Be careful if your heart skips a beat. Guidant Corp., a company that develops therapies for cardiovascular and congenital heart disease, is recalling some of its pacemakers.
The recall comes after the Indianapolis-based company issued safety warnings on 11 models of its defibrillators last month, affecting more than 90,000 patients.
Guidant found the implantable defibrillators – devices that shock the heart back into a normal rhythm when they detect abnormal heartbeats – were malfunctioning. The malfunctions occurred when a magnetic switch inside the device got stuck and prevented the device from providing treatment.
In their final recall, Guidant identified 69 cases in which the pacemaker seal had failed in the device, allowing moisture to seep in. As a result, two of the patients affected suffered heart failure and one of them was hospitalized and died.
Pacemakers function like defibrillators to help the heart beat regularly and at an appropriate rate and generally have two parts – the generator and the leads. The generator is where the battery and the information to regulate the heartbeat are stored. The leads are wires that go from the generator through a large vein to the heart, where the wires are anchored. The leads send the electrical impulses to the heart to tell it to beat.
The Products: Nine models made from Nov. 25, 1997, to Oct. 26, 2000. Models are the Pulsar(R) Max, Pulsar, Discovery(R), Meridian(R), Pulsar Max II, Discovery II, Virtus Plus(R) II, Intelis II, Contak(R) TR.
Problem: Hermetic seal gradually degrades, allowing moisture to enter the pacemaker case. Problem typically occurs after product has been implanted four years.
Incidents: Company found 69 pacemakers with the seal malfunction and 20 cases of loss of pacing output because of the failure. Two patients suffered heart failure that may have been caused by the problem. One of those patients died.
Advice: If you have a Guidant defibrillator, you should check with your doctor to see if it has been recalled.
According to Guidant the pacemaker recall affects a total of 78,000 devices made from November 1997 to October 2000. None have been sold or implanted in the past four years and most of the 28,000 still in use are nearing the end of their warranty periods or are out of warranty.
Published: Aug 5, 2005