Medtronic To Report Death Of InFuse User To FDA

Law360, New York (December 12, 2008, 12:00 AM EST) -- Medtronic Inc. is expected to report to the U.S. Food and Drug Administration the death of a woman who underwent a surgery that used the medical company's InFuse spinal graft product, which has been linked to life-threatening complications in dozens of patients.

The company contends that it did not know about the death of Shirley Nisbet for more than three months after its report to the FDA that she had fallen into a coma in late August until Nisbet's family filed a wrongful death suit against...
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