Medtronic Pacemaker Information

Medtronic Inc., the largest maker of implantable cardioverter defibrillators (ICDs) and pacemakers, announced in February 2005 that certain implantable cardioverter defibrillator models and cardiac resynchronization therapy defibrillator models may have a potential battery shorting mechanism that could cause the devices to fail causing serious injuries or sudden death.

The Medtronic pacemakers affected by the safety warning included the Marquis VR/DR and Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D lines, with batteries manufactured between April 2001 and December 2003. The company began notifying physicians about the defective Medtronic Pacemaker on February 10, 2005, providing them with a list of potentially affected patients and recommending physicians speak with those patients about their options while closely monitoring them.

Medtronic defective defibrillators date back to 2003, when Medtronic first detected a battery malfunction in certain device models during internal quality testing. After identifying the electrical shorting mechanism, the company made modifications to the battery to correct it. Battery redesigns for Medtronic defective defibrillators were later FDA approved.

Problems among patients who had received devices containing the defective batteries were first reported in the spring of 2004, after a failed ICD that had been removed from a patient was returned to the company for analysis. Physicians discovered six of the nine reported failed batteries because of Medtronic defective defibrillators during patient visits.

At the end of February 2005, Medtronic also announced it was voluntarily recalling a limited number of Lifepak 500 automated external defibrillators because the device may continue to display a "connect electrodes" message, failing to analyze the patient's heart rhythm even when the electrodes are properly connected. Medtronic said it received 54 incident reports with the specific group of devices. The FDA classified the recall a Class I recall, meaning there was a situation in which reasonable probability that the use of or exposure to the product would cause serious adverse health consequences or death.