Boston Scientific Says Some Implantable Defibrillators Are DefectiveJul 23, 2010 | Parker Waichman LLP
Boston Scientific is reporting problems with more of its implantable defibrillators. According to The Wall Street Journal, the company has advised physicians that three brands of the devices – Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs – may not work.
All of the affected Boston Scientific defibrillators were made in 2006 and 2007. They have been implanted in some 34,000 patients, the Journal said.
In an advisory for doctors, Boston Scientific said a magnetic switch on the implantable defibrillators can get stuck, stopping the devices from delivering an electric shock to the hearts of patients who need the therapy. The switch prevents the device from delivering shocks when doctors are performing an emergency procedure on a patient using a magnet that could trigger the defibrillator, the Journal said. Once the magnet is taken away, the switch should open and allow the device to resume normal functioning. According to the advisory, the switch would in rare instances stay shut.
The company maintains the risk of harm is remote, and it hasn’t received any reports of deaths or injuries. According to the Journal, some doctors have removed the defective devices from their patients, but Boston Scientific is recommending against this. The company says doctors can reprogram the defibrillators to correct the problem.
This is the third time in less than a year that Boston Scientific has had issues with some of its implantable defibrillators. As we reported previously, in March the company recalled seven brands of implantable defibrillators because it did not get approval from federal regulators for changes to its manufacturing processes. The brands impacted by that recall included: Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.
According to The Wall Street Journal, this past December, Boston Scientific warned that its Cognis and Teligen defibrillators had a design flaw that could result in the devices delivering unnecessary shocks to the small number of patients who had the defibrillators implanted under their chest muscles. The company later said it had fixed the problem.