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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

FDA Data Indicates that St. Jude Lead Wire has Safety Issues

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Individuals that suffer from heart conditions requiring treatment with endocardial defibrillation leads have new reason to be concerned over St. Jude Medical’s products. Months ago, St. Jude Medical was required to recall its Riata defibrillation leads due to a defect that causes serious health consequences, including death. Now the product that replaced the Riata system appears to suffer from the same problems. In June, a physician filed a report with the FDA indicating that St. Jude’s Durata defibrillation lead exhibited the exact same defect that were observed in the Riata.

The common problem between these two defibrillation devices has to do with the insulation coating around the lead wires. With the Riata product, the silicone insulation material covering the defibrillation leads exhibited premature abrasion. When that occurred, the conductors inside the leads became “externalized”, a defect which can cause electrical dysfunction. Because of this defect, St. Jude ceased sale of the leads in 2010 and the product was completely recalled in November of 2011.

St. Jude then released the Durata defibrillation lead system in attempt to resolve these issues. The Durata used a new insulation coating, called “Optim, which was supposed to prevent the defect seen in the Riata products. Until now, no cases of externalized Durata wires had been reported. But now a report made to the FDA shows that the problem may not be solved. According to an article in Bloomberg News, a physician "voluntarily reported the case of a so-called externalized wire from April 17 to the Food and Drug Administration, according to a posting on the agency's Maude safety database." The physician did not notify "St. Jude, according to the FDA's posting."

To date, no regulatory action has been taken in light of this reported adverse event. But it is certainly an indication that the insulation issue of the Riata leads has yet to be resolved. Patients and physicians should closely monitor developments related to the Durata system.