News & Resources

September 5, 2012. Category: Unsafe Medical Devices

Red Flags Raised over St. Jude Heart Devices

Over the last few weeks, two extremely negative news reports were made regarding defibrillator leads manufactured by St. Jude Medical.  Leads are used to transmit electricity to the heart from a defibrillator which delivers a shock if it detects problems with a patient’s cardiac rhythm.  Last week, the FDA ordered St. Jude Medical to do more research on the safety of both its older Riata generation of leads as well as the new generation of Durata leads.  The FDA also made the rare move of recommending patients who had received the Riata leads to go undergo additional testing to determine whether the device will fail. 

In late August, a highly anticipated study performed by cardiologist Dr. Robert G. Hauser was published in the EP Europace, a British cardiology journal, which stated cardiologists should stop using the leads until more is known about their safety. Dr. Hauser’s study focused on abrasion problems with both generations of the St. Jude leads.  He found 15 reports of problems with the Riata ST Optim and 37 for the Durata, and abrasion problems occurring within four years of being implanted.  Also, Dr. Hauser’s study found one lead failure that resulted in a patient’s death.  He recommended cardiologists stick with leads with proven safety records before implanting the leads made by St. Jude.

These two recent events come on the heels of a recall of the Riata leads in December 2011.  The recall occurred after an FDA study found one in five Riata patients had their device break through its insulation, causing dangerous electrical problems.  These serious safety concerns have led some doctors to remove the leads in some patients, even when they are still working.

This is just one more example of a company putting its bottom line ahead of patient’s safety.  It’s important that if you have received one of these devices, you take the necessary steps to ensure your safety.  If you aren’t sure if you have a St. Jude Medical heart defibrillator lead, you can contact your orthopedic surgeon, the hospital where the surgery took place, or our law firm can provide you with a release form so that we may obtain the brand name and model number of the lead you received.

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