Impact of Cycling Feature on Longevity and Recharge Interval of Activa®, Restore®, PrimaADVANCED® and Itrel® 4 neurostimulation devices

Medtronic International Limited (Medtronic) would like to inform healthcare professionals of corrections to labelling related to the cycling feature in some neurostimulation devices used for deep brain stimulation and spinal cord stimulation [Activa® PC, Activa® RC, Activa® SC, all Restore® devices (including SureScan®), PrimeADVANCED®, PrimeADVANCED® SureScan® MRI and Itrel® 4 devices]. This label change is required as the current labelling provides calculations which may not accurately account for the impact of cycling on device longevity or recharge interval under all programming scenarios. Elective Replacement Indicator (ERI) and End of Service (EOS) notifications will still occur accurately, as designed, upon interrogation by the patient programmer, recharger and/or N'Vision Clinician Programmer. Healthcare professionals are advised to 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.