One adverse event has reignited product safety worries surrounding St. Jude Medical (STJ). The medical device maker�s share price slumped more than 6% Tuesday afternoon following a report in a government database of a single adverse event involving its key implantable defibrillator lead, known as Durata.
Leads are wires use to attach implantable defibrillations to heart tissue. St. Jude has had problems with an older lead called the Riata, which is no longer on the market. But doctors and investors worry that St. Jude�s newer Durata lead may have the same problems.
According to DJ�Newswires, �a report dated April 18 in the FDA’s Maude database of adverse events stated that a fluoroscopy of St. Jude’s Durata lead revealed protruding cables, a problem seen in some of the older Riata leads.�
The event was reported by a physician, and the report wasn’t sent to the manufacturer. It was received by the FDA on May 2.
Talk about bad timing. Last week, Barrons.comweighed in bullishly on St. Jude�arguing that product safety concerns weighing on the stock should be put to rest in the next year.
St. Jude has defended the Durata. In remarks to DJ Newswires, company spokeswoman Amy Jo Meyer�said�that to date, there have been no instances of protruding cables in the Durata lead reported to St. Jude and was unable to confirm�any details based on the event description at this time.
St. Jude shares fell 6.2% to $36.16 . The stock is down more than 25% in the past 52 weeks.
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