Carmel, CA Defibrillator Leads A Worry To The FDAby Richard Kuehn on 08/20/12
The Food & Drug Administration (FDA) has ordered a review be conducted on the Riata defibrillator leads made by St. Jude Medical Inc. which were recalled last December. The FDA also told the company they want it to beef up studies it is doing on a similar product called Durata. These defibrillator leads are still on the market and the FDA warned that the devices look too similar to the ones which were recalled and could possibly lead to life-threatening failures like the Riatta. If you have a defibrillator, I would urge you to contact your physician to find out what types of leads are being used. A recent study conducted by St. Jude found that problems occurred in a whopping 19% of 700 patients analyzed that had the leads which have been recalled. The FDA is now asking that St. Jude routinely X-ray patients enrolled in its current study of the newer leads to detect any potential insulation problems.