The Food and Drug Administration is advising patients who have defibrillators with St. Jude Medical wires that have been determined defective to have an X-ray or other type of scan to test the wire’s insulation for potential problems. Defibrillators are medical devices implanted in the chest to correct dangerous and sometimes fatal heart rhythms. Patients with Riata or Riata ST leads, wires that attach a defibrillator to a patient’s heart, may be at greater risk for failure of the defective devices because the insulation of the leads have failed in some patients. St. Jude stopped selling the Riata wires in late 2010 because of the defective leads. The company recalled the devices in late 2011.
The insulation of the leads can wear away, increasing the chances that the device could malfunction by either delivering a shock when none is needed, or failing to shock the patient’s heart when it is not beating properly. Removing the wires can be dangerous and is not recommended for all patients. The FDA is encouraging patients to have the heart scans done and then to talk with their doctor about the risks and benefits of having the leads removed.
In addition to the Riata and the Riata ST leads, St. Jude also recalled its QuickSite and QuickFlex leads this year. The FDA had ordered St. Jude to conduct a three-year study to learn more about the risk of insulation failure.
Approximately 79,000 patients in the U.S. still have Riata wires connected to their defibrillator. Experts working on a way to manage patients with potentially defective Riata wires have expressed concern about lack of an ability to detect any defect until after something happens to a patient.
Research is still being conducted, but so far researchers believe the movement of the Riata wires within the insulated cord frays the coating enabling the wires to break free. Once the wire is exposed, it has the ability to flex causing additional damage that can worsen over time. The wires can be removed, but U.S. regulators warn patients that removing the Riata wires could pose an even higher risk to patients. At least two patients have died and others were seriously injured following the removal of the Riata.
The Philadelphia medical malpractice lawyers at Messa & Associates are experienced at handling medical malpractice cases resulting from medical errors or defective medical devices. Our extremely skilled team of medical malpractice lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered personal injuries as a result of a medical error, defective medical device, or any other type of negligent care received by a medical provider, contact the medical malpractice lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More