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Medtronic Implantable Cardioverter-Defibrillator (ICD) and

Cardiac Resynchronization Therapy Defibrillato(CRT-D) Defibrillators

Medtronic, Inc., (NYSE: MDT), a manufacturer of implantable heart devices, issued a recall of several of its implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. These devices are generally implanted in patients who are at risk for life-threatening heart rhythm problems or advanced heart failure. Patients typically suffer from symptoms that include fatigue, shortness of breath and difficulty performing daily activities.

An ICD is a medical device that is implanted into a patient’s chest for the purposes of monitoring and attempting to correct abnormal heart rhythms, or arrhythmias. ICDs correct arrhythmias by generating low-intensity electrical pulses that regulate the heart beat, allowing the heart to beat normally. This regulation occurs to keep the heart beating at regular intervals when the heart is otherwise beating abnormally fast or slow. Similarly, a CRT device works by coordinating the beating of the right and left ventricles. If the ventricles are not in rhythm, the blood is pumped by the heart in an inefficient manner and an inadequate amount of blood reaches all the parts of the body. When the CRT is working properly, blood is effectively pumped. 

The Medtronic voluntary recall, announced on February 11, 2005, impacts as estimated 87,000 people. As part of the recall, Medtronic advised physicians that a potential battery shorting problem may occur, causing rapid battery depletion. As a precursor to the recall, Medtronic notified patients and their physicians about the problems with these medical devices. 

In the notification letter, Medtronic reported instances of its ICD and CRT-D batteries experiencing rapid battery depletion, warning that electrical shorts could cause this battery depletion within a few hours or over the course of several days. The result of this depletion is a complete loss of effective device function. Loss of function would result in loss of heart beat regulation and either irregular beats or inefficient pumping of blood to the body. 

According to Medtronic, the devices with these malfunctioning batteries were produced between April 2001 and December 2003. The recall impacts the following models:  

Model 7230 Marquis VR

Model 7274 Marquis DR

Model 7232 Maximo VR

Model 7278 Maximo DR

Model 7277 InSync I Marquis

Model 7289 InSync II Marquis

Model 7279 InSync III Marquis

Model 7285 InSync III Protect CRT-D

 Another Medtronic ICD recall involved the Micro Jewel® II Model 7223Cx and the GEM® DR Model 7271.  The recall, which occurred on April 16th 2004, was made because these units could have defective high voltage capacitors. As a result of this defect, the capacitors may take longer than normal to charge. This delay in charging could cause a resultant delay in the delivery of the electrical pulse therapy.

 All of these recalls are considered Class I recalls by the Food and Drug Administration (FDA). Class I recalls are the most serious type because they involve a reasonable probability that continued use of the product will result in either serious injury or death.

 If you or someone you know has or had a Medtronic device implanted, and you would like to find out more, please click here and an experienced attorney will contact you shortly.

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