Medtronic to report patient death to FDA: report

(Reuters) - Medtronic Inc (MDT.N) will report to the Food and Drug Administration (FDA) the death of a patient who underwent surgery with one of its products, the Wall Street Journal said, citing the Minneapolis-based company.

The company said for more than three months it did not know about the death of the patient, Shirley Nisbet, until last week when a lawsuit was filed by her family, the WSJ reported.

However, the hospital where Nisbet died did not report the death to Medtronic or the FDA because it did not consider the company's product to be the direct cause of death, the paper said, quoting the hospital's spokesman.

The newspaper said Medtronic had informed the FDA in August that Nisbet fell into a coma after a spinal-fusion surgery that used the company's implant for promoting bone growth.

U.S. regulators had previously warned that the company's bone-growth protein, InFuse was linked to life-threatening complications in spine repair surgeries for which it was not approved.

Medtronic could not be immediately reached for comment.

(Reporting by Eric Yep in Bangalore; Editing by Hans Peters)