(Reuters) - Shares of St Jude Medical Inc STJ.N fell 6 percent on Tuesday afternoon after a physician reported to U.S. regulators a failure of the company’s Durata brand lead wire connecting an implanted defibrillator to the heart in a single patient.
The report, posted in a U.S. Food and Drug Administration database, said the lead conductor became externalized, meaning the wire carrying electricity from the defibrillator to the heart was exposed through its insulation.
A St Jude spokeswoman told Reuters the company has reviewed the report but could not confirm any details. She said no physician has contacted the company or returned the lead, and the report contains no product serial number.
“We will make every effort to learn more about the report as quickly as possible,” St Jude spokeswoman Amy Jo Meyer said in an emailed statement. “To date, there have been no instances of externalized conductors on a Durata lead reported to St. Jude Medical.”
St Jude stopped selling an earlier-generation defibrillator lead called the Riata in 2010 after product failures were tied to patient deaths. The company has maintained that its Durata defibrillator lead is safe and effective.
Shares of St Jude were down $2.56, or 6.64 percent, at $35.98 in afternoon trading on the New York Stock Exchange. Shares of competitor Medtronic Inc(MDT.N) and Boston Scientific Corp (BSX.N) both rose 2 percent.
Reporting By Susan Kelly, Lewis Krauskopf and Debra Sherman; Editing by Gary Hill