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Defibrillator Lead Concerns Hit St. Jude

November 21, 2007

An editorial in Pacing and Clinical Electrophysiology is turning the spotlight on St. Jude Medical’s Riata family of defibrillator leads, pointing to possible manufacturing concerns with newer leads. This scrutiny follows a recent recall of Medtronic defibrillator leads.

According to the editorial, in the past year, there have been reports of perforations with both active and passive fixation St. Jude Riata implantable cardioverter defibrillator leads.

The lead is “particularly troublesome” not only because of the perforation but because of its late presentation, author Stephen Vlay of Stony Brook University’s Division of Cardiology said.

Sometimes the lead perforation does not come to clinical attention until it is well beyond the right ventricular free wall, he said. Furthermore, with the Riata, the movement continues until the lead protrudes out several centimeters into adjacent tissue. This could cause ventricular asystole if a patient is pacemaker dependent or the device fails to successfully defibrillate, both resulting in sudden death.

According to Vlay, there is a legitimate concern that the problem may be due to an inherent design flaw.

St. Jude submitted a response to the editorial citing data from its returned product analysis, as well as from previously unpublished active, prospective registries, showing the rate of perforation with Riata is below or at the low end of what has been reported in clinical literature for incidences of perforation for transvenous defibrillation leads.