On October 1, 2007, the United States Food and Drug Administration (FDA) sent a warning letter to Medtronic for omitting instructions, and in some cases providing misleading instructions, in an operating manual for one of its implantable medical devices.

Medtronic’s SATELLITE™ Spinal System is composed of spheres that are surgically implanted between a patient’s vertebrae to stabilize the spine.

The warning letter cited Medtronic’s violation of the Federal Food, Drug, and Cosmetic Act in its omission of a step for implantation of a bone graft and for providing faulty and confusing instructions for implantation “that could significantly affect its safety and effectiveness.”

Medtronic spokesman Bert Kelly said that the product has not officially launched and that only approximately 100 manuals were issued. Kelly added that Medtronic is working with the FDA to make sure the manual is compliant.

Click here to read the warning letter sent to Medtronic posted on the FDA website..

Sources: U.S. Food and Drug Administration, “Medtronic Warned Over Surgical Technique Manual, Press Release,” FDAnews Daily Device Bulletin, October 18, 2007; “FDA cites Medtronic for misleading spine surgeons,” Reuters, October 9, 2007.