Labelling Update of Medtronic Spinal Cord Stimulation (SCS) Therapy to include the Potential for Epidural Mass Causing Spinal Cord Compression

Medtronic International Limited (Medtronic) would like to inform healthcare professionals of an upcoming labelling update for Medtronic Spinal Cord Stimulation (SCS) Therapy. Medtronic is issuing this letter as there have been reports received describing delayed spinal cord compression due to an epidural mass around a Medtronic SCS lead. The data indicates that this issue is not limited to specific lead models or lead location. The current labelling for Medtronic SCS Therapy will be updated to address the potential for epidural mass formation and subsequent spinal cord compression. Healthcare professionals are advised to refer to the letter for more 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.