Medical device maker Medtronic, which is being sued by the family of a California woman who died after having neck surgery, is denying responsibility for her passing after going into respiratory arrest. 

Shirley Nisbet, of Vista, CA, according to a Wall Street Journal report, had Medtronic’s Infuse Bone Graft inserted in her neck in August, just weeks after the FDA reported the surgery could put a patient’s life at risk. 

The Fridley, MN-based company said, in a statement released Dec. 3, that its technical consultant denies recommending the off-label use of the Infuse Bone Graft. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  

“Medtronic does not promote off-label use of products, and physicians decide how medical products are ultimately used to the benefit of patients,” the company said.

The lawsuit was filed last week in federal court in Los Angeles by the family of Shirley Nisbet.