Contraindications

The VNS Therapy System cannot be used in patients after a bilateral or left cervical vagotomy. Do not use short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy on patients implanted with the VNS Therapy System. Diagnostic ultrasound is not included in this contraindication.

Warnings

Neurologists should inform patients about all potential risks and adverse events discussed in the VNS Therapy System Physician’s Manual including information that VNS Therapy may not be a cure for epilepsy. Since seizures may occur unexpectedly, patients should consult with a neurologist before engaging in unsupervised activities, such as driving, swimming and bathing, or in strenuous sports that could harm them or others.

Patients who have pre-existing swallowing, cardiac or respiratory difficulties (including, but not limited to, obstructive sleep apnea and chronic pulmonary disease) should discuss with their Neurologist whether VNS Therapy is appropriate for them since there is a possibility that stimulation might worsen their condition.

The VNS Therapy System may affect other medical devices and other medical devices may affect the VNS Therapy System. MRI can be safely performed; however, special equipment must be used.  Refer to VNS Therapy System Physician’s Manual for details.

Adverse Events

The most common reported side effects from stimulation include hoarseness, paresthesia (prickling feeling in the skin), dyspnea (shortness of breath) and increased coughing. The most commonly reported side effect from implant surgery is infection.

The information contained in this website represents partial excerpts of important prescribing information taken from the product labelling. The information is not intended to serve as a substitute for a complete and thorough understanding of the VNS Therapy System nor does this information represent full disclosure of all pertinent information concerning the use of this product.
 

For more information on the VNS Therapy for pharmacoresistant epilepsy please contact us or visit the Cyberonics website.