An executive with the device maker reveals that a subpoena was issued by the US Department of Justice concerning unapproved use of its Infuse Bone Graft product, Dow Jones reports. The disclosure comes on the same day Medtronic reported soft spinal-product sales in its recently concluded fiscal second quarter, due in part to flat Infuse sales.

The product is specifically approved for use in the lower back but has commonly been used in other areas. Sales in the recent quarter were hurt by a public-health notice warning against off-label use. Also, “related negative press coverage and payer pushback created some significant new hurdles,” Bill Hawkins, Medtronic’s chairman and chief executive, told analysts on a teleconference call today.

Last month, you may recall, two Senate committees wrote Medtronic seeking info about consulting contracts given doctors over its Infuse Bone Graft, which is approved for use in the lower spine, but has been linked to life-threatening complications. There are also questions about complications suffered by patients who underwent off-label procedures involving use in other parts of the spine (back story).

The move comes after news broke of a lawsuit brought by a former Medtronic lawyer, who alleged the device maker gave surgeons all sorts of interesting goodies to use its spinal implants, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in devising (back story). The relationships with docs generated another lawsuit brought by two other former Medtronic employees, who filed complaints against docs, specifically.

Hawkins added that Medtronic has recently received the Justice Department subpoena regarding off-label Infuse usage, and that Medtronic is complying with this request. “We take very seriously the whole notion of appropriate promotion for on-label use,” Hawkins maintained.