Cyberonics has recalled AspireSR Model 106 Generators used in the company’s VNS Therapy System on six occasions due to problems that could lead to serious complications. Patients who were implanted with a Cyberonics VNS Therapy System equipped with the Model 106 Generator may be eligible to file a lawsuit over complications involving their epilepsy or depression symptoms that were made worse due to defects with this device.
In December 2015, Cyberonics (now owned by LivaNova) recalled the Model 106 Generator because of a software defect that could cause the device to stop working. According to the company, these generators may suffer a software error known as a “Burst Watchdog Timeout.” When this error occurs, the Model 106 Generator may stop delivering electrical stimulation to the patient’s vagus nerve. In other cases, the generator may continue delivering stimulation that is not felt by the patient. The only way for patients who stop sensing electrical stimulation from their VNS Therapy System to know if the device is still working is to visit their doctor to have it inspected and, if necessary, have their doctor fix the settings that are causing the error to occur.
In addition to the December 2015 recall of the Model 106 Generator, Cyberonics has issued five more recalls involving this device. Earlier in 2015, the company recalled the generator twice because of battery problems with the device. In 2017, the Model 106 Generators were recalled due to manufacturing defects that could reduce its longevity. Later that year, Cyberonics recalled VNS Therapy Systems equipped with the Model 106 Generator because of several problems that could cause the device to stop working. In 2018, the company recalled the generators because of a warning error.
Patients who were implanted with a VNS Therapy System equipped with the Model 106 Generator may be at risk of complications if one of these defects causes the device to stop working. If problems with the Model 106 Generator cause the VNS Therapy System to stop delivering stimulation to the vagus nerve, the epileptic seizures or depression symptoms that the device was designed to treat could reoccur or become worse, putting patients at risk of serious complications.
Complications from a Cyberonics VNS Therapy System? Our lawyers can help.
If you or a loved one suffered complications involving a Cyberonics VNS Therapy System with an AspireSR Model 106 Generator, you may be eligible to file a lawsuit. The first step in taking legal action is to consult with an attorney who has the experience in medical device litigation to guide you through the steps in filing a claim.
The lawyers at Heygood, Orr & Pearson have filed lawsuits on behalf of patients who have suffered serious or even fatal complications from defective medical devices. Our firm has also represented patients who were injured by dangerous drugs and other commercial products.
Medical device manufacturers and other companies who sell health products have a responsibility to make sure that their products are safe, effective, and fully compliant with federal health regulations. When medical devices, drugs, or other products cause injuries or deaths in patients who use them, our law firm believes the companies who made them should be held accountable for their negligence in a court of law.
For more information about filing a lawsuit against Cyberonics over complications from a defective Model 106 Generator, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form to receive a free legal consultation about your case.