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.
Devices & Diagnostics Letter