Boston Scientific has disclosed that a rare malfunction in a part used with two types of implantable cardiac defibrillators (ICDs) has caused one death.
“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 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 said this is not a recall.
I always wonder how they determine whether or not a recall needs to be issued, i.e. how many deaths does it take?