The Texas medical device manufacturer Cyberonics has recalled its Model 106 AspireSR VNS Therapy generators over concerns about a risk of device failure. According to a warning letter issued by the company, software problems on the Cyberonics Model 106 generators may cause them to stop working, putting patients at risk of complications.
The Model 106 generator is a component of the Cyberonics Aspire Seizure Response vagus nerve stimulation system. AspireSR VNS Therapy has been approved by the FDA to treat patients with partial onset seizures and depression.
When patients are prescribed the VNS Therapy Systems, a generator (such as the Model 106) is implanted in the patient’s chest just below the skin. A lead wire attached to the generator is coiled around the patient’s vagus nerve, allowing the system to deliver electrical stimulation.
According to the “Dear Doctor” letter issued by Cyberonics about the recall, VNS Therapy Systems equipped with a Model 106 generator may experience software problems that can cause the device to stop functioning properly. Cyberonics stated that when the AutoStim Output Current on the M106 generator is set at greater than or equal to the Magnet Output Current on the device, the generator may stop delivering stimulation.
Cyberonics recalled the Model 106 generators after the company received multiple reports of problems with the devices that could cause them to become disabled while they are in use. Warnings issued by Cyberonics and the FDA state that devices affected by this problem will display an error message stating that they have suffered a “Burst Watchdog Timeout” if the error occurs.
Although Cyberonics writes that patients can have this issue fixed at their next doctor’s appointment, patients who experience problems with their Model 106 generator may suffer complications before they are able to visit a doctor. In particular, patient may experience a recurrence of the seizure or depression symptoms that the VNS Therapy System is designed to treat.
The recall by Cyberonics of its VNS Therapy AspireSR Generator Model 106 is one of six times the device has been recalled by the company. In October and November 2015, the Model 106 generators were recalled because of a problem with the ‘Verify Heartbeat Detection’ feature that could decrease its battery life. In June 2017, Cyberonics recalled the M106 generators because of a manufacturing defect that could lower the longevity of the device. In November 2017, Cyberonics recalled Model 3000 VNS Therapy Programmer, including models equipped with the Model 106 generator due to a variety of problems that could lead to device failure or other complications. In January 2018, VNS Therapy Systems with the Model 106 generator were recalled because of a display warning issue.
Lawsuits Involving Medical Device Defects Filed by Heygood, Orr & Pearson
Regulatory agencies like the FDA monitor the safety medical devices to make sure that these product comply with federal safety regulations. Yet in spite of these efforts, thousands of patients in the U.S. are injured every year as a result complications from defective, dangerous, or improperly manufactured medical products.
If you or a loved one have suffered complications from a Cyberonics VNS Therapy System equipped with a Model 106 AspireSR generator, you may qualify to take legal action. The first step in finding out if you are eligible to file a lawsuit is to speak with an attorney who has the experience in medical device litigation to guide you through the process of filing a case.
For a free legal consultation and to find out more about taking legal action, 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 Cyberonics case evaluation form and answering a few short questions to get started.
Case results depend upon a variety of factors unique to each case. Results of other cases do not guarantee or predict a similar result in any future case.