The plaintiff in the most recent lawsuit filed, a resident of North Carolina, had surgery in January 2006 to implant a cardiac pacemaker/defibrillator (ICD) that included Sprint Fidelis leads. According to the lawsuit, the leads in the device failed and the patient required a second surgery to replace the leads. As a result of the defective leads, the plaintiff allegedly suffered physical injury, emotional distress and economic loss.
Medtronic already faces a class action lawsuit filed in Minnesota that alleges the company was negligent and misrepresented and concealed possible defects of the Sprint Fidelis leads. They also allege that Medtronic sold the lead wires despite knowing that they had a greater risk of serious injury than other defibrillator wires. Plaintiffs in the class action seek relief for breach of implied and express warranty, negligence, intentional and negligent infliction of emotional distress, unjust enrichment and medical monitoring.
Many patients have already suffered serious injury as a result of defective Sprint Fidelis leads. They note that the unnecessary shocks they receive cause a great deal of pain and not knowing when those shocks will be administered causes anxiety. Patients note that the shocks can happen at any time and without any warning. This can be especially dangerous if a patient is driving or involved in another activity when the shocks are administered. Furthermore, defective leads can cause the defibrillator to not administer a shock when it is necessary.
Sprint Fidelis lead wires attach the Medtronic implantable defibrillator to the patient's heart and administer shocks when necessary to regulate and correct the patient's irregular heart rate. Sales of the leads were suspended on October 15, 2007 after five confirmed fatalities were linked to fractured Sprint Fidelis leads.
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So far, the FDA has received at least 1,600 reports of injury or malfunction because of defective Sprint Fidelis Leads. That number is virtually guaranteed to increase because most patients will not have lead their wires replaced if they have not malfunctioned and the lead wires generally malfunction up to 30 months after implantation.
Medtronic already faces lawsuits over its 2005 recall of some of its defibrillators. More lawsuits will likely be filed regarding Sprint Fidelis Leads as more of the leads malfunction and patients experience the painful side effects.