Heart disease is the leading cause of death in the United States. Heart disease encompasses a number of different diseases and conditions, including congenital heart disease, high blood pressure, high cholesterol, and arrhythmia. A specific problem that many people with heart conditions experience is an irregular heartbeat.
In a human heart, the natural pacemaker is called the sinoatrial node, or sinus node. The sinus node is a small mass of specialized cells that is located on top of right atrium of the heart; its function is to make electrical impulses that make the heart beat. Occasionally, people will experience a heartbeat that is too fast, too slow, or irregular (called heart arrhythmias). Arrhythmias are fairly common and often harmless. However, they may also be an indication of a serious problem, such as a defect in the body's natural pacemaker or a blockage of the heart's electrical pathways.
Artificial pacemakers are used to help the heart beat in a regular rhythm and replace a natural pacemaker or blocked pathway. They send electrical impulses to the heart to help it pump. Artificial pacemakers are small, battery-operated devices that may be permanently implanted or may be temporarily placed on the exterior of the body. When an artificial pacemaker is implanted in the body, an electrode is placed next to the wall of the heart that sends electric impulses through a wire to the heart. Pacemakers can help alleviate symptoms of arrhythmias, including fatigue and fainting, and help people to resume more normal, active lifestyles.
There are a number of companies that produce pacemakers. The Guidant Corporation is one company that manufactures pacemakers. Guidant pacemakers are products that have single or dual chambers, which are able to treat both sides or one side of the heart. It is created to provide a mild current of electricity to regulate the beating of the patient's heart.
In 2005 the Guidant Corporation issued a voluntary warning to doctors that many of its older pacemaker models may have had issues and unexpected behaviors that could have potential adverse affects. The U.S. Food and Drug Administration (FDA) issued the warning as a Class I recall, meaning that the product defect could lead to serious or life-threatening injuries.
The safety information issued by the Guidant Corporation noted that a seal in the pacemakers, used in 78,000 pacemakers manufactured between 1997 and 2000, could leak, which would allow moisture to affect the electronic circuits within the devices. This problem could cause pacemakers to fail or to cause a rapid heart rate. The problems could arise without warning and the defect in the pacemaker may not be immediately detected; this could result in fainting, unconsciousness, possible heart failure, or death. Because removal of a pacemaker can pose a risk to a patient, the manufacturer recommended speaking with a doctor about the most appropriate course of action regarding his or her pacemaker.
If you or a loved one experienced serious injury as the result of the defect in a Guidant pacemaker, or if the defect resulted in death, it is highly recommended that you speak with an attorney who specializes in medical device defects and laws surrounding them. The defect present in this pacemaker may have caused you or your family physical pain, as well as added unforeseen medical expenses.
A lawyer can guide you through the legal process, assess your medical records and history, and determine whether or not you can make a claim. Lawyers will be able to help you seek compensation and peace of mind.