The Medtronic Recall: A Breach of Public Trust in Defective Medical Devices
Medical devices used in the defibrillation of the heart are known as defibrillators.
Defibrillators provide an electric shock to stop the heart and encourage it to restart its
regular rhythm.
Defibrillators have seen many technological advances over the years. There are currently
several different types of defibrillators that are commonly used to by doctors to treat
patients with cardiac concerns:
Internal Defibrillators- These defibrillators are most commonly known as implantable
cardioverter defibrillators, internal cardiac defibrillators (ICDs) or pacemakers. Designed
to provide instant defibrillation to high-risk patients, these devices are planted within the
patient. Internal defibrillators constantly monitor a patient's pulse rate and heart rhythm.
If a problem occurs, the implanted device can immediately initiate defibrillation.
Automated External Defibrillators- These defibrillators are designed for portability.
An automated external defibrillator (AED) is usually shaped like a briefcase and contains a
control computer, a battery, and electrodes. To use, electrodes are placed on the patient
and the computer assesses the patient's heart rhythm. The AED then determines the
appropriate power level and signals that a shock is needed. Whoever is operating the
AED then pushes a button to administer the shock. A unit in good working order will not
allow a shock if the patient does not require it.
Cardiac Resynchronization Therapy Defibrillators- These defibrillators are designed
for patients who need congestive heart failure therapy. A cardiac resynchronization
therapy defibrillator (CRT-D) is a special pacemaker that is implanted in the patient to re-
coordinate the heart's ventricles. CRT can greatly improve the heart's condition and
reduce the need for hospitalization.
Defective Defibrillators
Defibrillators can save the life of someone who is experiencing cardiac arrest. However,
if these devices are not working correctly, it can be extremely dangerous and sometimes
fatal for the patient. Over the last few years, there have been a staggering number of
problems with defective defibrillators. Several manufacturers have issued a huge number
of recalls on defibrillators because of multiple defects, such as battery shorts and
electrode failures. Medtronic is a good example.
Medtronic Defective Defibrillators
Medtronic Inc is the largest manufacturer of pacemakers and implantable caridoverter
defibrillators (ICDs). As such, their products are implanted and used on thousands of
patients every single year. Unfortunately, many of these patients have been victim to the
defects that plague Medtronic defibrillators.
Between April 2001 and December 2003, Medtronic manufactured several different
models of implantable cardioverter defibrillators and cardiac resynchronization therapy
defibrillators that had a battery defect. The battery defect was a short that led to advanced
battery depletion, which caused the device to quit functioning within a matter of hours.
This type of defect is extremely dangerous for patients who had been implanted with
Medtronic devices. Without a functioning defibrillator, patients were at great risk.
Unfortunately, this information was not made public immediately.
Medtronic first discovered the defective defibrillators in 2003 during internal quality
testing. Instead of going public with their findings, Medtronic made an error in judgment
and simply decided to alter their battery design. Their error soon became evident in the
spring of 2004 when problems began among patients who had received the defective
defibrillators.
Medtronic waited until February of 2005 to begin notifying physicians of potential
defibrillator problems. By then, Medtronic defibrillators had been implanted in patients
across the world. It is estimated that 87,000 people received potentially defective
defibrillators. More than 75% of the affected models were implanted in the United States
alone.
Physicians were instructed by Medtronic to contact a list of potentially affected patients
to help monitor the situation and discuss options. As of September 2005, more than
13,000 people worldwide have had the Medtronic devices surgically removed. Any time
this type of surgery is performed, patients are at risk for infection and other types of
complications.
Understandably, many people are upset about the situation and have accused Medtronic
of knowingly marketing and selling a defective product. As a result, many lawsuits have
commenced to hold Medtronic accountable for their actions.
These are the ICD and CRT-D Medtronic models that were manufactured between April
2001 and December 2003. These devices have known battery defects:
- Marquis VR (ICD)
- Marquis DR (ICD)
- Maximo VR (ICD)
- Maximo DR (ICD)
- InSync Marquis (CRT-D)
- InSync II Marquis (CRT-D)
- InSync III Marquis (CRT-D)
- InSync III Protect (CRT-D)
Other Medtronic models that have been recalled due to a malfunction that can cause fatal,
late, or non-delivery of cardiac shock were implanted between 1997 and 1998. These
devices include:
- Micro Jewel II (ICD)
- Gem DR (ICD)
Other Defective Defibrillators by Medtronic
Medtronic's implantable cardioverter defibrillators and cardiac resynchronization therapy
defibrillators were not the only devices that contained defects. At the end of February
2005, Medtronic also announced a voluntary recall of two different automated external
defibrillators.
One model, the Lifepak 500, displayed error messages, while failing to analyze patients'
heart rhythms. Consequently, the defect also prevented the device from delivering the
necessary shock to the patient. The other model, the Lifepak 12, contained defective
cables, which caused the paddles to deliver inappropriate energy levels to the patient's
heart.
Ongoing Litigation Against Medtronic
Deaths and injuries have been connected to Medtronic's defective defibrillators and to
date many lawsuits have been filed against the company. The majority of these lawsuits
express concern over the 'design, development, testing, manufacturing, licensing,
assembly, distribution, marketing, and sale' of specific Medtronic defibrillators. The
plaintiffs in these lawsuits include people who were implanted with the device and their
family members.
An example of such litigation is the class action lawsuit that is now occurring in Canada
against Medtronic Inc. and Medtronic of Canada Ltd. For more information on the class
action suit and the law firms who are handling the suit, visit http://www.medtronic-
classaction.com.
Some physicians and surgeons have also had lawsuits filed against them. A former
employee of Medtronic alleges that doctors were given money in exchange for using and
promoting Medtronic products.
Medtronic Timeline (For Easy Reference)
- 1996 to 1998- Medtronic was sited three times by the FDA for failing to conduct product
performance tests over long periods of time.
- 1997 to 1998- Medtronic devices (Gem DR and Micro Jewel II) were implanted in
patients. These devices were linked to at least 4 deaths and one injury. They were later
recalled. Approximately 1,800 of the potentially defective defibrillators are thought to
still be in use.
- 2001 to 2003- Medtronic manufactures several different models of implantable
cardioverter defibrillators and cardiac resynchronization therapy defibrillators that had a
battery defect, posing great risk to patients.
- 2003- Medtronic discovers the battery defect during internal quality tests. They do not
make their findings public. Instead, they continue to market and sell devices with known
problems from their old stock.
- 2003- Medtronic alters the battery design and submits it to the FDA for approval. The
FDA approves the new design.
- 2004- Patients and physicians begin to report problems with the defibrillators that were
manufactured between 2001 and 2003.
- 2005- Medtronic issues a notice to physicians about the possible battery defect with the
ICD and CRT-D devices. They recommend that doctors speak with their patients and
monitor them carefully.
- 2005- The FDA declares the notice a recall, stating that the malfunction could cause
'serious adverse health consequences or death' if not detected.
- 2005- Medtronic is forced to voluntarily recall two different automated external
defibrillators because of device defects: the Lifepak 500 and the Lifepak 12.
- 2005 to 2006- Several different lawsuits are filed against Medtronic and physicians on
behalf of patients who wore the device and their families.
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