BISMARCK, N.D. (AP) — A woman who says she's worried about problems with her implanted defibrillator is suing the maker of the device.
Winnifred Leverson, of Bismarck, N.D., is seeking class-action status in U.S. District Court in Bismarck against Fridley, Minn.-based Medtronic Inc. The suit was filed Monday.
The company pulled its Sprint Fidelis defibrillation wires off the market last month after identifying five patient deaths in which broken wires may have played a role. The wires, called leads, connect patients' hearts to a device that sends an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can leave the defibrillator unable to send a lifesaving shock, or prompt it to deliver painful unnecessary shocks.
Medtronic and Food and Drug Administration officials say the risk of breakage is low and fewer than 1 percent have failed.
The FDA advises patients not to have the wires surgically removed, a risky operation itself. Instead, doctors may monitor them carefully or consider capping the wire so it no longer works and implanting a different version, the FDA said.
Medtronic said about 235,000 people have the Sprint Fidelis lead wires.
Leverson would not comment on the lawsuit. Her attorney, Mike Miller, of Fargo, N.D., said Leverson's defibrillator lead is working and is not broken. He said she has not been unnecessarily ''zapped'' by it.
''She would like not to have a potentially defective lead in her,'' Miller said. ''Living with one of these defibrillators is a bit like living with a ticking time bomb in your chest.''
Miller said he also is representing 15 other North Dakota residents who have the implanted defibrillator leads.
The lawsuit alleges emotional distress and negligence, and it seeks restitution and medical monitoring.
Medtronic spokesman Rob Clark said the company did not have an immediate comment on the lawsuit. He said many similar lawsuits have been filed since the leads were taken off the market.
''We are aware of these types of suits and assertions being made,'' Clark said. ''These things will be litigated, and it will take some time.''