Medtronic Pacemaker Recall

On February 11, 2005, Medtronic Inc. issued a notification regarding certain implantable defibrillator models. The Medtronic recall was in response to reports that nine batteries experienced rapid battery depletion due to a shorting mechanism.

Implantable cardioverter defibrillators are devices designed for patients with certain forms of heart disease or defects that have put them at a recurring risk of cardiac arrest. Once the device is implanted, the defibrillator delivers electronic pulses or shocks if sensing a cardiac rhythm is out of sync.

Because implantable defibrillators are used in patients who have shown recurring risk of cardiac arrest or attack due to fibrillation, the Medtronic warning was extremely significant considering the device's important role in preventing sudden deaths. The company began notifying physicians about the Medtronic warning on February 10, 2005, providing them with a list of potentially affected patients. Physicians were advised to communicate the Medtronic warning to these patients and to monitor them closely.

The Medtronic recall included the Marquis VR/DR and Maximo VR/DR ICDs and the InSync I/II/III Protect cardiac resynchronization therapy defibrillator devices (CRT-Ds) with batteries manufactured between April 2001 and December 2003. About 75 percent of the devices potentially affected by the Medtronic warning were implanted in the United States.

The Medtronic recall warning reported that nine batteries experienced rapid battery depletion, and physicians discovered six of the cases during patient visits. The Medtronic warning also recommended physicians turn on the patient alert system in the devices, which is part of the original design and produces an audible tone when the battery is low.

There have been 13,000 people worldwide who have had the devices surgically removed. Replacing the devices comes with risks such as infection. Some patients have accused Medtronic of implementing changes to correct the battery problem back in 2003 while continuing to market and sell existing inventory of ICDs and CRT-Ds affected by the Medtronic warning.

If you or a loved one have suffered injuries or have legal concerns related to these products, please immediately contact our service. In a Medtronic Pacemaker Recall case, you could recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. We can out you in touch with professional attorneys who are experienced with Medtronic Pacemaker litigation.