There is growing research linking the St. Jude Durata defibrillator lead to abrasion and failure. A recent study of the FDA adverse-event database has found the Durata associated with dozens of events, including one patient’s death. Although St. Jude defends the safety of the Durata, the FDA has recently asked the company to conduct a three-year safety study to better understand the risks and safety of this device.
What is the St. Jude Durata Defibrillator Lead?
The Durata is a defibrillator lead manufactured by St. Jude Medical, a Minnesota-based medical device company. The Durata is St. Jude’s newer generation of defibrillator leads, introduced after the company recalled the Riata leads. The newer leads are coated with a material St. Jude calls Optim, which the company claims is safer and more durable than the defective coating on the Riata defibrillator leads.
The FDA approved Optim in 2006 as a pre-market approval supplement for use in Riata ST Optim. The FDA approved Optim-covered Durata leads in 2007.
The lead is a wire that connects a defibrillator to heart tissue. The defibrillator itself is located outside the heart, and it is responsible for monitoring heart rhythm and delivering a high-voltage shock during serious arrhythmias. The lead is a long, thin wire that is connected directly to the heart tissue. The lead is responsible for transmitting data from the heart to the defibrillator, and also carrying the high-voltage shock.
Problems with the St. Jude Durata
There is growing concern that the St. Jude Durata may have a similar defect as the Riata defibrillator leads. St. Jude stopped selling the Riata in 2010, and recalled the product in November 2011, after receiving reports of premature failure. The Riata was susceptible to inside-out erosion, in which the inner conductor wires eroded against the external insulation, until the conductor was eventually externalized.
Although there are only a few reports of inside-out abrasion associated with the Durata, there are dozens of reports of outside-in abrasion. This occurs when the defibrillator lead rubs against other devices inside the body.
Damaged defibrillator leads can malfunction. They may deliver an unnecessary shock, or fail to shock when the patient has an arrhythmia. Unfortunately, defective defibrillator leads are very problematic. It is difficult to tell whether a damaged lead is actually defective until a serious adverse event occurs. Prophylactic surgery to remove the lead is not recommended, because surgery itself has a very high risk of injury or death.
Study Links St. Jude Durata to Injuries, Death
Dr. Robert G. Hauser, a prominent cardiologist at the Minneapolis Heart Institute, published a paper in August 2012 in Heart Rhythm Journal that found 52 instances where defibrillator leads with the Optim coating abraded. The Durata lead was responsible for 37 cases, of which:
- 32% had can abrasion (caused by contact between the lead and the pulse generator)
- 6% had abrasions caused by friction with another device, including a tricuspid valve annuloplasty ring
- 72% had electrical abnormalities
- Three malfunctioning leads had abrasions that could have been caused by friction, but the cause was not listed
- Three inside-out abrasions were identified — this type of abrasion is the same defect identified with the recalled Riata defibrillator leads
According to Dr. Hauser, “The results of this study suggest that Optim … does not prevent critical insulation failures in Riata ST Optim and Durata leads that are caused by friction with the can or another device. Of equal concern is the fact that these failures occurred in leads that had only been implanted for ~4 years or less.”
Dr. Hauser recommended that cardiologists should stop implanting the Durata defibrillator leads until more studies are conducted. In August 2012, shortly before Dr. Hauser published this study, the FDA asked St. Jude to conduct a three-year post-marketing surveillance study to better understand the risks of the Durata defibrillator lead.