Medtronic
Medtronic is the world’s largest maker of devices that maintain a steady heartbeat. In February 2005, the company informed the FDA, doctors and patients that certain models (Micro, Insync, Maximo and Marquis) of its implantable defibrillator were prone to sudden failure due to defective batteries.
Device failure can result in a patient’s death—ranging from a matter of days to a few hours. The devices in question were put into service in 2001, 2002 and 2003.
The Medtronic voluntary recall, announced on February 11, 2005, affected about 87,000 people.
Three Medtronic recalls in 2005
The Medtronic voluntary recall, announced in February 2005, affected about 87,000 people. Less than two weeks later, Medtronic announced a recall of its Lifepak 500 automated external defibrillators.
These devices may fail to analyze a patient’s heart rhythm even when their electrodes are properly connected and the devices appear to be working correctly. The recall affects 1,924 Lifepak 500 devices, all of which were manufactured in 1997. The Lifepak 500 is used by first-responders such as firefighters and police officers who are first to arrive at the scene of a cardiac incident but lack significant medical training.
There have been more than 50 incidents with this group of defibrillators, including eight cases in which it may have prevented successful patient resuscitation.
Other Medtronic problems
In May 2005, a Medtronic recall of 13,000 defibrillators was announced, although nearly 2,000 of the potentially defective devices remain in use. But there were problems with other Medtronic products—such as its LifePak external defibrillators, some of which proved to have damaged cable connectors. So after it was cited by the FDA, another Medtronic recall was issued.
A Medtronic pacemaker recall was done in November 2005 for its Sigma Series. It had problems with the wiring that connects the pacemaker’s main circuitry to the device header. This defect can cause the device to fail, leaving patients at the mercy of their heart condition.
Serious risk for all patients
Approximately 40,000 Sigma Series pacemakers have been implanted worldwide; 19 of them have failed, hastening the Medtronic recall. Although the defective Medtronic pacemakers have not yet caused any deaths, they pose a serious risk for all patients using them.
Of the 40,000 Sigma Series devices implanted worldwide, about 28,000 remain in circulation (6,650 in the United States).
