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.
Discover how the FDA measures the severity of a risk and take away the knowledge you need to create and administer a risk management file.
FDAnews’ Medical Device Risk Management: Beyond FMEA — New Tools to Assure Your Risk Management Program Meets New Standards conference this July offers immediate tools and techniques to manage and avoid possible risks. You can learn about five new risk management tools and four emerging new standards to transform your risk management program.
Learn how ETA, FTA, HACCP, PHA and HAZOP could be the keys to avoiding your next device disaster.
This is one conference you’ll never regret, that is unless you miss it! Register today, space is limited.