Premature battery depletion with certain St — recall 55635

Reported risk: Health Canada is advising Canadians that some batteries in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D) manufactured by St. Jude Medical may deplete earlier than expected. Early battery depletion may occur suddenly, anywhere between hours and days, and without warning. According to the company, the chance of early battery depletion is small and appears to occur two to three years after implantation. Devices manufactured after May 23, 2015, are not affected by this issue. The following devices are affected: Fortify Assura DR Fortify Assura VR Fortify DR Fortify ST DR Fortify ST VR Fortify VR Quadra Assura Quadra Assura MP Unify Assura Unify Unify Quadra CRT-D Health Canada is urging patients with any of these devices to immediately contact the clinic responsible for their follow-up care for information and advice. Physicians can identify premature battery depletion through remote monitoring or in-person visits. St. Jude Medical has informed physicians and hospital administrators of this issue, including advising them not to use affected products in storage. The Canadian Heart Rhythm Society will also provide information to clinics, including a procedure for patient monitoring and follow-up. Incidents have been reported in Canada associated with early battery depletion. In most cases, battery depletion was discovered during routine follow-up medical visits without any reported symptoms. However, in two cases, patients reported symptoms such as loss of consciousness necessitating CPR, shortness of breath and fatigue. There are no known deaths related to this problem in Canada. Internationally, there have been two deaths and ten serious events (e.g., fainting, chest pain) possibly associated with this issue. An ICD is a microcomputer that is implanted under the skin of the upper chest area. It monitors heart rate and delivers therapy in the form of small electrical pulses. A CRT-D is a type of specialized ICD used to treat heart failure.