St Jude Says Adverse Event Has Not Been Reported to Company

A spokesperson for St Jude Medical STJ, responding to earlier FDA filing on Durata defibrillation lead says: "We have reviewed the adverse event report, but as stated in the filing, the event has not been reported to the company nor has the lead been returned. The report indicates that it was filed by a physician, but does not provide the device serial number, the name of the physician or the institution, which would enable us to learn more about the circumstances. We are not able to confirm any details based on the event description at this time. We will make every effort to learn more about this report as quickly as possible. To date, there have been no instances of externalized conductors on a Durata lead reported to St. Jude Medical." St Jude Medical shares are trading down 6.5% on Tuuesday at $36.04.