Doctor Says St. Jude Durata Lead Wires May Have Abrasion ProblemsAug 23, 2012 | Parker Waichman LLP
A leading cardiologist is again sounding an alarm over the safety of a new implanted cardiac defibrillator (ICD) lead manufactured by St. Jude Medical Inc.
According to a Minneapolis Star-Tribune report, Dr. Robert Hauser believes there is not enough evidence to guarantee the safety of the new Optim coating that’s placed on the conductive ends of the new and allegedly improved Durata ICD lead. The Durata, like other leads, are the wires connecting from an ICD to a patient’s heart. They’re implanted in the heart and routinely deliver necessary shocks to a heart to keep it beating or to regulate its rhythm.
St. Jude Medical recently recalled its Riata and Riata ST line of ICD leads because they were prone to break free of its insulated coating. This defect exposes the conductive end of the heart, putting patients at risk of dangerous complications, including a failure to deliver the necessary shocks. The Riata leads were also prone to cause internal injuries, including lacerations to the heart and areas surrounding the heart.
After the recall of the Riata leads, St. Jude attempted to defend itself against claims that the devices were responsible for at least 20 deaths. Those charges were leveled against the devices by Hauser, a cardiologist at Minneapolis Heart Institute, who investigates device failures independently of his job. In a study, he blamed the Riata leads for nearly two dozen deaths. The company initially fought against those claims, still while admitting its defects.
In replace of Riata, the company launched the Durata leads featuring the Optim coating. The coating was supposed to be an improvement and not prone to allowing the conductive end of an ICD to break through it. Hauser believes the initial belief that it’s safer because it’s newer is short-sighted, at least for now. St. Jude promotes the Optim coating as being “50 times more abrasion-resistant than silicone leads.”
Hauser’s initial research found that the new Optim coating is not prone to the “inside-out” abrasion that ultimately led to the recall of the Riata leads but was not exactly wear-resistant, as St. Jude claims. The cardiologist says he has reports of several high-voltage failures linked to the Durata leads with the Optim coating. He also is aware of at least one death caused by this defect.
The research he conducted included a search of the Food and Drug Administration’s Manufacturers and User Device Experience (MAUDE) database looking for reports of lead abrasion. In all, he found 15 involving the Riata leads with an Optim coating and another 37 with the coating on the Durata leads. The Star-Tribune reports, “eight of the 15 Riata ST Optim leads had ‘can’ abrasions from rubbing against the defibrillator itself and three abrasions were most likely caused by friction with another lead.” The Durata had a dozen reports of the same abrasions and six caused by friction with another device. Thirteen of those failures had “electrical abnormalities,” the report continued.