Boston Scientific Safety Alert on Older ICD Models

Disclosures

July 23, 2010

July 23, 2010 (Natick, Massachusetts) A number of Boston Scientific implantable cardioverter defibrillators (ICDs) manufactured between January 2006 and November 2007 could have problems with a magnetic switch, meaning they might not deliver shocks when necessary, the company told the Reuters news agency yesterday [1].

Confirming a report issued Wednesday, Boston Scientific chief executive Ray Elliot said the devices--the Contak Renewal 3 and 4 and the Vitality HE ICDs--are not sold anymore and are not in hospital inventories, although 38 000 are implanted in patients worldwide. But the company says the possibility of patient harm is less than one in a million devices, and no deaths or injuries have yet been reported because of this problem. It does not recommend that the faulty ICDs be replaced; rather, it says doctors should continue routine follow-up. The device will emit an audible beeping tone if a problem occurs and in that case, the patient should go to the emergency department, it advises.

Dr Laurence Epstein (Brigham and Women's Hospital, Boston, MA) agrees. He told Reuters that he believes the risk of having a problem related to this issue is smaller than the risk of surgery to replace the ICD. "This is one of those cases where [the company] is reporting it because of the need to be transparent, but the chances of anything happening is so small that, as a physician, I'm not going to do anything about it," he said. "I don't want people to panic. There's no ticking time bomb."

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