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
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