Update on use of MRI mode on Proclaim™ XR SCS System, Proclaim™ Elite SCS System and Infinity™ DBS System

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) as a follow-up to their earlier communication in July 2023 to provide further details to 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. Between August 2015 and August 2023, there have been 131 SCS/DRG occurrences worldwide for permanent loss of therapy and 75 of those have resulted in IPG replacement surgery to restore therapy and 2 DBS occurrences of permanent loss of therapy, both of which resulted in IPG replacement surgery to restore therapy.  Loss of therapy may require acute medical intervention such as additional monitoring, medication and/or intervention to compensate for the loss of therapy and/or to prevent deterioration in a patient’s condition, with special consideration for DBS (Dystonia or Parkinson’s) patients. If the IPG is unable to exit from the MRI mode and additional troubleshooting steps are unsuccessful, an additional surgery would be required to replace the IPG 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 to follow the guidance currently available in the Instructions for Use and this communication for patients who need to receive an MRI scan. Please refer to the letter for details. Published: 20 Dec 2023

Dear Healthcare Professional Letters