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Health Canada Medical devices

Synchromed II - Programmable Pump

Issued December 5, 2023
Issue
Medtronic 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. In this case, drug delivery will only resume after performing a post MRI pump interrogation with the clinician programmer which will end telemetry mode. Recall Start Date: November 21, 2023
Hazard description
Performance
Product
Product name
Synchromed II - Programmable Pump
Reference
ID
RA-74681