Vercise Genus™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) – effects associated with device resets

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals of the potential for Vercise Genus™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) stimulation therapy to be transiently suspended during charging due to a device reset, which occurs in response to potential interference. The frequency of occurrence of this reset behaviour is random and remote, and patients may not report any discernible impact. An IPG firmware update is available for patients who have experienced undesired effects due to the device reset behaviour.

Healthcare professionals are advised to:
(1) Review any patient reports of undesired sensations indicative of potential device reset behaviour during IPG charging and report these observations accordingly to Boston Scientific.

(2) After Boston Scientific verifies this device reset behaviour has occurred during IPG charging, an in-field IPG firmware update can be scheduled for the patient’s device to eliminate the possibility of a system reset.

Please refer to the letter for details.

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

29 Apr 2024

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.