Medtronic Inc., one of the world's leading makers of cardiovascular devices including pacemakers and Implantable Cardioverter Defibrillators (ICDs), has faced dozens of lawsuits related to battery depletion and the consequential malfunctioning of its defibrillators and pacemakers.

What are Defibrillators and Pacemakers?

Cardiac disease is one the biggest causes of death in the U.S., with close to 400,000 deaths every year. Implantable Cardioverter Defibrillators (ICDs) and pacemakers are devices used to stabilize the rhythm of the heart. A person suffering from bradycardia or slow heart rate may be implanted with a pacemaker or defibrillator. Pacemakers contain a battery responsible for the powering and proper functioning of the device.  These devices have made it possible for thousands of people to lead normal lives. Defibrillators and pacemakers are life saving devices, and any malfunctioning in any component of the device can cause potentially fatal consequences. 

In the case of Medtronic's pacemakers and defibrillators, a shorting defect in the battery was found to lead to a sudden and possibly rapid depletion of the battery.  This depletion could be slow and over the course of a few days or in just a few hours, causing the device to malfunction. In some cases, the battery depleted and the patient suffered a heart attack before they were aware of the problem. 

The company issued an advisory on February 11, 2005 warning that thousands of its Implantable Cardioverter Defibrillators (ICDs) and cardiac resynchronization therapy defibrillators were at risk for battery depletion, causing the device to fail. The advisory identified devices manufactured between April 2001 and December 2003 were prone to such shorting action. The devices identified to have shorting action were the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices.  Most of the defective defibrillators and pacemakers had already been implanted in American patients.  Since then, over 13,000 people have had their pacemakers and defibrillators surgically removed. 

In 2003 the design of the battery was changed to fix the problem, and a new battery design received FDA approval.  By 2004, however, it was clear that the problem still existed with the new design when the company received a battery removed from a patient after the device failed.

The surgery to replace the defective ICDs and pacemakers is one fraught with complications because of the risks associated with invasive surgery, like infections.  If you have been implanted with the Medtronic ICD or pacemaker, you should consider replacement under the advice and guidance of your cardiac surgeon.