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Medtronic sued over faulty defibrillators

2 recipients claim recalled device gave unnecessary shocks

MINNEAPOLIS - A man who claims he received 47 unneeded jolts from his implanted defibrillator is suing Medtronic over the broken wires the company is recalling.

Plaintiffs Leonard Stavish and Kelly Luisi seek class-action status in US District Court in Minneapolis as representatives of people they say were hurt.

The lawsuit's allegations include emotional distress and negligence, and it seeks restitution, disgorgement of profits, and punitive damages.

Medtronic Inc., maker of pacemakers and other heart devices, has acknowledged wires connecting its implantable defibrillators to patients' hearts break more often than it expected. It said five deaths may be linked to the broken wires. Medtronic said some 235,000 people have the Sprint Fidelis lead wires.

Medtronic spokesman Rob Clark said the company did not have any immediate comment on the lawsuit. He denied the lawsuit affected the timing of Medtronic's disclosure.

Attorneys for Stavish claim his defibrillator had to be removed because he got 47 unnecessary jolts. They said the device was replaced, and he got a new set of Sprint Fidelis wires.

The lawsuit also said Luisi went to the emergency room after experiencing "frightening episodes of unnecessary shocks." At the hospital, Luisi's defibrillator "began delivering unnecessary shocks over and over again," after someone from Medtronic used an instrument to check her device, according to the lawsuit. The wires were removed a month later.

Removing the wires can be dangerous because it may tear at scar tissue. The lawsuit said Luisi was forced to have her wires removed, "scarring her already fragile heart, and forcing her to undergo additional and unnecessary complicated surgery."

Hunter J. Shkolnik, an attorney for Stavish and Luisi, said they decided on Friday to file the lawsuit, and he said he has 25 more clients who will sue as their complaints are written up. He said he believes Medtronic disclosed the wire problems Sunday because it knew the lawsuits were on the way.

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