Labelling updates for Specify™ 5-6-5 Surgical Lead (model 39565-30, 39565-65) and Specify™ 2x8 Surgical Lead (model 39286-30, 39286-65)

Medtronic International Limited would like to notify healthcare professionals of a labelling update for Specify™ 5-6-5 Surgical Lead (model 39565-30, 39565-65) and Specify™ 2x8 Surgical Lead (model 39286-30, 39286-65). Medtronic is initiating this correction, as  their product labels do not distinguish between intraoperative stimulation testing with a permanent surgical lead and interoperative trial evaluation use. Healthcare professionals are advised to inform all staff that the leads are not intended for interoperative trial evaluation use. 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.