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. Published: 29 Dec 2023

Dear Healthcare Professional Letters