Today we were made aware of an email blast from the American Epilepsy Association regarding a Safety Notice for the LivaNova SENTIVA VNS Therapy device, model 1000.
This message has created a lot of concern within the Canadian epilepsy medical community. We understand the concern regarding this notification from the American Epilepsy Society on the subject of the Therapy devices.
This issue first came to light in August 2019 in the USA. A select number of devices were identified as potentially at risk. All unimplanted devices were removed from circulation, and American centres were alerted to this information.
This safety notification occurred prior to the Health Canada approval of SENTIVA. As such, all products available to Canadian patients are NOT affected by this notification. This safety notice does not apply to those patients implanted in Canada.
We are sorry for the obvious concern and anxiety that such information has caused in the medical community and patients/families alike, but please rest assured that it does not apply in Canada. If ever LivaNova Canada was to be advised of a product action that affected Canadian patients, it would be our highest priority to notify all appropriate Canadian medical personnel in an expeditious manner. No one would first learn of it through third party sources.
Again we are sorry for the concern that has been caused by this message from the American Epilepsy Society.
Might I suggest that a notice be placed on the appropriate websites in an attempt to reassure Canadian patients that there is no need for concern.
- LivaNova Representative
Should you have any further concerns on this matter, we recommend contacting LivaNova Canada at:
1.800.268.6552 (ON/QB only)
Revised: December 20th, 2019