Cardiac device specialist Guidant has been charged in the USA with concealing information on failures in three implantable defibrillator models that had caused at least seven deaths.
The US cardiac devices sector has since become quicker to warn regulators and the public of potential product defects.
Guidant is now part of Boston Scientific, which has agreed to pay $296 million on its behalf to settle the charges. The company is expected to enter a formal guilty plea in the coming weeks.
“We are pleased to resolve this matter,” said Boston Scientific spokesman Paul Donovan. “We continue to believe that Guidant and its employees acted in good faith and with the intention of complying with applicable laws and regulations.”
The faulty defibrillator models are the Ventak Prizm 2DR (model 1861) and the Contak Renewal (models H135 and H155). When Guidant recalled 109,000 of the devices in June 2005, seven deaths were linked to the failures.
In May 2005, a Minnesota patient using the Ventak Prizm 2DR died after his defibrillator failed. In November 2002, Guidant had changed the design of this device to correct a short-circuiting problem – but it had told the FDA that the changes did not affect the device’s safety.
In June 2004, a patient in Spain died after the failure of a Contak Renewal defibrillator. In March 2005, Guidant sent a product update to doctors that failed to note this death and other short-circuiting failures of the device. The notice to doctors was not reported to the FDA.
Boston Scientific bought Guidant in 2006. Annette Ruzicka, a Boston Scientific spokeswoman, said that the three defibrillator models have shown no problems since they were modified.
Cardiac device companies in the USA now include product performance reports on their websites to inform clinicians and patients.