Medtronic CD Horizon: Caveat Emptor

Memphis, TNCaveat Emptor or "Let the buyer beware" usually refers to the sale of real property after the date of closing. But the doctrine can also apply to Medtronic CD Horizon , an innovative lumbar fusion which was approved by the FDA only based on risk analyses by Medtronic, which allegedly claimed the device was "substantially equivalent" to instruments the FDA had already approved. In other words, it did not require pre-market approval application. That doesn't bode well with patients who may be facing another back surgery to have the defective device removed.

Medtronic doesn't have a great track record. In 2007 the company recalled its Sprint Fidelis leads after acknowledging five defective device-caused deaths and has since admitted to 13 fatalities (Medtronic first reported adverse events caused by its defective device in 2004 and by the end of 2005, FDA had received 30 complaints). Not reassuring statistics for those who have Medtronic CD Horizon implants.

Susan claims she can't even have another surgery. "The device cables are not stable," she says. "I keep it turned off now because it didn't work properly and was very painful and nobody will take the darn thing out! I can't even have an MRI because the cables go up to my cervical spine."

Anne says she was implanted with the Medtronic CD Horizon but during surgery it broke. "A Medtronic representative was present during the operation but apparently lost the remaining portion of the [broken] device," she says in a complaint. "The FDA says no report on this mishap was filed. A sharp blade-like disk remains lodged next to my spine, preventing any MRI type tests and creating a host of other risks, continued back and limb pain and loss of feeling and mobility, severe depression and inability to work."

Medtronic recalled all lots of its CD Horizon Agile Dynamic Stabilization Device in December 2007. In a Dear Doctor letter, Medtronic wrote that "devices can fail if not used in appropriate applications. Greater risk is associated with the degree of instability, whether it is pre-existing or created at the time of surgery…breakages may result from traumatic events such as a fall, or in extreme scenarios which include, but are not limited to improper screw placement and rod tightening technique."

Is Medtronic blaming doctors for a broken cable? Could a patient cause a broken cable? In a roundabout way, this letter sounds like Medtronic is saying both to doctor and patient, "Buyer Beware".