Medtronic Lead Recall Overview - By: Steve294 Fields294,

Medtronic Sprint Fidelis Recall
Sprint Fidelis is a product of Medtronic Inc., which is one of the world’s largest medical technology companies based in Minneapolis. Sprint Fidelis leads are cardiac electrodes that connect cardiac devices such as cardioverter-defibrillator or cardiac resynchronization therapy defibrillator to the heart. These electrodes play a very important role in maintaining regular heart rhythm in patients with heart problems. These electrodes are meant to give an electrical shock to bring the heart rhythm to normal whenever fatal heartbeat rhythms are detected. Patients who face the risk of cardiac arrest are fitted with these defibrillators through a surgery.
Medtronic recalled this product in October 2007. The recalled models include Sprint Fidelis – 6930, 6931, 6948 and 6949. It is a voluntary suspension by Medtronic after they found out that the leads had fractures which can lead to malfunctioning of the equipment. They may cause shocks that are not appropriate or they may stop functioning. As a result Medtronic not only recalled their product but also advised physicians to stop implanting their product any further and all the unused leads had to be returned to the company to ensure that there are no further implantations.
This news has made many people who had undergone heart surgery to panic as they were not sure whether they also have a Sprint Fidelis lead implanted in them. Patients are advised to contact their physicians to get further guidance. The normal course of action has been that they are advised not to remove the existing lead as the risk factors are higher than retaining a lead with fractures. Alternatively, a replacement lead can be placed without removing the existing lead. However, the tip of the existing lead has to be capped with a plastic insulation. Prior to any form of treatment the patients have to be reviewed for symptoms such as multiple shocks, fainting, light headedness, or palpitations. If such symptoms are to be evident then they have to take alternative course of action as per the guidance of their cardiologists.
There are allegations that the fracture in Sprint Fidelis may have caused few reported cases of death. Some serious injuries to the heart have also been reported where the diagnosis indicate fracture in Sprint Fidelis as a possible cause. It has been estimated that almost 268,000 leads have been implanted worldwide as of October 2007 and out of that almost 172,000 leads have been implanted in the United States.
Medtronic, though it has voluntarily withdrawn the product, it has lost its credibility in the medical circles. As one of the leading medical technology companies, it had many other types of medical equipment. People have started doubting all the other products from Medtronic. It is the responsibility of the physician to keep the patient informed about the products that they will be using during a medical procedure so that the patient can decide to choose a different product with the guidance of the physician. Medical recalls always raise moral questions on the issue of negligence by the medical companies that do not put their products to complete test before releasing the product. Those who have been affected have to be duly compensated.

Steve Fields is author of this article on Sprint Fidelis Recall. Find more information about Sprint Fidelis Recall here.

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