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Sprint Fidelis® Implantable Cardiac Lead DeviceOn October 15th, 2007, the world’s leading maker of implantable heart devices, Medtronic, issued a voluntary recall of its Sprint Fidelis® defibrillation leads because of the potential for lead fractures, reports of at least 5 patient deaths and other serious, life-threatening complications. In a statement to the FDA, Medtronic reported These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured. The Sprint Fidelis® lead has been implanted in approximately 268,000 people worldwide. The Sprint Fidelis® lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude. The U.S. Food & Drug Administration (FDA) is recommending that patients who have had the Sprint Fidelis® lead implanted should contact their physician immediately, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Medtronic Sprint Fidelis® Recall ListThe following model numbers of the Sprint Fidelis® family of defibrillator leads have been recalled:
The Sprint Fidelis® lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude. Signs of Lead Fracture / BreakageIn the circumstance where a lead malfunctions, breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered. What are Cardiac Leads A Lead is part of an implantable heart defibrillation system that has three main parts: the defibrillator, leads, and a programmer. Two parts of this system are placed inside the body. The defibrillator is a small metal case that contains electronics and a battery. It is similar to a pacemaker in that it is designed to correct arrhythmias. But while a pacemaker increases a slow heart rate, a defibrillator detects and corrects fast and slow heart rates. The leads are specialized, thin, insulated wires that connect implantable cardiac defibrillators and resynchronization devices to the heart. Leads sense the heart's rhythm and deliver therapy to the heart (as directed by the defibrillator). The third part, the programmer, is kept in a hospital or clinic. A doctor or nurse uses this specialized computer to monitor and change the instructions of the implanted defibrillator. If any part of the system fails to function as indicated, a patient is at great risk for serious injury. We have been contacted by individuals whose leads have failed prematurely leading to replacement. We have also seen a recent rise in reports to the FDA of similar failures. If you or a loved one have a Sprint Fidelis® cardiac lead, you may be entited to compensation. CALL US NOW for a free consultation. CALL TOLL
FREE: 1-888-393-2029 |
HOT TOPICS YAMAHA RHINO ROLLOVERS(Serious injuries & death) Postarthroscopic Glenohumeral Chondrolysis (Pain Pump)KIDNEY FAILURE (FDA ALERT FOR TRASYLOL) Medtronic Sprint Fidelis® Heart Defibrillator Leads Voluntary Recall
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