August 17, 2012 — The U.S. Food and Drug Administration (FDA) is recommending that patients who have the St. Jude Riata defibrillator lead should undergo routine chest X-days or fluoroscopy. The FDA is warning that “These leads have an increased risk of premature insulation failure that can impact the lead’s ability to function properly.”
Although the defibrillator leads are supposed to last at least 10 years, the FDA has seen increased rate of failure only four years after the device is implanted. The externalized electrical wires do not always malfunction, but if they do, they could deliver inappropriate shocks or no shocks, which could be life-threatening or deadly.
In a Safety Communication, the FDA said, “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.”
According to the FDA, physicians are directed to notify their patients if they have one of the defective leads. Patients who have a defibrillator lead should also check with their physician to find out whether they have the lead. Patients with the lead should schedule a check-up with an X-ray, and they may need tests to check for electrical abnormalities with the leads.
Imaging tests may include a chest X-ray or fluoroscopy, which is a type of continual X-ray similar to a movie. A radiologist should help the physician evaluate the X-ray, because externalized cables can be very difficult to detect. The physician may also recommend voltage tests to check the electrical function of the lead.
If an X-ray finds signs of externalization, the FDA is not recommending routine removal of the lead. Removal should only be considered if electrical tests are also abnormal. Physicians and their patients should consider the risk-benefit of continued monitoring, or surgical removal of the lead, or capping it and leaving it implanted. Surgical removal is a serious ordeal that carries a significant risk if injury and death.
If you were injured by the St. Jude Riata or other St. Jude defibrillator lead, you are not alone. It is estimated that there are about 80,000 people in the United States implanted with this device, and 230,000 worldwide. A recent study found that 24% of large-diameter Riata leads have externalized wires, and 9% of small-diameter leads. It is possible that there are thousands of people who are implanted with a potentially harmful device.