Boston Scientific warns physicians of a potential defect in its unique subcutaneous implantable cardioverter defibrillators.
Updated March 8, 2013, 2:30 p.m. with comments from Boston Scientific.
Boston Scientific (NYSE:BSX) recently issued a warning on its lead-free implantable defibrillators over concerns that a fuse malfunction could prevent the devices from delivering life-savings shocks, the company confirmed with MassDevice.com today.
The company has received reports of 4 instances in which a fuse inside the subcutaneous ICD was activated inappropriately, which could cause the devices to fail. No adverse events have yet been reported, according to Boston Scientific.
"The company is issuing a software update that takes less than a minute to complete using a programmer in the physician's office," Boston Scientific senior VP of global corporate communications Denise Kaigler told us today. "We recommend patients with recently implanted S-ICDs meet with their doctors for a follow-up visit to receive the software update."
Boston Scientific acquired the S-ICD technology last summer when it acquired Cameron Health in a deal worth $1.35 billion. The FDA approved the device in September 2012, and there are about 1,900 implanted in patients worldwide.
The device is the world's only commercially available lead-free implantable cardioverter defibrillator, delivering heart rate managing electrical shocks without needing wires threaded through blood vessels.
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