St. Jude: New Device’s Failure Unrelated to Recalled Devices’ Flaw

St. Jude Medical claims that a defective device reported to the U.S. Food and Drug Administration last month did not have the same flaw as an older line of devices that was recalled last year.

St. Jude Medical, Inc., said Friday that its defibrillator lead that was removed from a patient in April and reported to be damaged did not have the same critical flaw as an older but similar line of recalled devices.

Leads are wires that connect defibrillators to the heart.

In May, a physician reported to the U.S. Food and Drug Administration (FDA) that one of St. Jude’s Durata leads failed after it was implanted in a patient. The report, which the FDA received on May 2, claimed that the lead had cables protruding through its insulation lining—a problem seen in some of the company’s Riata leads, which were recalled last year, according to a report by Dow Jones Newswires.

St. Jude subsequently analyzed that particular lead and the medical records of the patient from whom the failed device was removed, and it found that the lead was damaged because it was scraping against another object within the patient's body—either a hardened heart valve or another lead that had been implanted in the patient. Such external abrasion is a “known cause of failure across all cardiac leads in the industry” and is “different from the inside-out abrasion seen with externalized conductors observed in some Riata leads,” the company said.

St. Jude stopped selling its Riata line of leads in December 2010 and recalled them a year later amid reports of their failure. According to a Reuters report, the Riata leads failed because the silicone coating around the wires eroded at a higher-than-expected rate, causing wires to protrude out of the leads.

Durata replaced Riata, and the insulation coating around the Durata leads was designed to prevent the problems seen in the older leads.

St. Jude’s shares fell 6 percent to $36.23 earlier this month when media reports about the Durata lead failure emerged. Shares of the company’s stock were trading up 2.6 percent at $37.90 on Friday, following St. Jude’s announcement about its findings related to the Durata lead failure and at $37.70 early Tuesday afternoon.

Little Canada-based St. Jude is among Minnesota’s 15-largest public companies based on revenue, which totaled $5.6 billion in 2011.