More Claims Filed over Medtronic Sprint Fidelis LeadsNov 5, 2009 | Parker Waichman LLP
Three more lawsuits have been filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations, reports the Madison Record. The three individuals, residents of Illinois, allege in their 60-count suit, that they suffer sudden shocks after being implanted with defective defibrillators made by the device maker, according to the Madison Record.
The complaints state that Lillian Tengstrand, Effie Thomas, and Marcus Williams received the implantable cardiac defibrillators (ICDs), which are surgically placed under the skin of the chest wall to decrease and increase heart rates, explained the Madison Record. Lead wires are placed into a major vein and attached to interior heart muscle. "Electrodes that sense the heart's rhythm are built into the lead wires and positioned in the heart, where they monitor the heartbeat and can transmit an electric shock to abort a dangerous 'overdrive pace,' a very rapid rhythm, or pace the heart at a normal rhythm if an irregularity is detected," the suit states, quoted the Madison Record.
If a lead breaks, the ICD can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart. The Sprint Fidelis lead was removed from the market in October 2007 following reports of five deaths due to lead fractures. Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.
Replacing a lead is dangerous and the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture. A choice with which many patients are uncomfortable. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.
"Any failure that compromises the ability of the lead to conduct electrical signals will result in a failure of the ICD to perform properly," the suit states. "Lead failures may include fractured wires, bending, insulation loss, loss of ability to capture changes in electrical characteristics in the ventricle chamber, abnormal lead impedance, sensing failure, and changes in tissue conductor interface," it added, quoted the Madison Record.
The plaintiffs were implanted with the Sprint Fidelis Lead Model Number 6949, allegedly defective due to “spot welding” to connect ICD cables to electrodes placed on the heart, say the three, reported the Madison Record. "The welding required to affix the Sprint Fidelis Lead cables can damage the fine, small wires in the cables," the complaint says. "The welding techniques used were inadequate and resulted in damage to the cables in many Sprint Fidelis Leads," reported the Madison Record, citing the complaint.
Although physicians did tell the device maker about the problems, Medtronic apparently disregarded the complaints and initiated a massive, $100 million ad campaign for its ICD products, said the plaintiffs. Medtronic claimed surgical technique, not faulty device leads, were to blame. Defective devices continued to be implanted until Medtronic finally issued a recall following what the plaintiffs described as ICDs failing at “an alarming rate” worldwide, according to the Madison Record.