MRI Guidelines for the SynchroMed™ II Programmable Drug Infusion System

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals about the need to interrogate the SynchroMed™ II Programmable Drug Infusion System following Magnetic Resonance Imaging (MRI). It was recently identified that if the SynchroMed™ II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labelling. In this case, drug delivery will only resume after performing a post-MRI pump interrogation with the Clinician Programmer which will end telemetry mode. If the SynchroMed™ II pump does not resume drug delivery after leaving the MRI magnetic field, patients may experience a return of underlying symptoms (i.e. pain or spasticity) due to loss of therapy, potentially requiring outpatient or inpatient management. In severe cases (i.e. baclofen withdrawal), life-threatening or fatal withdrawal symptoms could occur. Healthcare professionals are advised to interrogate the pump with the Clinician Programmer to end telemetry mode and resume drug delivery upon completion of an MRI scan, and educate patients/caregivers to recognise the signs and symptoms of intrathecal drug therapy underdose or withdrawal. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

4 Jan 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.