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Report: St. Jude Probed Riata Problems in 2005

Thu, 10/11/2012 - 11:48am
Mass Device

St. Jude Medical first learned of potential problems with its Riata pacemaker lead in 2005, 6 years ahead of its recall of the medical devices, the Wall Street Journal reports.

St. Jude Medical (NYSE:STJ) knew of potential problems with its Riata pacemaker lead, which it recalled in 2011, as early as 2005, according to FDA documents reviewed by the Wall Street Journal.

The Riata leads, which deliver rhythm-restoring shocks to heart muscles, are prone to so-called "inside-out" abrasion, in which the wires wear through their insulation and can extrude into the blood vessel that carries them. That creates a risk of malfunction or unintended shocks; some 80,000 patients are estimated to have the Riata leads, from about 120,000 sold before they were pulled from the shelves.

But St. Jude first received reports of inside-out abrasion with Riata leads in October 2005, according to the Journal, with an internal probe concluding in 2008 that the medical devices had "potentially serious insulation problems including inside-out abrasion," the newspaper reported. More than 13,000 patients have been implanted with Riata leads since July 2008.

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