August 17, 2012 — The U.S. Food and Drug Administration (FDA) is recommending chest X-rays for patients who have the St. Jude Riata or Riata ST defibrillator leads. The FDA is concerned because, “These leads have an increased risk of premature insulation failure that can impact the lead’s ability to function properly.” Instead of lasting for ten years or more, the FDA has seen an increased rate of failure after just four years. If a defibrillator lead malfunctions, it could cause abnormal sensing, delivery of an inappropriate shock or no shock therapy, which could be life-threatening or deadly.
According to the FDA, “We believe that assessing the current condition of Riata and Riata ST leads is likely to help health care providers develop individualized plans for their patients, which may include recommendations on the frequency of remote monitoring and the necessity and frequency of repeat imaging.”
The FDA is asking physicians to notify patients who have the Riata leads of the new recommendations. They are also recommending patients to ask their doctors whether they are affected by the new recommendations. If the patient has not had a recent evaluation, they should have tests to check for electrical abnormalities.
Assessing the defibrillator lead may include a chest X-ray or fluoroscopy (a type of continual X-ray, much like a movie). The FDA is recommending that physicians work closely with radiologists to examine the imaging tests, because externalized wires can be very difficult to see. Voltage-tests may also be beneficial for determining whether the lead is functioning.
The FDA is not recommending routine removal of any of the leads. However, if the lead has abnormal imaging and abnormal electrical function, physicians might consider the risks and benefits of extracting the old lead, or capping it and leaving it in place. Surgery to remove a defective lead has a significant risk of injury and death, which is why it is not usually recommended.
If you were injured by the St. Jude defibrillator lead, you are not alone. A recent study conducted by St. Jude found that 24% of large-diameter Riata defibrillator leads were externalized, and 9% of small-diameter leads were externalized. St. Jude stopped selling the Riata defibrillator leads in 2010, and they were officially recalled on November 28, 2011. About 80,000 leads have been implanted, and there are nearly 230,000 were distributed worldwide. This means that there are potentially thousands of people who have a defective defibrillator lead.