In 2015, Cyberonics recalled its Model 106 AspireSR VNS Therapy generators due to a risk of potential problems with this device. According to a warning published by the FDA, patients implanted with a Cyberonics VNS Therapy System that is equipped with a Model 106 AspireSR generator may experience problems that could cause the device to stop delivering stimulation to the vagus nerve.
According to Cyberonics, some patients who experience problems with Model 106 generators may need to visit their doctor to have the problem fixed; until they do, the VNS System may be effective at treating their epilepsy or depression symptoms. Some patients may also be forced to undergo surgery in order to have the device removed due to an ongoing risk of complications.
What is the Cyberonics VNS Therapy System?
The Cyberonics Vagus Nerve Stimulator (VNS) Therapy System was approved by the Food and Drug Administration in 1997. The device is intended to treat patients who suffer from partial onset seizures that have not responded to therapy with anti-epilepsy medications.
In 2005, Cyberonics received approval from the FDA to distribute VNS Therapy Systems for the treatment of patients with depression.
Patients who are to be treated with a Cyberonics VNS Therapy System are implanted with a generator below the skin in the upper chest area. This generator is connected to lead wires, which travel from the chest to the throat area and are wrapped around the vagus nerve. Electrical signals can then travel from the generator to the vagus nerve via these leads to deliver stimulation.
Problems With Model 106 AspireSR VNS Therapy generators
The Cyberonics Model 106 AspireSR (Seizure Response) is one type of generator used with the VNS Therapy System. The Model 106 AspireSR VNS Therapy generator features an Automatic Stimulation Mode designed to help patients who experience seizures associated with a type of cardiac rhythm increase known as ictal tachycardia.
In 2015, Cyberonics issued a “Dear Doctor” letter after discovering problems with the Model 106 AspireSR VNS Therapy generator. According to the letter and a recall notice issued by the FDA, problems with the software used in the Model 106 AspireSR generator could cause the device to stop delivering stimulation, making the VNS system ineffective at treating patient with epilepsy or depression.
Cyberonics stated in the letter that problems with the Model 106 generator can occur due to a number of circumstances. When the “AutoStim Output Current is programmed greater than or equal to the Magnet Output Current” on the generator, it can cause the generator to stop delivering stimulation.
Patients who are unable to feel any stimulation from their VNS Therapy System should contact their doctor immediately to have them check for problems with the Model 106 AspireSR generator. If problems with the Model 106 generator have caused the VNS Therapy System to stop delivering stimulation, a doctor can adjust the device’s settings to fix the problem and prevent it from recurring in the future.
Other Potential Complications with Model 106 AspireSR generators
Cyberonics has warned about other potential complications associated with its Model 106 AspireSR VNS Therapy generators.
The Model 106 generator is designed to automatically detect heart rhythm changes in patients who are implanted with the device. Because of this, placement of the generator is crucial to it to be able to properly detect heart rhythm changes. If the Model 106 generator is improperly placed during surgery, it may cause the VNS Therapy System to fail to function properly.
Because the Model 106 generator is designed to detect changes in heart rate, changes that are unrelated to seizure activity may also cause the device to register a false positive. This can cause the generator to deliver unintended electrical stimulation to the vagus nerve.
Problems with a Cyberonics generator? Our lawyers can help.
If you or a loved one have suffered problems a Cyberonics Model 106 AspireSR VNS Therapy generator – including complications that required the removal of the device – you may qualify to file a lawsuit. The first step in taking legal action is to speak with an attorney with the experience in medical device litigation to ensure that your rights are protected.
At Heygood, Orr & Pearson, we believe that when medical device manufacturers fail to properly ensure that their products meet minimum health and safety standards, they should be held accountable for the injuries and complications caused by their products. The lawyers at our firm have resolved hundreds of legal claims involving defective medical devices, dangerous drugs, or other health care products on behalf of our clients.
For more information about filing a lawsuit against Cyberonics regarding problems with the company’s Model 106 AspireSR VNS Therapy generators, 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 case evaluation form and answering a few brief questions about your case to get started.