A medical device manufacturer owned by Boston Scientific was charged Thursday with failing to report safety problems with some of its implantable defibrillators, lifesaving devices used to detect and treat heart rhythm abnormalities.
The Justice Department filed criminal charges following a four-year inquiry into the subsidiary Guidant that alleges the company knew about problems with some of the devices as early as 2002 but did not issue a public warning until 2005.
Boston Scientific released a written statement saying it was pleased to settle the matter, Dow Jones Newswire reported.
Boston Scientific is expected to enter a formal guilty plea in federal court. In November, the company announced it would pay $296 million in agreement with the Justice Department to resolve the charges.
From the Department of Justice press release:
According to the information filed today in federal district court in St. Paul, Minn., Guidant concealed information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant’s handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005.
ICDs are lifesaving devices used to detect and treat abnormal heart rhythms that can result in sudden cardiac death, one of the leading causes of mortality in the United States. The devices, once surgically implanted, constantly monitor the electrical activity in a patient’s heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.


