TGA Warns of Problems with Boston Scientific Defibrillators

September 3, 2013 — The Australian Therapeutic Goods Administration (TGA) has issued a hazard alert to cardiologists and surgeons about the risk of battery depletion on some defibrillators manufactured by Boston Scientific.

This warning includes the Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).

Device and model numbers affected include:

• Cognis CRT-D: N106, N107, N118, N119, P106 and P107
• Teligen DR ICD: E110 and F110
• Teligen VR ICD: E102 and F102

Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that use small electrical currents to treat abnormal heart rhythms. They also coordinate heart beats in the left and right ventricles to improve the heart’s pumping ability. Only defibrillators manufactured before December 2009 are affected by the problem.

Some of the same models of have been linked to reports of malfunction, including at least one death. In April 2007, the U.S. Food and Drug Administration (FDA) issued a Boston Scientific Defibrillator Recall for approximately 73,000 ICDs and CRT-Ds due to the risk of battery depletion. In March 2010, the FDA warned that Boston Scientific had stopped shipment and started recalling all of their ICD and CRT-Ds that have not been implanted.