Defibrillators May Cause Damage to Patients
When an individual suffers from heart fibrillation they often undergo a surgical procedure where an implanted cardio-defibrillator (ICD) is given to the patient. The ICD defibrillators act as a "heart normalizer" and restore the heart back to its normal rhythm. The defibrillators are considered a technological advancement in the medical community and have helped save lives for patients suffering from life-threatening arrhythmia in the heart.
Guidant Failed to Disclose Known Flaws in its Defibrillators for Three Years
Guidant came under fire in the spring of 2005 after The New York Times reported that it failed to alert physicians and heart patients about a potential problem with the VENTAK PRIZM DR model defibrillator.
Since then, Guidant has admitted to knowing of malfunctions in its ICDs for three years but has continued to sell the defective ICDs, allowing them to be surgically implanted in patients, knowing that these patients were at risk for device failures that could lead to severe complications including death.
In the article, the defective defibrillators being produced in 2002 may have been defective and the company was allegedly aware of this. In addition Guidant did not inform doctors and patients of the defect until it knew that the New York Times article would be published.
The FDA Recalls 50,000 Guidant ICDs
The Food and Drug Administration (FDA) oversees the safety of medical devices and on June 17, 2005, issued a nationwide recall of nearly 50,000 Guidant ICDs. These devices may develop an "internal short circuit without warning," resulting in failure to deliver a shock when needed and are subject to memory errors. The company then issued an additional safety warning that some of the company's models were unsafe and may malfunction.
Presently, Guidant is responding to Department of Justice administrative subpoenas requesting information related to faulty manufacturing, as well as FDA observations regarding manufacturing and quality control processes. New York Attorney General Eliot Spitzer filed suit against Guidant on November 3, 2005, stating, "We wouldn't permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device."
Devices Subject to FDA Recall
As part of the FDA's oversight of medical devices the Administration has classified three classes of recalls, Class I, II, and III. Class I recalls are the most serious type of recall and indicates that there is a reasonable chance that the product will cause serious health problems or death. The FDA issued a Class I recall of the following Guidant devices:
* CONTAK RENEWAL (Model H135)
* CONTAK RENEWAL 2 (Model H155)
* CONTAK RENEWAL 3 AVT (Models M150, M155)
* CONTAK RENEWAL 3 AVT HE (Models M157, M159)
* CONTAK RENEWAL 4 AVT (Model M170, M175)
* CONTAK RENEWAL 4 AVT HE (Models M177, M179)
* VENTAK PRIZM 2 DR (Model 1861)
* VENTAK PRIZM AVT (Model 1900)
* VITALITY AVT (Model A135, A155)
In a Class II FDA, recall there is a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems. Accordingly, the FDA has issued Guidant several Class II recalls for these products:
* CONTAK RENEWAL 3 (Model H170, H173, H175)
* CONTAK RENEWAL 3 DS HE (Model H177)
* CONTAK RENEWAL 3 HE (Model H177, H179)
* CONTAK RENEWAL 4 (Model H190, H195)
* CONTAK RENEWAL 4 HE (Models H197, H199)
* PRIZM 2 DR (Model 1861)
* RENEWAL RF (Model H230, H235)
* RENEWAL RF HE (Model H239)
These recalls have been issued because the products pose very serious health risks or death for patients. The FDA is continuing to investigate other defibrillators on the market. It is advisable for individuals who received the faulty defibrillators to locate legal consultation.
Source: Free Articles from ArticlesFactory.com
Related Tags: to, patients, cause, damage, may, defibrillators
LegalView hosts an array of pharmaceutical information portals with more information on the Guidant Defibrillator scandal at http://guidant.legalview.com , as well as information on the Digitek digoxin risks or the potential for a Chantix recall. Visit LegalView's homepage at http://www.LegalView.com/ , to learn more. Your Article Search Directory : Find in Articles
Recent articles in this category:
- Dental Insurance For Individual Can Be Of Help At Time
Dental problem may cost one a lot of money and pain. But, practicing a reasonable care could decreas - Personal Trainer For Perfect Health
There is a general misconception that need for a fitness trainer comes for novice or from those who - Varicose Veins - Causes, Symptoms, Treatment
The majority of people after thirty notice the changes that appear with the maturing. In this case t - Scenar Therapy - Self-treatment Or Healing Partnership
Do you want to learn about a device which will help you to ease your pain? If you get this kind of a - Scenar - 5 "no, Nos" Of Scenar
Are you fed up with the pain in your body? Various parts of our body seem to ache due to different r - Scenar Device - 5 Tips On Travelling With Your Scenar (skenar) Device
You might be aware of scenar which has become quite popular these days. This is actually the acronym - Scenar Therapy - How To Treat Your Pet With Scenar
There are many alternative methods of treatment that are being invented these days. Lots of people a - Your Options For The Treatment For Appendicitis
Appendicitis is considered to be a surgical illness. Due to its severe character, the treatment for - How To Choose The Right Copd Medication
Chronic obstructive pulmonary disease or COPD does not have any cure. But with the help of medicines - Septic Arthritis: Infectious Agents Penetrate Joints' Spaces
Another major type of arthritis is septic arthritis, which is also known in various terms like: pyog
Most viewed articles in this category:
- Drugs - the Last Alternative for Adhd in Kids
Anyone over the age of thirty who has grown up with ADHD understands that there was not much help av - Foods To Eat To Gain Weight
Malnutrition has the same degree of problem as obesity. There are people who are too skinny, they fi - Understanding Postpartum Clothing
The same way most pregnant women dream of the day when they will begin showing for wearing maternity - Kegel Exercising for Bladder Control and Enhanced Sexual Pleasure
Kegel exercises strengthen the muscles of the pelvic floor, thereby improving the urethra and/or rec - The Use Of Weight Loss Herbs
Nothing has garnered more attention in today's world than the success or failures of weight loss pro - A Simple Acid Relux Cure
Many people today are afflicted with heartburn. If they eat food that is too spicy, they get heartbu - Five Effective Household Back Pain Treatments
Back pain treatment comes in lots of forms, from exercise to pain mediction. Standard and most wides - Herbal Remedies - Can They Cure What Ails You?
You've probably heard about herbal remedies before and how they can treat a variety of health proble - Natural Relief for Tinnitus - What are your Choices
Natural Relief For Tinnitus - Alternative Options Did you know that there are an estimated 50 t - Birthing Around the World
Since ancestral times, different cultures showed off different customs and beliefs around the miracl