High lithium salt concentrations in the recalled pacemaker batteries can lead to a loss of life-saving heart rhythm support.
Federal health officials are warning that recently recalled Boston Scientific pacemaker devices may begin to malfunction as the battery nears the end of its life cycle, a defect that has been linked to two fatalities.
The U.S. Food and Drug Administration (FDA) issued a safety communication on December 16, warning that certain Boston Scientific Pacemakers may begin to malfunction and cause the devices to enter "Safety Mode," which severely limits its functionality and prevents the pacemaker from properly regulating the heart's rhythm and rate.
The manufacturer said the affected devices have a higher concentration of lithium salts in the battery cathode, which can lead to the Safety Mode issue. To date, two implant recipient deaths have been reported in connection with the Safety Mode problems
The affected Accolade devices are a set of pacemakers and cardiac resynchronization pacemakers. The devices are implanted into a patient's chest to treat abnormal heartbeat and to provide life-saving support in the event of severe heart failure.