FDA Warning to Medtronic on Defibrillators

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The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use in designated patient populations and to confirm the necessary training and experience for users of the device which is used to treat patients suffering from life-threatening Abdominal Aortic Aneurysms. The System was commercially approved in 1999 and the interim postmarket surveillance report, initially issued in 2002, has been filed on an annual basis until now.

The FDA has issued alerts and recalls affecting more than 337,000 defibrillators since 1990. There has been a reduced market for defibrillators since that time and a reported 8% decrease in the last 12 months.