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Last Updated: November 1, 2007

MEDTRONIC LEADS

ABOUT LEADS

Leads are thin electronic wires used with implantable cardiac devices, such as defibrillators. The wires connect the device directly to the heart.

The following leads are subject to the October 2007 recall:

Brand Model #
Sprint Fidelis 6930
Sprint Fidelis 6931
Sprint Fidelis 6948
Sprint Fidelis 6949

ABOUT DEFIBRILLATORS

Defibrillators are medical devices implanted in the chest and connected directly to the heart to monitor the heart rhythm. They provide electrical shocks as needed to restore a normal heart rate. These devices are used in patients at risk of sudden cardiac arrest.

The defibrillators affected by the October 2007 recall are implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). Not all Medtronic defibrillators are subject to the recall – only those that use certain model numbers of Sprint Fidelis leads.

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THE DEFECT

On October 15, 2007, Medtronic announced a recall of some of its leads because they are prone to fracture. If an implanted lead breaks, the defibrillator may deliver unnecessary electric shocks or it may not operate at all when the patient needs to be shocked. The consequences could be fatal. Medtronic will no longer make or sell these particular leads and is requesting that all unused recalled leads be returned to the company. As for the patients who already have the defective leads implanted, surgical removal is not advised because the risks of surgery usually outweigh the risk that the lead will break. For more information, see What are my Options?

ABOUT MEDTRONIC, INC.

History: Founded in 1949

World Headquarters: Minneapolis, Minnesota

Locations: 250 manufacturing facilities, sales offices, research centers, education centers, and administration facilities with customers in more than 120 countries worldwide.

Employees: Employs more than 36,000 people worldwide

Net Sales:

2007 - $12.3 billion dollars so far
2006 - $11.3 billion dollars
2005 - $10 billion dollars
2004 - $9 billion dollars
2003 - $7.7 billion dollars

The Law Firm of Howard L. Nations has the resources, experience and commitment required to demand justice for people who have been injured by defective Medtronic products. If you or someone you know has a recalled Medtronic lead implanted, contact us for a free case evaluation by one of our pharmaceutical attorneys.

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