There is more freighting news for heart patients implanted with Durata defibrillators made by St. Jude Medical. As a Florida lawyer who sues medical device companies I am very concerned that both the FDA and leading cardiologists are warning heart surgeons to stop using St. Jude’s components due to long-terms safety concerns.
A heart defibrillator is made of two major parts: a battery powered heartbeat monitor and a lead. The lead sends information to and from the heart and delivers a jolt of electricity when it detects an abnormal heart rhythm. The batteries have to be changed out every five years and it is relatively easy to do. But changing out a corroded lead is very dangerous. That is why lead manufacturers have focused on coming up with long term solutions.
Dr. Robert G. Hauser of the Abbot Northwestern Hospital in Minneapolis published a study in the prestigious Europace Oxford Journal finding that the material used by St. Jude to coat their lead wires breakdowns prematurely causing their defibrillators to suddenly fail. If a defibrillator lead fails it can be deadly. So far, there have been 20 deaths linked to St. Jude Medical device failures.
St. Jude started using the coating, known as Optim, years ago to prevent the leads from abrasion. But according to Dr. Hauser and the FDA, Optim is subject to failure. Durata implants have been used in over 278,000 patients around the world.
St. Jude is quick to defend their product and claims that Optim is 50 times stronger than silicone. Currently they are monitoring just 11,000 patients. We believe that they should be closely monitoring every patient that has this device.
Based but the FDA and Dr. Hauser’s recommendations, our heart device claims lawyers recommend that any patient who has received a St. Jude device contact their health care provider immediately. The FDA recommends that certain imaging test be performed that can identify if the device is failing. This applies to both the Riata, Riata ST and Durata heart devices.
If you have a problem with your heart device lead you should consult with your doctor, report the problem directly to the FDA Medical Device Reporting Center and consult with an experienced and qualified medical device injury lawyer to protect your legal rights.
St. Jude Medical recalled the Riata leads on Nov. 28, 2011, due to insulation failure. St. Jude stopped selling Riata leads in late 2010. Over 227,000 Riata leads had been distributed worldwide and as of 2011, approximately 79,000 U.S. patients still have Riata leads.