Boston Scientific has just issued a warning in relation to two of its implantable defibrillators, bringing the company under fire for the second time this year. The defibrillators at issue, Cognis and Telogen, are associated with 26 confirmed reports of malfunctions, and the warning comes after one of these incidents resulted in a patient’s death.
The defibrillators, which are devices implanted that deliver a therapeutic dose of electrical energy to the heart in individuals effected by life-threatening cardiac arrhythmias, ventricular fibrillation, and pulseless ventricular tachycardia, each contain a transformer which is at the heart of the malfunction. A transformer’s defibrillator is supposed to turn low voltage doses of electrical shock into high voltage ones so that the heart can properly be shocked back into its regular rhythm. The malfunction has occurred due to rapid battery depletion and a loss of programming that results in a sudden heating sensation in the implant site.
This news comes during what was already a rough patch for Boston Scientific, which earlier this year paid a record criminal penalty of almost $300 million after ti was discovered that they withheld information about certain safety deficiencies in two of its products- the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Each of these products also had short circuiting issues which were originally discovered in 2002 and 2004 respectively, although no safety warnings were issued until 2005.