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The QMN Weekly Bulletin
June 22, 2012 | Vol. 4 No. 25
Adverse Event Report Puts Safety of Durata Leads in Question
A report of an exposed conductor in a St. Jude defibrillator lead has renewed questions about the safety of some of the company’s cardiac products.
According to the report, filed in the FDA Manufacturer and User Device Experience (MAUDE) database with an incident date of April 18, a patient was injured after a conductor in a St. Jude Durata lead externalized, or was exposed through its insulation. The report was filed by a physician, but no other identifying information was included.
Durata leads were thought to be free of the design flaw that prompted St. Jude to recall roughly 227,000 Riata leads in 2011. At the time, the company acknowledged two patient deaths and one serious injury as a result of externalization.
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