Medtronic Releases Important Communication Notifying Physicians of Faulty Battery Reading in Its EnRhythm Pacemaker
February, 2010 – Medtronic Inc., one of the world’s largest manufacturers of pacemakers, defibrillators and other medical devices, is asking physicians to stop “unnecessarily” replacing the EnRhythm and EnRhythm MRI pacemakers. In a letter distributed to physicians worldwide, Medtronic has acknowledged that the two models are defective, but pose no health risks to patients. The defects relate to incorrect low-battery warnings.
Following an in-depth investigation of battery-related issues, Medtronic has announced it will fix the problem by midyear using a software update. According to the announcement, unnecessary pacemaker replacements stem from confusion about battery-voltage readings.
The software program that will be used to fix the faulty device may slightly reduce battery longevity; however, the manufacturer states the two models are still expected to last anywhere from 8 to 10 years.
Although, Medtronic claims that EnRhythm and EnRhythm MRI pacemakers do not pose any safety risks to patients, if you have suffered a serious injury while using EnRhythm or EnRhythm MRI, please contact an experienced personal injury attorney right away. You may be entitled to receive monetary damages for your pain and suffering.
To learn about recent recalls of faulty medical devices, please refer to the articles below.
Pacemaker & Defibrillator Recall
The United States Food and Drug Administration has determined that the safety
advisory was issued on June 17, 2005 as a pacemaker and defibrillator recall.
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Medtronic Incorporation has warned physicians to cease using their pacemakers after they discovered faulty wiring in some models.Read more on Medtronic. |
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Two safety communications were issued to its customer physicians concerning
important safety information related to its medical product devices, including defibrillators.
The Recall communication on June 17 related to both the defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices. The safety advisory communication
on June 24, 2005 related to the safety of cardiac resynchronization therapy devices.
"Pacemaker Recall" Clarification – September 28, 2006
The Heart Rhythm Society has been working closely with the FDA and the manufacturers of cardiovascular medical devices
to clarify any confusion associated with safety warnings issued for cardiovascular medical devices.
Although there remains a serious risk to patients implanted with any of the affected medical devices, the FDA is
considering softening their rhetoric with regard to the issuing of warnings. The Heart Rhythm Society has suggested that the term
"recall" be replaced with some other phrase such as "advisory notice" or "safety alert." Such a change has been welcomed
by the FDA, the American College of Cardiology Foundation, the International Coalition of Pacing and Electrophysiology
Organizations and the American Heart Association.
The clarification has been recommended to combat the high volume of patients implanted with pacemakers and
ICDs requesting the removal of their device for fear of malfunction. As it is, only a small percentage of
devices have proven faulty, and the surgery to remove an implanted device could potentially cause more of a
health threat, especially if said device is functioning properly. It is believed that a softening of the rhetoric
could alleviate such unwarranted concerns.
Recall Issued – April 11, 2007
Another recall has been issued for some 73,000 defective ICD and CRT devices. Batteries designed to last for a
minimum of two years were failing after as little as three months. The rapid depletion of battery-life could potentially
result in premature device failure. Of the 73,000 (+) devices involved in the recall, 19 defective models have been found.
No serious injuries or deaths have been reported as a result of the defects.
Guidant Pacemaker and Defibrillator Products
There are a number of large companies that manufacture and distribute implantable cardioverter defibrillators (ICD) and
devices for cardiac resynchronization therapy (CRT). These devices are used to treat abnormalities in
heart rate and heart rhythm in patients who have heart disease or heart failure. The devices are designed to
be implanted in the chest area and monitor heart function. If an irregularity is detected, then an
electrical impulse (shock) or a series of impulses are delivered to various parts of the heart to restart
normal function.
Pacemaker-Related Deaths
Heart disease continues as one of the biggest killers in the United States. Heart failure, also known as
cardiac arrest, occurs when the heart stops pumping blood properly. This illness leads to 200,000 to
400,000 deaths per year.
The pacemaker devices are designed to extend the lives of heart disease patients,
but if a defibrillator is defective, it could have devastating effects, including patient death.
When the devices are defective, either the irregularity of the heart rate is not detected
or the proper electrical impulses for treatment are not delivered to the heart. If the proper therapy
is not provided, the heart can cease proper functioning and the patient could perish or suffer
serious injuries due to lack of proper blood flow.
It is the defibrillator manufacturer's responsibility to maintain the highest quality standards for their
pacemaker and defibrillator products and insure that if any quality issue arises,
immediate steps are taken to protect the patients.
About the Sponsors of this Pacemaker and Defibrillator Information Website
If you or a loved one has been injured due to a defective pacemaker or defibrillator product, you
may be entitled to compensation. The sponsors of this website are attorneys who specialize in helping those who have been injured
by defective products. Please contact our offices today so that one of our lawyers may answer any questions that you
have and provide a free case review if needed. Our toll-free number is 888-255-AWKO (2956).
If warranted, we can file a lawsuit to help obtain the proper compensation.
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