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Health Sciences Authority
Dear Healthcare Professional Letters

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)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 July 2023

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.

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 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.

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