Defective Medical Device

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Cardiac Resynchronization Therapy and Implantable Cardiac Defibrillators Cardiac Resynchronization Therapy (CRT) pacemakers and Implantable Cardioverter Defibrillators (ICDs) both deal with the science of heart disease. Recently Guidant Corp. and Medtronic, Inc., two major manufacturers these medical devices have faced recalls because of serious design flaws in their products.

Medtronic Device Alert
Medtronic, Inc., a Minneapolis-based self-proclaimed leader in medical technology, pain alleviating, health restoration, and life extension for millions of people around the world alerted physicians in February of 2005 that some of their implantable heart devices are subject to differing battery failures, effectively negating the device.

Ironically, in 2005, Guidant Corporation recalled over 50,000 of its implantable heart devices due do a failure to deliver a shock when needed, posing serious cardiovascular risk to the patient.

Medtronic Device Failure
On February 11, 2005, the Food and Drug Administration (FDA) reported, “Medtronic, Inc., (NYSE: MDT) today said it is voluntarily advising physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that nine batteries have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function (1).”

Affected Devices:

Implantable cardioverter-defibrillator models:
Marquis ® VR 7230
Marquis ® VR 7274
Maximo™ VR 7232
Maximo™ DR 7278

Cardiac resynchronization therapy defibrillators:
InSync ® I Marquis ®
InSync ® II Marquis ®
InSync ® III Marquis ®
InSync ® III Protect 7277
InSync ® III Protect 7289

Understanding Heart Failure
Heart failure affects 4.6 million Americans with some 550,000 new cases diagnosed each year. It is the leading cause of hospitalization for those aged 65 and older (2). Heart failure does not mean the heart has stopped working, but rather that the heart is pumping blood at a lower, slower rate. This leads to an increase of pressure inside the heart, the result of which is the heart’s inability to pump enough oxygen and nutrients throughout the body to meet its needs.

The term heart failure also encompasses conditions such as ventricular tacycardia and fibrillation in which the heart beats extremely fast and without enough pressure to adequately supply the body’s needs. It is when the heart no longer functions properly that many look to medical devices to correct the dysfunction, which is where cardiac resynchonization therapy and implantable cardioverter defibrillators are effective.

Cardiac Resynchronization Therapy and Implantable Cardiac Defibrillators
Cardiac resynchronization therapy (CRT) pacemakers and implantable cardioverter defibrillators (ICDs) both deal with the science of heart disease. CRT devices are an advanced form of pacemakers; their function is to coordinate the ventricles (the main pumping chambers) of the heart to beat in an efficient, cohesive manner. Some sufferers of heart disease have ventricles which beat against one another and are incapable of producing the necessary strong muscular contractions of a healthy heart. CRT pacemakers largely alleviate this problem.

ICDs are similar to CRT devices in that their primary function is also to regulate the beating of the heart. ICDs deal with ventricular tacycardia and fibrillation – when the heart beats so fast that blood is not pumped throughout the body. This condition can also lead to cardiac arrest and death. ICDs monitor the rhythm of the heart and will deliver an electric shock directly to the heart if it begins to beat dangerously fast. 90% of today’s cardiac arrests are prevented by ICDs (3).

What should I do if I received on these devices?
Always consult with your physician for medical advice. If you received one of these devices and are concerned about the possible health risks, contact our law offices immediately for a free and confidential case evaluation.

Sources:

Medtronic Issues Notification Regarding Certain Implantable Defibrillator Models fromwww.fda.govaccessed 08/11/05.

WebMd’s Guide to Heart Disease fromwww.webmd.comaccessed on 06/27/05.

Preparing for Heart Failure Device Therapy accessed on 06/27/05.

This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice you should always consult with your physician.
Marquis ® and InSync ® are registered trademarks of Medtronic, Inc. and are used here only to identify the products in question.

This law firm is not associated with, sponsored by, or affiliated with Medtronic, Inc., Guidant Corporation, the Food and Drug Administration, or WebMD.

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