Synchromed II Infusion Pump: caution after MRI
Implant Hazard Alert: Medtronic Australasia Pty Ltd is alerting patients who have an implanted SynchroMed II Pump (model 8637) that it may not function properly after they undergo a Magnetic Resonance Imaging (MRI) procedure.
What is the problem?
When having an MRI scan, the SynchroMed II pump motor will temporarily stop the rotor of the device and drug infusion for the duration of the MRI exposure. The pump should resume normal operation once the MRI is complete.
If the SynchroMed II pump switches into telemetry mode (due to electromagnetic interference (EMI) from an MRI scan) while it is sounding an alarm, it will not resume the drug infusion once the scan is complete.
In this case, drug infusion will only resume after performing a post-MRI pump interrogation using the Clinician Programmer or Personal Therapy Manager.
What are the risks?
If the SynchroMed II pump does not resume drug infusion upon completion of the scan, patients may experience a return of their underlying symptoms (i.e., pain or spasticity) due to loss of therapy. In severe cases withdrawal symptoms could occur and may require outpatient, inpatient or emergency management.
What should patients do?
Upon completion of an MRI scan, you should interrogate the pump with the Personal Therapy Manager (myPTM programmer) to end telemetry mode and resume drug delivery. Instructions on how to confirm that the interrogation was successful are in the A820 myPTM App and Personal Therapy Manager Patient User Guide.
Alternatively, your clinician can interrogate the pump with the Clinician Programmer.
Before having an MRI, see the MRI Guidelines at www.manuals.medtronic.com.
What should health professionals do?
Health professionals should:
- ensure patients are aware of the problem, potential risks and how to recognise the signs and symptoms associated with intrathecal drug therapy underdose or withdrawal
- remind patients about the importance of interrogating the SynchroMed II pump after an MRI to ensure continuation of therapy, including the warnings provided in the Instructions for Use
- interrogate the pump with the Clinician Programmer to ensure it is working as required.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.