Risk of Premature End of Service with specific lots of Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ Generators

A Dear Healthcare Professional Letter has been issued by LivaNova Singapore Pte. Ltd. to inform healthcare professionals that specific lots of the LivaNova Vagus Nerve Therapy™ Systems (Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ Generators) may stop delivering therapy due to premature battery depletion caused by the microcontroller (an internal component). The loss of therapy may cause patients to experience a change in clinical symptoms e.g. increase in seizures, and may require generator replacement surgery to resume therapy. Healthcare professionals are advised to monitor patients for changes in clinical symptoms or loss of perception of stimulation, perform system diagnostic testing at each patient office visit to monitor generator battery status and follow the recommended actions to counsel patients who have been implanted with the affected devices. Please refer to the letter for details.

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

7 Feb 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.