Boston Business Journal by Julie M. Donnelly, Reporter
Boston Scientific (NYSE: BSX) has disclosed that a rare malfunction in a part, used with two types of implantable cardiac defibrillators (ICDs), has caused one death.
The Natick, Mass.-based medical device company said that both ICD product lines, called Cognis and Teligen, are performing within reliability expectations, in an update to its quarterly product performance report.
“However, an electrical component referred to as a “transformer” has exhibited an identifiable pattern of malfunction that has occurred at a low rate (currently 26 out of 233,000, or 1 out of every 8,900 devices implanted),” the update stated.
The transformer is used in all implantable defibrillators to multiple the low voltage of the battery to the high voltage of a shock, and the company said the malfunctions occurred during a high voltage charging cycle. The malfunction caused “a sudden heating sensation to the implant site” in some cases, and one death, according to the company.
Boston Scientific is not planning to change the label on the device, is not recommending that physicians make and changes, and this is not a recall.
Implantable heart defibrillators have been under intense scrutiny lately, in light of other malfunctions, including with connecting wires, called leads, made by Boston Scientific competitor St. Jude Medical (NYSE: STJ).
Boston health care investment bank Leerink Swann analyst Rick Wise wrote in a research note that Boston Scientific is in the middle of transitioning to its next generation family of ICDs which do not use the transformer component in question.
“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 wrote.