Two Riata Lead medical devices, recalled in 2011, still remain in thousands of patients nationwide. Product recall attorneys warn those patients that the Riata products can cause serious injury, cardiac arrest, and death.
In late 2011, the FDA issued a Class I recall for the St. Jude Riata and Riata ST Silicone Endocardial Defibrillator Leads. The Class I recall is the most severe FDA designation, reserved for drugs and products that can cause serious injury or death. Today, there are still nearly 80,000 patients with the devices still active inside of them. One of these patients is a nine-year-old girl from Illinois, who suffers from a rare heart condition called Long QT Syndrome.
The girl’s parents learned of the recall just recently and completely by accident. Her mother saw mention of the recall in an e-mailed newsletter, and quickly connected the dots. She was surprised, troubled, and angry that no one notified her of the recall, which took place in 2011. In searching for answers, the manufacturer, St. Jude Medical, told her that the FDA or her daughter’s physician should have told her. The FDA said that responsibility was St. Jude’s. In a statement, the FDA maintained that, when a product is recalled, the manufacturer must notify the FDA, healthcare professionals, and patients who may be affected by the recall.
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NBC Chicago investigated the issue. In another statement, St. Jude Medical stated they provide detailed information to health care providers, who are expected to relay that information to patients. When asked, Advocate Children’s Hospital said that individual circumstances dictate how and when patients are contacted about recalls, and that they are currently investigating this particular incident.
If a defibrillator malfunctions, several serious outcomes may occur, all of which result in emergency medical attention. Because the defibrillator lead is responsible for shocking the heart back into rhythm, if the lead wires malfunction, the risk of cardiac arrest is increased. A defibrillator lead wire can detach or break from the device, and is then unable to sense irregular heartbeats and cannot provide the electric shock therapy to keep a patient alive. Troublingly, these leads never undergo any human testing before they are released for patient use.
It is also possible for the wire to detach or break and pierce the heart wall, causing perforation. In one case, Pace Medical Journal reported that the wire was nearly penetrating through the skin of a patient. Perforation of the heart is a very severe circumstance, which is why individuals who have received a St. Jude Medical Riata Defibrillator should seek consultation from both a medical professional and an experienced attorney, who can retrieve damages from medical bills and suffering.
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The Illinois girl suffered from a similar defect in 2009, when a recalled Medtronic device malfunctioned. One day, the girl’s defibrillator began firing relentlessly, sending electrical shocks throughout her body at a rate of nearly 20 times an hour. The Medtronic device was associated with more than 2,000 injuries and 13 deaths that year, so her family switched her defibrillator to the St. Jude Medical product.
In 2012, the FDA released a Safety Communication, in which it advised all Riata patients to undergo a fluoroscopy or two-view x-rays to establish whether or not the device was causing serious injury or defections. Earlier that year, a New York Times article reported on research that found at least 20 deaths associated with Riata defibrillators.
Too many patients are now faced with an unfair choice: leave the defective device in, or undergo a complicated surgery to remove it, and replace it with another device that may cause the same complications. Product manufacturers need to be subject to stricter guidelines, to protect American patients who are already suffering from serious conditions like Long QT Syndrome.