The May 5 subpoena from HHS "seeks information relating to the launch of the Cognis and Teligen line of devices in 2008, the performance of those devices from 2007 to 2009, and the operation of the Physician Guided Learning Program," Boston Scientific said in a regulatory filing yesterday.
In March 2009, the Natick, Mass.-based medical device company warned of a problem in some 8,000 of the Cognis and Teligen ICDs that was implicated in 15 cases of inappropriate shocks to patients. Another warning followed in December of that year over potential problems with the bond between the device’s header and case. Boston Scientific stopped making the Cognis and Teligen devices in December 2009.
In September 2013, Boston Scientific issued a new warning on the devices, advising physicians to watch out for premature battery depletion in older models.
Boston Scientific is not the only company in the cardiac rhythm management game to face scrutiny from federal officials. Earlier this week, St. Jude Medical (NYSE:STJ) revealed a U.S. Justice Dept. probe into allegations of illegal kickbacks to encourage physicians to its cardiac devices. In December 2013, Medtronic (NYSE:MDT) agreed to pay $23.5 million, but admitted no wrongdoing, to settle similar allegations by federal prosecutors.
And Boston Scientific itself agreed late last year to pay $30 million to settle a False Claims Act lawsuit filed over pacemakers made by its star-crossed Guidant subsidiary.