Monday, September 12, 2011

More Troubles for St. Jude's Riata Defibrillator Leads?

From the Minneapolis Star Tribune:
Researchers in Ireland have discovered a possible problem with a heart defibrillator component made by St. Jude Medical Inc. in which wires that run from the device to the heart may poke through the outer coating of their cable.

The study looked at 212 patients in Ireland who received St. Jude's Riata defibrillator lead and found that 15 percent had suffered such an "insulation breach," which could interfere with the device's life-saving therapy. Normal screening of the device or even X-rays may not pick up the breach, and patients would have no outward clue that their lead wire may be compromised.
It should be noted that the "study" referenced in this artice was actually an abstract published in the European Heart Journal's September supplement edition. I could not find it online yet, but a copy of the source abstract can be found on CafePharma, the medical device / pharmaceutical industry representative's anonymous messaging board.



Anonymous said...

Abstract referenced can be found here:

Another article suggesting Riata is a bigger problem was published in JCE in April:

Anonymous said...

While this single center study does bring into question the silicone insulation, I felt I must respond to your reference. I've always appreciated your candor and point of view but, come on, cafepharma? Who goes on that site but disgruntled industry employees. I never thought for a second physicians frequented it.

Keep up the good work but I'd stay away from that garbage dump of a website.