Boston Scientific Corp.’s Cognis and Teligen defibrillators, used to shock a stopped heart back into a normal rhythm, may have a flaw that can cause the device to heat up and has been linked to one death, said Rick Wise, an analyst with Leerink Swann & Co.
An electrical transformer has shown a “pattern of malfunction,” Wise said in a note to clients, citing Boston Scientific’s Product Performance Report. The flaw has been detected in 26 of 233,000 units. One patient died.
The event rate is “extremely low,” he said, and shouldn’t affect the outlook of the Natick, Massachusetts-based company. Boston Scientific is rolling out a new generation of defibrillators that don’t include the transformer, Wise said. The devices haven’t been recalled and the company is providing doctors and patients with additional information, he said.
A panel of physicians and safety advocates regularly reviews the safety of Boston Scientific products, including the newly uncovered malfunction, Steve Campanini, a Boston Scientific spokesman, said in an e-mail. The company is committed to reporting quality issues to regulators and it stands behind the performance of the devices and safety systems, he said.
“While no medical therapy is perfect, the Cognis and Teligen family is performing within our reliability expectations,” he said.
Boston Scientific fell 1.1 percent to $5.88 at 2:17 p.m. New York time. The shares had risen 11 percent this year before Monday.
St. Jude’s Device
Defibrillator risks are getting more attention after St. Jude Medical Inc.’s Riata, which the company stopped selling in 2010, was linked to a rare malfunction caused when the wires used to connect the device to the heart broke free of the insulating cables.
A U.S. Food and Drug Administration advisory panel this week is reviewing the safety of Cameron Health Inc.’s defibrillator, which works without directly attaching the defibrillator wires to the heart. Boston Scientific agreed in March to purchase the closely held company for as much as $1.35 billion to get access to the device called the S-ICD System.
The defibrillator has been tied to inappropriate shocks and infections, the FDA said in a staff report that was released ahead of the April 26 meeting to review the device’s safety and effectiveness.
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