Medtronic Inc., the second-largest medical device maker, will report to Food and Drug Administration (FDA) the death of a patient who underwent surgery with one of its products and has been sued by shareholders over claims of misleading investors about one of its devises.

Shirley Nisbet, the patient in question fell into a coma after a spinal infusion surgery which used the company's Infuse implant devise to promote bone growth.

The hospital where Nisbet died did not report the death to either Medtronic or the FDA as it did not consider the company's product to have directly caused the patient's death said a hospital spokesman. Medtronic came to know about Nisbet's death last week when her family filed a lawsuit.

The company was sued by the shareholders who owned Medtronic shares for a one-year period starting in November 2007, in federal court in St. Paul over claims that it misled investors about the profitability of its bone growth devise called Infuse a surgically implanted protein. The lawsuit claims that the sales were more dependent on applications not approved by the U. S. Food and Drug Administration than Medtronic had disclosed and that the omissions inflated the company's stock price.

According to the suit Medtronic "did not disclose that the extensive off-label usage of the Infuse was the result of an unlawful campaign by defendants to market and encourage off-label use of the product." The "false and misleading statements concerning Infuse artificially inflated the price of the company's publicly traded securities."

The Minneapolis-based company said this month it has been subpoenaed by U. S. regulators in a probe of possible kickback payments. Previously U. S. regulators had warned that the company's bone-growth protein, Infuse was not approved and was linked to life-threatening complications in spine repair surgeries.