Weak Device Monitoring Blamed for Tardy St. Jude Riata Lead Recall

Many of the problems caused by St. Jude Medical Riata implanted defibrillator leads could have been prevented if more initiative had been taken to monitor its safety track record in patients.

According to a Bloomberg report citing a recent study published in New England Journal of Medicine, the Riata was recalled in 2010 due to the likelihood the metal leads used to send power to an implanted cardiac defibrillator would break free of their insulation coating. When defibrillator leads detach, it causes the life-saving heart device to stop working. If a defibrillator ceases to deliver a regulated shock to a patient’s heart, it could prevent a life-saving treatment to occur, putting a patient’s life at risk.

A cardiologist at Minneapolis Heart Institute told Bloomberg the Food and Drug Administration must require medical device companies like St. Jude to conduct post-market studies on new products to track potential complications with it. Before problems with the St. Jude Riata were well-known, it’s possible close to 100,000 people were outfitted with these cables leading to their heart defibrillator. As many as 79,000 St. Jude Riata leads are still inside patients despite this known and very serious risk.

St. Jude recalled the Riata leads last year but stopped marketing them in December 2010 after numerous reports indicated wires were breaking through the insulated coating on them. In addition to the lack of needed therapy a lead like the Riata will not deliver when it breaks from the defibrillator, a broken lead is also like to cause internal damage to tissues and organs, including lacerations to the heart.

Further complicating the situation caused by the defective Riata leads is the lack of guidance data, informing patients and surgeons of the best course of action when encountering a person with these wires implanted. In some cases, the lack of a standard course of action results in more experimental surgeries and puts more patient lives at risk.

Despite the call for more information, St. Jude defended its record-keeping and adherence to safety tracking, telling Bloomberg the company has “the most active post-market surveillance program” among other companies competing with it for defibrillator lead sales. This claim was countered by Dr. Robert Hauser, the Minneapolis cardiologist cited previously. He told Bloomberg there is technology available allowing doctors and medical device companies to track the performance of devices like the Riata in real time but it isn’t until thousands of them are installed when safety data becomes available.

Problems with the Riata leads were preceded by similar complications caused by the Sprint Fidelis cardiac defibrillator leads, which were also prone to failures when they separated from the devices or broke free of their insulated housing.

The New England Journal of Medicine critique of the monitoring of the Riata leads suggests companies marketing these devices should be required to follow the performance records of these devices earlier and to report those findings to the public in some manner. St. Jude has now begun marketing the Durata defibrillator lead as a follow-up to the failed Riata.

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