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Medtronic gets FDA warning letter after inspection

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-Reuters

11/19/2009 - Medtronic Inc. confirmed on Wednesday it had received a warning letter from U.S. health regulators calling for corrective actions based on an inspection of its Mounds View, Minnesota, facility, the headquarters of its cardiac rhythm management (CRM) business, the company's largest unit.

The letter from the Food and Drug Administration comes in the wake of problems Medtronic has had with its leads that are used with implantable cardioverter defibrillators, known as ICDs.

The FDA issued the warning letter after it completed its inspection of the facility in August.

A spokesman said the letter addressed, among other things, corrective and preventive action, a review and documentation of field action recommendations, supplier qualification and controls, and medical device reporting timeliness.

The company, which competes with St. Jude Medical (STJ.N: Quote, Profile, Research, Stock Buzz) and Boston Scientific (BSX.N: Quote, Profile, Research, Stock Buzz) in the CRM market, said it will respond to the letter within 15 days, as required.

Medtronic said the FDA noted in its letter that the company's promised corrective actions appeared to be adequate to resolve the issues raised in the letter.

The company added that it has already begun to implement changes and put procedures in place related to each of the observations cited during the inspection, and additional actions that may be required will be in place as quickly as possible.

Medtronic has plants that make CRM products in Arizona, Puerto Rico and Switzerland. It also manufactures components in the Minnesota and will soon open a manufacturing facility in Singapore.

If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.
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