When people encounter serious heart problems to the point where they need to have devices implanted inside of them to help regulate their circulatory systems, the connections that are used to make sure that these devices are providing the proper energy and regulation are extremely intricate, delicate and sensitive. Patients literally trust their lives in many cases with the quality of the products that have been implanted, and if anything goes wrong those patients are placed in immediate and extreme danger. In short, these products need to work properly and dependably.
The wiring products that help to make the connections between heart-aiding devices and the human body are known as wire leads. One company that’s been dominating this market is known as St. Jude Medical, which released a product known as the Riata lead that was seen as one of the best in the world. Unfortunately, problems began to arise with this product and patients suffered immensely as a result. Below is a brief overview of what occurred and what you can do if you or someone you love has been harmed by this product.
Riata Leads FDA Warnings
After receiving a series of complaints from patients and others around the country, the Food and Drug Administration decided to investigate the Riata lead and St. Jude Medical to determine what could be going wrong. In the fall of 2012, the FDA conducted an on-site inspection of the company’s manufacturing plant in California. It found a total of 11 violations that it addressed in the form of a letter to the company. Generally, these problems dealt with potential design defects and deviations from what would be considered accepted practice in this manufacturing setting.
Over the next several months, St. Jude Medical reportedly responded to several of those concerns but it did not address all of them. As such, the FDA responded with yet another warning letter that promised additional actions if all of these concerns were not adequately addressed. To date, nothing else has developed and the company remains under scrutiny. It should be noted that St. Jude Medical has had at least one other wire lead product recalled because it was not functioning properly. Read more about the man who suffered a single shock and vibrations http://onlinelibrary.wiley.com/doi/10.1111/pace.12187/abstract
There are no real side effects that are related to malfunctioning wire leads. If they do not work properly, people’s hearts can fail and they can quickly lose their lives. It’s already bad enough to live with the stress of a bad heart but another thing entirely to wonder if every beat that’s felt was supposed to happen or if something was going wrong with the mechanical device that keeps them alive. People who are using this product may need to undergo a full medical evaluation to make sure that it’s working properly.
Questions & Answers About Riata Lead
What is the Riata Defibrillator Lead?
The Riata is a defibrillator lead, made by St. Jude Medical, a company from Minnesota. A lead is a wire which connects a defibrillator to heart tissue. The Defibrillator is located outside the heart, and monitors heart rhythm and delivers a high-voltage shock during serious arrhythmias.
What are the complications with using a Riata Lead?
The Riata Lead was introduced by St. Jude as a replacement for Ritata Lead, which was recalled in November 2011 after reports of premature failure. The Riata Lead was also susceptible to inside-out erosion, where the inner conductor wires erode against the external insulation.
For the Riata Lead, there were several reports of outside-in erosion, which occurs when the defibrillator lead rubs against other devices inside the body. The Riata Lead was made with a new type of coating called Optim, which was supposed to prevent fraying. However, in June 2012, it was discovered that a doctor had reported a Riata Lead fraying in a patient to the FDA.
According to a cardiologist at the Minneapolis Heart Institute, the Riata Lead was responsible for 37 cases of Optim coating abrasion, of which:
- 32% had can abrasion (contact between the lead and the pulse generator)
- 6% had abrasions cause by friction with another device
- 72% had electrical abnormalities
- 3 malfunctioning leads had abrasions that could have been caused by friction, but the cause was not listed
If you or someone you love trusted this product and you suffered as a result, you need to seek the help of Riata lead class action lawsuit lawyers who have been helping consumers hold corporations accountable all over the United States for decades. Contact National Injury Help today to schedule a free initial consultation.
Riata Leads Lawsuits in these States:
Alabama (AL), Alaska (AK), Arizona (AZ), Arkansas (AR), California (CA), Colorado (CO), Connecticut (CT), Delaware (DE), Florida (FL), Georgia (GA), Hawaii (HI), Idaho (ID), Illinois (IL), Indiana (IN), Iowa (IA), Kansas (KS), Kentucky (KY), Louisiana (LA), Maine (ME), Maryland (MD), Massachusetts (MA), Michigan (MI), Minnesota (MN), Mississippi (MS), Missouri (MO), Montana (MT), Nebraska (NE), Nevada (NV), New Hampshire (NH), New Jersey (NJ), New Mexico (NM), New York (NY), North Carolina (NC), North Dakota (ND), Ohio(OH), Oklahoma (OK), Oregon (OR), Pennsylvania (PA), Rhode Island (RI), South Carolina (SC), South Dakota (SD), Tennessee (TN), Texas (TX), Utah (UT), Vermont (VT), Virginia (VI), Washington (WA), Washington DC (DC), West Virginia (WV), Wisconsin (WI), Wyoming (WY)
St. Jude Riata Lead class action lawsuit page updated April 5, 2019