The Food and Drug Administration approved Cyberonics’ AspireSR Model 106 Generators in 1997 for the treatment of patients with epileptic seizures. In 2005, the FDA also approved the Model 106 Generators for patients with depression that cannot be treated with medication.
The Model 106 Generator is a component in the Cyberonics VNS Therapy System. This device consists of a generator (such as the Model 106) attached to a lead wire coiled around the vagus nerve. The generator sends electrical stimulation to the vagus nerve through the lead wire, which can help to treat patients who suffer from seizures or depression.
In the years since the device was approved by the FDA, Cyberonics has recalled the Model 106 generator six times. These recalls have involved software problems, performance issues, and other defects that could cause complications in patients who are treated with these devices.
In December 2015, Cyberonics recalled the Model 106 Generators after uncovering software problems that could cause the device to stop delivering electronic stimulation to patients. According to a warning issued by the FDA, when the settings on the generator are configured incorrectly, it could cause a software malfunction known as a “Burst Watchdog Timeout.”
When this error occurs, the device may fail to deliver stimulation or may continue delivering stimulation that is undetectable by the patient. Unless the software error is corrected by a doctor, patients could be at risk of complications from the recurrence of their seizures or depression symptoms.
Cyberonics has recalled devices equipped with the Model 106 generators on five additional occasions. In October and November 2015, the company pulled these devices due to problems with their “Verify Heartbeat Detection” feature, which could reduce their battery life. Cyberonics recalled the Model 106 Generators in June 2015 because of a manufacturing defect that could reduce the device’s longevity. In November 2017, Cyberonics recalled devices equipped with the generator due to a number of problems that could lead to the failure of the device. Finally, in January 2018, Cyberonics recalled Model 106-equipped devices due to an incorrect warning message.
Cyberonics Claims Handled by Heygood, Orr & Pearson
If you or a loved one were treated with a Cyberonics VNS Therapy System equipped 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 experienced attorney who can advise you regarding your legal rights and guide you through the first steps in filing a claim.
The lawyers at Heygood, Orr & Pearson have filed lawsuits on behalf of individuals who suffered serious or fatal complications from defective medical devices, dangerous drugs, and other medical products. Medical device manufacturers and other companies who make medical products have a duty to ensure that these products are safe and effective. When these devices cause serious injuries or deaths to the patients who use them, we believe their manufactures should be held accountable for their negligence in a court of law.
For more information about filing a lawsuit against Cyberonics and to learn more about whether you may be eligible to file a claim, contact the lawyers at Heygood, Orr & Pearson for a free legal consultation. You can reach us by calling toll-free at 1-877-446-9001, or by following this link to our free Cyberonics case evaluation form and answering a few brief question to get started.