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Medtronic News

medtronic lead recall
Judge Dismisses Lawsuits in Medtronic Heart Device Case Minneapolis Star Tribune
January 6, 2009

Citing a recent U.S. Supreme Court decision, a federal judge in St. Paul on Monday dismissed dozens of lawsuits filed by patients who claimed they were injured by a heart device made by Medtronic Inc.

The patients were implanted with an electrical lead used in a defibrillator system known as Sprint Fidelis made by the Fridley-based medical technology company.

In October 2007, Medtronic's popular Sprint Fidelis lead was recalled by the Food and Drug Administration (FDA), because some had a tendency to fracture.

Suit Alleges that Medtronic Tried to Entice Doctors to Use its Devices Minneapolis Star TribuNe
December 11, 2008

Documents filed this week in a federal whistleblower lawsuit against some of the nation's top spine surgeons hint at a lucrative financial relationship between Medtronic Inc. and several doctors at Twin Cities Spine Center, a Minneapolis practice that is one of the largest of its kind in the country.

The whistleblower suit alleges that the Fridley-based medical technology company offered consulting and royalty agreements to induce doctors to use its innovative bone-graft product, Infuse, in ways not approved by the U.S. Food and Drug Administration (FDA).

Seven doctors at Twin Cities Spine are named in the suit, which was filed by two former Medtronic employees in U.S. District Court in Boston.

Patients Warned as Maker Halts Sale of Heart Implant Part The New York Times
October 15, 2007

The nation's largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths.

The faulty component is an electrical "lead," or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelsi, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.

medtronic sprint fidelis lead
Medtronic Suspends Sale of Heart Device MSNBC
October 15, 2007

Medtronic Inc. has suspended distribution of its Sprint Fidelis defibrillation leads after identifying five patient deaths in which a lead fracture may have been a contributing factor.

A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.

Medtronic Again Questioned Over Payments to Doctors, Is Subject of Senator's Inquiry The New York Times
September 27, 2007

An influential senator is raising new questions about payments made to spine surgeons by Medtronic, one of the nation's largest makers of medical devices.

Medtronic, which reached a $40 million settlement last year with the federal government over accusations that the company has paid illegal kickbacks to doctors for using its spinal devices, has continued to pay doctors millions of dollars in consulting fees, according to a lawyer representing a whistle-blower involved in the case.

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