At least three US government bodies have asked Medtronic to provide information on several separate issues, including the recent Sprint Fidelis defibrillator lead recall and possible violations of laws dealing with sales in other countries, the Wall Street Journal reports today.
The Senate Finance Committee, the newspaper suggests, wanted the Sprint Fidelis information as part of its investigation of the FDA’s oversight of medical devices. As recently reported by heartwire and around the world by the public media, the company recalled the leads, one of its more successful products, because of evidence that they might be prone to fracture. At least five patients had died possibly as a result of Sprint Fidelis failures.
Medtronic, the WSJ continues, has also disclosed that the Securities and Exchange Commission (SEC) had asked for information about possibly illegal “payments made to foreign doctors” as part of an informal probe of the company. The Department of Justice asked the company for whatever materials it sends the SEC.
A entry in a WSJ blog elaborated on that issue a little, noting that the “foreign doctors” were in, at least, Greece, Poland, and Germany. “Other device makers have disclosed receiving similar letters, according to Medtronic,” the entry notes.
And, finally, “the US attorney’s office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician’s groups related to the purchase of the company’s cardiac stents and cardiac-therapy devices,” according to the news story, which further notes that a particular unnamed “customer” had been singled out for investigation.