Heart “leads” are thin insulated wires connected to a defibrillator that carry electric impulses to the heart. These heart leads are designed to save lives when extremely abnormal and dangerous heart rhythms occur. Specifically, the device delivers an electrical shock that keeps the heart from beating excessively fast for persons who are at risk of sudden cardiac arrest.
In late 2007, the Medtronic Corporation issued a recall of its Sprint Fidelis heart lead. The recalled device, unfortunately, was already implanted in well over 200,000 patients. Medtronic has attempted to downplay the seriousness and magnitude of the failure rate. Not to mention, the manufacturer has refused to disclose the reason(s) causing the product’s failure. An independent study released in early 2009 concluded that the heart lead’s failure rate has been considerably higher than what the manufacturer proposed. The malfunctions of the heart leads have caused the product to fracture while inside the patient, resulting in serious injuries and even death. These fractures cause the innocent patients to suffer continuous and debilitating electrical shocks. Also, the fractured leads can puncture the heart itself or fail to protect the heart in times of need. Such malfunctions often have fatal consequences for the patient. Of course, surgery is required to remove the fractured, defective leads. This form of surgery is extremely risky and quite complicated.
While Medtronic’s Sprint Fidelis heart leads have been taken off the market, it has been reported that the company knew of the failure rates at least a year prior to issuing the product recall. Patients who have had the Spring Fidelis heart lead implanted should contact their physician or surgeon, even if they have not experienced any abnormalities. Symptoms of a defective heart lead include multiple shocks, faintness, dizziness, and heart palpitations. However, it is critical that all heart lead patients know that the risks of removal are high; therefore, it is not wise to pursue this option unless and until such action is medically advised. Sprint Fidelis patients have the option of electing to have their current lead capped with plastic insulation and have a replacement lead added.
Pursuing and achieving an award for a product liability claim is a difficult job. This task is further complicated when the allegedly defective product is medical in nature. Fortunately, the attorneys at Florida Defective Medical Device Attorneys Rue & Ziffra can weave through the intricacies of your product liability claim and see to it that you begin your journey to recovery. Contact the Rue & Ziffra law offices at 1-888-246-8613 or visit our website at Florida Defective Medical Device Lawyers www.RueZiffra.com to find out more about the many ways in which we can help you and your family.
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