Medtronic Sigma Pacemakers
Medtronic came out with an advisory recently that warned doctors and patients alike about their Sigma series of pacemakers. The subset of these Medtronic Sigma pacemakers, according to its manufacturer, has the tendency to fail because of the detachment of its interconnecting wires from its hybrid circuit. This defect may be clinically presented as a depletion of the battery before its time, no pacing output, rate response loss, or total loss or unsteady telemetry.According to Medtronic, there were no reported injuries or deaths among patients implanted with Sigma pacemakers due to the noted defect.
Nineteen devices were found to have this defect, which shows an incidence rate of an estimated 0.05 percent among the affected Sigma pacemakers subset. There are an estimated 28,000 of these Sigma pacemakers worldwide that are affected with this defect advisory. The United States has some 6,650 of these pacemakers.
Because of the low probability of the pacemaker's defect, Medtronic is not recommending the replacement of these pacemakers among patients before the normal elective replacement (ERI). The manufacturer of these potentially defective Sigma pacemakers also advises doctors whose patients have these devices implanted into them to just continue follow-ups as was practiced per patient. It was noted, though, that replacement of the device should be determined on a case-by-case basis and after thorough review and consultation with the patient. Patients are also recommended to immediately consult a doctor, should their symptoms return or they experience lightheadedness or loss of consciousness.
A pacemaker refers to the pacing system that is used among persons to correct certain heart ailments, such as bradycardia, or the slowing of the heart's rhythm. The system is comprised of three components, which are the pacemaker, the pacing lead, and the programmer. The pacemaker and the pacing lead are implanted within the chest of the patient, while the programmer is stored in the clinic or hospital for the doctors or nurses to keep track of a patient's progress. The pacing system corrects the heart's rhythm defects. It is not meant as a cure for any heart disease, though, or as a preventive measure for a heart attack.
Although there are no reported injuries or deaths due to the defect found in the Medtronic Sigma pacemakers, it is possible that any pacemaker malfunction might pose a health risk on the user. This is because the loss of pacing output is generally not seen immediately. Users of this particular series of pacemakers are even advised to consult their doctors on what needs to be done after the advisory was sent out. If you are among those who suspects that the ailments you are feeling now are due to a defective Medtronic Sigma pacemaker, you should consult a lawyer now. Your lawyer is experienced and knowledgeable when it comes to Medtronic products, so he will know which way to go in proceeding with your case. In getting a lawyer to help you with a Medtronic case, you should be aware that as of March 2006, there were an estimated 2,000 lawsuits pending against Medtronic. Because of this, you have to seek the assistance of a lawyer who is willing to stick it out with you until the end. The best lawyer for you will also be able to answer your questions regarding the Medtronic Sigma pacemaker that could have caused your ailment. He should also be persistent and dedicated in establishing that it was really your Medtronic Sigma pacemaker that caused your injuries. You are entitled to receive financial compensation for the suffering and anguish that you went through because of the injuries that you incurred as a result of your defective heart device.
You have to be sure to contact a lawyer as soon as you suspect injuries caused by your pacemaker, because there are statutes of limitation that restrict you from filing a case after a given period of time. Most of the states in the US generally adopt the statute of limitations that allows a victim to file a personal injury claim within two years of an injury.
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