Boston Sci heart device malfunction led to patient death

Problems with defibrillators have been in the news a lot lately. Reports have particularly zeroed in on the controversy over St. Jude Medical's ($STJ) recalled Riata defibrillator leads. But now, rival Boston Scientific ($BSX) is experiencing its own problems after the revelation of a flaw in its Cognis and Teligen defibrillators. The flaw could cause the defibrillator to heat up and seems to have already caused a patient's death. 

Boston Sci has tried to minimize fears, as the flaw appeared in just 26 of 233,000 units. "There are no additional clinical recommendations beyond current standard of patient care and current device labeling," the company says in its product performance report.

The problem appears to be with the transformer, and the malfunction has led to "sudden heating sensation at the implant site, likely due to rapid battery depletion," the company says. Unfortunately, one patient death has been linked to the malfunction and a panel of experts that reviews Boston Sci products discovered the new problem.

Leerink Swann's Rick Wise doesn't seem to think it will cause many problems for the company, given the low incidence rate and lack of recall, according to Bloomberg. Furthermore, the company is moving toward a next-gen family of ICDs that won't use the transformer.

"We think that this issue will not affect the company's outlook and continue to recommend BSX shares in the belief that the company as a whole now is steadily moving in a positive direction toward ever-increasing financial strength, a return to sales growth, and steadily expanding profitability," Wise writes, as quoted by Mass High Tech.

Even though the problem doesn't appear to be widespread, it does come right after the brouhaha surrounding St. Jude's Riata. That controversy could have an impact on St. Jude's bottom line, if doctor reactions have been any indication. Many of the doctors who are looking twice at St. Jude's heart rhythm devices may turn to competing products.

- get the Bloomberg story
- read the MHT report
- check out the product performance report

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