Use of MRI mode on Proclaim™ XR SCS System, Proclaim™ Elite SCS System (Model Numbers 3660, 3662) and Infinity™ DBS Systems (Model Numbers 6660, 6662)

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) to inform healthcare professionals on the use of the magnetic resonance imaging (MRI) mode feature on the Proclaim™ XR SCS System, Proclaim™ Elite SCS System and Infinity™ DBS System and associated risks related to the inability to exit from the MRI mode, including the potential need for implantable pulse generator (IPG) surgery to restore therapy. Abbott has received complaints from patients who are unable to exit from the MRI mode, as their Patient Controller has lost the ability to connect or communicate with their IPG while in MRI mode. This has occurred in situations where the user deleted the Bluetooth® pairing, lost or disabled their Patient Controller, or upgraded the iOS software on their Patient Controller while in MRI mode. The overall worldwide occurrence rate of this issue is 0.06% with 0.03% resulting in loss of therapy and additional surgery to restore therapy. Healthcare professionals are advised to remind patients to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode, and review Abbott’s advisory to reduce the risk of loss of therapy and the need for IPG replacement surgery to restore therapy. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

3 Aug 2023

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.