SynchroMed® II Implantable Drug Infusion Pump: Update to the April 2014 communication on overinfusion

Medtronic International Limited would like to update healthcare professionals on the issue of overinfusion associated with the Medtronic SynchroMed® II Implantable Drug Infusion Pump, which was communicated in April 2014. Medtronic’s investigation has identified risk factors that may increase the likelihood of overinfusion. This include clinical use conditions such as the use of non-indicated drug formulations, overfilling of the pump reservoir, operation of the pump with no fluid in the reservoir, catheter occlusion, and pump stops or motor stalls lasting more than 48 hours. Overinfusion may result in life-threatening events due to drug overdose, and may also result in drug withdrawal syndromes due to emptying of the pump prior to a planned refill. Healthcare professionals are advised to use indicated drug formulations for the SynchroMed® II Implantable Drug Infusion Pump to minimise the risk of overinfusion. Healthcare professionals are also advised to perform verification checks on their implanted patients at each refill visit; to always follow pump refill instructions; and to educate patients and caregivers on the signs and symptoms of drug overdose, underdose and withdrawal. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.