On August 16, 2012, the U.S. Food and Drug Administration issued its formal recommendation that patients with implantable heart defibrillators that have the Riata and Riata ST leads manufactured by St. Jude Medical should have x-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the leads. The leads are the wires that are attached to the defibrillators that are inserted into the heart.
The leads connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart in order to monitor its rhythms. ICDs and CRT-Ds can detect life-threatening abnormal heart rhythms and deliver an electrical shock to the heart to restore normal heart rhythms. ICD and CRT-D leads typically have layers of insulation surrounding them that protect electrical conductor wires inside the lead.
St. Jude Medical stopped selling the Riata and Riata ST leads in late 2010 and recalled them in November 2011 following reports of insulation failure: the premature erosion of the electrical conductor wires. Insulation failure may cause some of the electrical conductors inside Riata leads to move within or move entirely outside the outer lead insulation. The lead may malfunction and lead to inappropriate or no shock therapy and potentially life-threatening abnormal heart rhythms. As of 2011, approximately 79,000 patients in the United States still have Riata leads implanted in them.
And in April 2012, St. Jude Medical voluntarily recalled and stopped selling its QuickSite LV CRT leads and QuickFlex LV CRT leads due to insulation abrasion.
The FDA’s recommendations are supported by several studies that have demonstrated that routine imaging of the leads may detect previously unrecognized abnormalities with the insulation. X-rays or other imaging techniques will help health care providers develop individualized patient treatment plans. The FDA also cautioned against routine removal of leads without careful evaluation of benefits and risks to the individual patient.
The FDA is also requiring St. Jude Medical to conduct three-year postmarket surveillance studies related to the potential for premature insulation failure in Riata and Riata ST leads that must address the number of patients with evidence of insulation failure and whether the failure was detectable with X-ray imaging; how soon after implantation the lead insulation fails; the time between lead implantation and lead malfunction; and, adverse events associated with treatment for failing or malfunctioning leads.
The FDA is further requiring St. Jude Medical to conduct post-market surveillance studies on its QuickFlex LV CRT leads; QuickSite LV CRT leads; and, Riata ST Optim and Durata ICD leads. (CRT devices are small, battery-powered units implanted in the chest of patients to treat heart failure by helping the left and right sides of the heart beat in unison. Like ICDs, CRTs use insulated leads to monitor the heart’s rhythm and to deliver electrical therapy to the heart.)
In discussing the FDA’s recent recommendations, the Director of the FDA’s Center for Devices and Radiological Health stated, “The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients. However, the agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the postmarket surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions.”
If you or a loved one have an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator and have experienced problems or issues with them or their leads, or you have suffered injuries as a result, you should promptly seek the advice of a local medical malpractice attorney to investigate your claim for you.
Click here to visit our website or telephone us toll-free at 800-295-3959 to be connected with medical malpractice lawyers in your state who may be willing to assist you with your possible claim.
Turn to us when you don’t know where to turn.