Label updates on reported events related to Medtronic Deep Brain Stimulation tunneling procedure

Medtronic International Limited would like to notify healthcare professionals of the label updates for Medtronic Deep Brain Stimulation (DBS) Therapy, in particular with Tunneling tool Model 3755 and DBS Extensions Models 7483 and 37086 related to the tunneling procedure. Medtronic has identified serious events or injuries associated with tunnelling procedure that are not presented in the current labelling. These events, including cases of spinal accessory nerve injuries, occurred in an estimated 0.008% of tunneling procedures. Medtronic is working to update the labels of DBS with these events. Healthcare professionals are advised to practice caution while tunneling the extension from the lead to the implantable neurostimulator. 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.