From the Wall Street Journal
Boston Scientific Corp. warned doctors of a rare defect that can cause implanted defibrillators to deliver improper shocks to the heart, adding to concern about the high-end medical devices.
The devices, implanted near the shoulder, deliver a jolt to restart stopped hearts and try to heal failing hearts. They cost about $30,000 apiece.
The affected models are among the first that Boston Scientific released under its own brand name after the company's $28 billion acquisition of defibrillator maker Guidant Corp. in 2006. Despite medical evidence that the defibrillators can extend the lives of people with heart failure, sales haven't recovered from a string of recalls since 2005 that hurt the devices' reputations.
In a letter earlier this week, Boston Scientific told cardiologists to turn off a sensor in the devices that records a patient's breathing rate. If left on, the breathing-rate sensor can cause extra shocks in rare circumstances, the company said. About 8,000 people, or 25% of all patients with the affected models, are using the breathing-rate sensor. Fifteen people have received improper shocks so far, and no deaths have resulted, the company said.
Implanted defibrillators consider a patient's heart rate, but not the breathing rate, when deciding whether to shock. Boston Scientific, which is based in Natick, Mass., didn't immediately explain why the breathing-rate sensor would lead to the improper shocks.
The Heart Rhythm Society, whose doctors implant defibrillators, said the problem was minor and correctable. Nonetheless, Christopher Warren, an analyst at Caris & Co., said it represents a "black eye" for Boston Scientific. "These products were supposed to correct years of engineering issues at Boston Scientific."
