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On February 11, 2005, the leading maker of implantable cardioverter defibrillators (ICDs) and pacemakers, Medtronic Inc., issued a notification regarding certain implantable defibrillator models. The Medtronic warning 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.

Importance of Medtronic Warning

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.

Affects of Medtronic Warnings

Affected by the Medtronic warnings were 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.

Battery problems were first detected in 2003 when a battery malfunction in certain device models during internal quality testing occurred. After making modifications to the battery to correct it, the FDA approved the new battery redesign, but problems among patients began to crop up in the spring of 2004.

The Medtronic 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. According to Dr. Marshall Stanton, Medical Director of Medtronic’s Cardiac Rhythm Management division, this safety precaution may detect only about 10 percent of battery shorting cases because the battery may deplete too quickly for the tone to be produced.

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.

Contact our Medtronic lawyers for representation in your Medtronic defibrillator recall case.

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