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product_liability MedtronicIn October 2007, the number one maker of medical devices in the United States, Medtronic, voluntarily recalled its Sprint Fidelis defibrillation leads. The leads, which are electrical wires that send a shock to the heart during life-threatening arrhythmias, are prone to malfunction and can send unnecessary shocks or fail to deliver a lifesaving jolt when necessary. Malfunctioning leads have been reported in hundreds of patients, and deaths have been reported in five patients with the device.
If you or your loved one has suffered injury because of a malfunctioning defibrillator lead, you may be entitled to compensation. Contact us today to learn more.
Recalled Models
Four models were included in the Medtronic recall. They include Sprint Fidelis model numbers:
Patients who have been implanted with one of the recalled Medtronic models are urged to consult with their physician to determine whether or not the part needs to be replaced. Replacement surgery is dangerous, and most doctors will re-program the device rather than replace it. However, in cases where the device is not functioning properly, a patient may have no other option but replacement.
Device Defect Prompts Medtronic Recall
According to the Food and Drug Administration, the Medtronic recall was prompted by reports of lead fractures, a problem that could cause the lead to misread heart signals. Leads are medical devices that connect the heart to defibrillators, which are used to treat patients who have abnormal heart rhythms.
The Medtronic recall does not affect defibrillator devices themselves or pacemakers—only Sprint Fidelis electrical leads.
Patient Risk
Although Medtronic said the risk to patients is relatively small, thousands of patients may experience a lead malfunction. More than 230,000 patients have been implanted with a Sprint Fidelis lead, and the company said as many as 5,000 may suffer a lead fracture less than three years after the initial implantation.
Your Legal Rights
A malfunctioning lead can cause serious injury and even death. If you suffered a Medtronic lead malfunction, or your loved one died as a result of a faulty Medtronic heart device, it’s important to understand that you have legal rights. Contact one of our attorneys to today to arrange a free, no-obligation consultation. We’re happy to answer your questions and explain your legal options.
Medtronic, the world’s largest maker of implantable cardioverter defibrillators (ICDs), has agreed to settle 2,682 product liability lawsuits for $95.6 million.
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