Cessation of therapy due to component issue with specific LivaNova Vagus Nerve Therapy™ Systems

A Dear Healthcare Professional Letter has been issued by LivaNova Singapore Pte. Ltd. to inform healthcare professionals that the LivaNova Vagus Nerve Therapy™ Systems (Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ Generators) may cease to deliver therapy when the reed switch (an internal component) becomes stuck in a closed position. This loss of stimulation may cause patients to return to baseline seizure frequency or depressive symptoms, leading to generator replacement surgery. Healthcare professionals are advised to monitor the patient for changes in clinical symptoms or loss of perception of stimulation, and to refer to the letter for the list of affected devices in Singapore. The VNS Therapy Instructions for Use will be updated to reflect the relevant patient management recommendations. Please refer to the letter for details.

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

23 Jan 2025

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.