Medtronic Sigma Pacemakers
Medtronic is a company that manufactures a variety of advanced technology medical devices and sells them to hospitals worldwide. In May 2009, Medtronic came out with a specific advisory, warning doctors and patients 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 premature depletion of the battery, no pacing output, rate response loss, total loss of function or unsteady telemetry (pacing and beats). 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). Medtronic also advises doctors whose patients have these devices implanted into them to continue with routine follow-up visits with each patient having the pacemaker. It was noted, though, that replacement of the device should be determined on a case-by-case basis, and only after thorough review and consultation with the patient. Patients are also recommended to immediately consult a doctor, should their symptoms return of their previous conditions, or if they feel lightheaded or lose consciousness.
A pacemaker refers to the pacing system that is used to correct certain heart ailments, such as bradycardia, or the slowing of the heart's rhythm. The system is comprised of three components: 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, because the loss of pacing output is generally not seen or felt immediately. Users of this particular series of pacemakers are even advised to consult their doctors on what needs to be done following the advisory.
If you suspect that the ailments you are feeling now are due to a defective Medtronic Sigma pacemaker, you should consult a lawyer now. 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, as 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.
