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The law firm of Breit, Drescher & Imprevento, P.C. is pursuing litigation against Medtronic, Inc. related to the implantation, removal and replacement of these devices.
On February 11, 2005, Medtronic Inc. issued a statement to physicians advising them that over 80,000 implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are prone to battery depletion and failure. The battery shorting mechanism could cause the battery in these defibrillators to experience a rapid depletion of power resulting in the loss of device function. The particular devices affected were manufactured between April 2001 and December 2003 and include:
In Medronic’s February 2005 statement to physicians, Medtronic said the battery shorting problem can cause the batteries in these devices to become rapidly depleted, sometimes within hours or days. After the battery is depleted, the device will no longer function.
On April 16, 2004, Medtronic announced that it was recalling two other heart defibrillators because they have been linked to at least four deaths and one injury. Medtronic said that Medtronic Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 failed to charge properly which can result in the late delivery or non-delivery of cardiac shock therapy. Medtronic said that most of these devices were implanted in 1997 and 1998. About 1,800 are thought to be still in use.
These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmias, originating in the lower chambers of the heart. The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock. Medtronic said that with the suspect defibrillators, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or non-delivery of shock therapy. A delay or non-delivery of shock therapy can be life threatening.
The U.S. Food and Drug Administration (FDA) has been apprised of the defibrillator recall and has classified this action as a Class I recall. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
If you or a loved one have suffered injuries or have legal concerns related to these products, please contact us at (866) 669-0848. You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.
Legal Disclaimer: The above information is not intended to be or to replace legal advice from Breit, Drescher & Imprevento, P.C. Consult a Breit, Drescher & Imprevento lawyer for individual advice regarding your own possible Medtronic litigation. Confer with your doctor or other qualified medical professional before removing any device and before changing your own personal healthcare regimen.
Breit Drescher & Imprevento, P.C.
1000 Dominion Tower
999 Waterside Drive
Norfolk, VA 23510
Toll Free: 800.807.6060
Phone: 757.622.6000
Fax: 757.670.3939
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