Update on reduced battery performance of the model 8637 SynchroMed® II Implantable Drug Infusion Pump due to formation of resistive film within the battery

Medtronic International Ltd would like to update healthcare professionals on the failure rate of Medtronic Model 8637 SynchroMed®II pumps manufactured prior to August 2011 due to reduced battery performance and to reinforce the previously communicated patient management recommendations. For these affected pumps, a sudden loss of therapy due to reduced battery performance from the formation of a resistive film may result in Low Battery Reset (critical alarm), premature Elective Replacement Indicator (non-critical alarm), or premature End of Service (critical alarm). Healthcare professionals are advised against prophylactic replacement of SynchroMed® II pumps with the prior battery design due to estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery.  When the critical or non-critical alarms noted occur, Medtronic strongly recommends that replacement surgery be scheduled as soon as possible for these patients. Ongoing patient management recommendations include increasing the critical alarm frequency and informing patients and caregivers to be alert of pump alarms. 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.