Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning Medtronic Inc. SynchroMed II pump [Model 8637] [HKMD No.: 090082].
The manufacturer has 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 labeling. In this case, drug delivery will only resume after performing a post-MRI pump interrogation with the Clinician Programmer which will end telemetry mode.
According to the manufacturer, 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, and in severe cases (i.e., baclofen withdrawal), life-threatening or fatal withdrawal symptoms could occur.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Nov 2023