Medtronic sued over defibrillator in St. Clair County

Kelly Holleran Nov. 4, 2009, 7:11am

An Illinois woman says her recently deceased father died after a defective implantable defibrillator manufactured by Medtronic was inserted into his heart.

Delorean Coleman filed a lawsuit Oct. 14 in St. Clair County Circuit Court against Medtronic, Medtronic USA, Medtronic International Technology and Medtronic Puerto Rico Operations.

According to the complaint, Jason Coleman received an implantable cardiac defibrillator, which was used to correct his irregular heartbeat. The ICDs work after they are planted under the skin of the chest wall. From there, lead wires ejecting from the ICDs are inserted into a major vein and are attached directly to a muscle on the inside of the heart.

"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.

The lead wires are responsible for sensing how fast or slow the heart is beating, the complaint says.

"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."

Some of the Sprint Fidelis Lead Model Number 6949s, which was the type of ICD implanted into the Jason Coleman's body, were defective due to the spot welding that was used to attach the lead cables to electrodes placed on the heart to monitor its beating, the plaintiffs claim.

"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."

For example, the lead cables have been known to fracture near the site where they are welded to the electrodes, causing several patients to receive inappropriate shocks because of the broken wires, according to the complaint.

"Plaintiffs have suffered repeated shocks and fractures, after the enhanced monitoring system was in place, and the monitoring failed," the suit states. "Plaintiffs suffered these shocks and fractures without any alarm sounding from this purportedly 'enhanced' monitor."

Doctors advised Medtronic of the dangers of its ICDs, but Medtronic ignored their advice and instead launched a $100 million advertising campaign for its ICD products, the plaintiffs claim. The company blamed the doctors' findings on their implantation techniques and not on the device itself, according to the complaint.

Even after Dr. Robert G. Hauser of the Minneapolis Heart Institute insisted on presenting his findings on the allegedly defective ICDs to the Heart Rhythm Society, Medtronic hired numerous doctors to refute Hauser's report that was scheduled to be published in February 2007, the suit states.

According to Hauser's findings, about 1 to 2 percent of the Sprint Fidelis Model 6949 had failed, the complaint says.

Still, throughout 2007, Medtronic's Sprint Fidelis Model 6949s were being installed in people, even while Medtronic continued to receive worldwide reports that the devices were failing "at an alarming rate," the plaintiffs claim.

Finally, just after midnight on Oct. 15, 2007, Medtronic recalled the Sprint Fidelis Model 6949s. Although it did not offer to pay for monitoring costs, Medtronic did offer to reimburse patients with a new lead system if lead wires in the Sprint Fidelis Model 6949 were fractured, according to the complaint. In addition, the company offered to pay $800 toward unreimbursed medical expenses, the suit states.

Because he had the ICD implanted, Jason Coleman suffered injury, incurred medical costs, experienced disability, suffered a diminished capacity to enjoy life and suffered until his Aug. 12, 2008, death.

His wife and three surviving children lost his companionship, society and consortium because of his death, they claim.

In the suit, Delorean Coleman is alleging negligence through the wrongful death act, strict products liability, defective manufacturing, inadequate warning, negligent design, negligent manufacturing, negligent failure to warn, intentional infliction of emotional distress, negligent infliction of emotional distress, common law fraud, breach of implied warranty, breach of express warranty, negligent misrepresentation, loss of consortium and statutory consumer fraud.

She is seeking an unspecified judgment, plus costs and other relief the court deems just.

Seth Sharrock Webb of Brown and Crouppen in St. Louis will be representing her.

St. Clair County Circuit Court case number: 09-L-553.

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