Safety Concerns Over Defibrillator Wires

posted on:
November 12, 2007


Shares of medical device maker St. Jude Medical could face pressure Monday on a media report that raised safety concerns over some of its defibrillator wires. 

The Wall Street Journal reported Monday that in rare instances, the company's Riata line of defibrillator leads are poking holes through the hearts of cardiac patients rather than remaining attached to the heart wall.

The leads connect a patients heart to an implantable defibrillator, which helps maintain a proper heart rhythm. The cases have been reported to the Food and Drug Administration.

The newspaper said the most recent cases involve the accounts of four patients and are expected to be posted online Monday by the medical journal Pace.

In October, Medtronic Inc., recalled its Sprint Fidelis lead wires after conceding that the device broke more often than expected and said five deaths may be attributed to the failures. The consumer advocacy group Public Citizen has said the FDA received 27 failure reports on Sprint Fidelis leads in the first two months of 2006. That figure surged to 152 reports during the first two months of 2007.

St. Jude said Monday it has sent a response to the Pace journal, which is expected to be published in the December issue, reaffirming the Riata leads performance and safety. The company said its data show that the incidence rate of perforations with Riata is below or at the low end of what has been reported in clinical literature.

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