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.

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

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.