s heart to the device.
As recently as last month, the company said the issue was limited to the 5% of the 98,000 Cognis and Teligen patients with defibrillators implanted under their chest muscles, rather than the remaining patients who have the devices implanted above the muscles but under the skin.
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