Guidant Implantable Pacemakers
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 are be permanently implanted in 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, which is a maker of medical devices, including pacemakers, sent out a notice to doctors on September 22, 2005, on the reported two modes of failure of its Guidant implantable pacemakers models. These failure modes could lead to a number of things including the irregular or permanent loss of output in its pacing without displaying any kind of warning, the showing of a warning message for the reset of the device when it is asked to do a function, and the intermittent, or permanent failure of telemetry. One or more of these device malfunctions could occur because of the failure modes. The Food and Drug Administration (FDA) established this communication sent by Guidant to physicians as a recall action affecting two of its implantable pacemaker models.
The behaviors of the pacemakers, that were clinical in nature, linked to the failure modes could result in serious complications in the health of patients, who had pacemaker implants. The loss of the output for the pacing of the heart's rhythm was found to have caused syncope (or loss of consciousness) and presyncope (light-headed feelings), that led to the hospitalization of the patient. For the first mode of failure found, Guidant affirmed that there were 36 malfunctions among the 49,500 pacemakers implanted in patients, as of September 6, 2005. Seven of these defective medical devices displayed no output at all during implantation procedures. For the devices that were implanted with success, most of the malfunctions happened within seven months after it was implanted. Guidant received three reports of syncope and six reports of bradycardia, which is slower than normal heartbeat. In addition, there were a few cases in which there were telemetry failures.
Guidant predicted that an estimated seven to fifteen malfunctions could have potentially been added to the first 36 that were identified. These defective devices could be found among the population of the active pacemakers of 41,000, 24,000 of which were in the United States. Sixteen malfunctions were linked with the second mode of failure and these were confirmed among the 341,000 implantable pacemakers of the Insignia and Nexus models that have been distributed all over the world. The sixteen pacemakers showed no output when it underwent a pre-implant testing.
Guidant revealed that they had received a report of a patient, who is dependent on a pacemaker, losing consciousness and experiencing cardiac arrest. This report was linked to the pacing output loss during an elective procedure meant to replace a pulse generator. In June 2006, Guidant and the FDA also alerted patients and doctors about reports that there were five malfunctions of the implantable pacemakers that were caused by a defect on the low-voltage capacitor of the device. Intermittent or permanent loss of output and the premature depletion of the battery are among those that could be suffered by patients who have these defective devices.
If you suffered from complications or injury as the result of a problem with your Guidant implantable pacemaker, it is recommended that you speak with an attorney. A lawyer who is well-versed in laws surrounding defective medical devices, as well as personal injury cases, will be able to advise you of your next steps and guide you through the legal process.