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Health Sciences Authority
Dear Healthcare Professional Letters

Loss of Stimulation and Over Stimulation – For Deep Brain and Spinal Cord Stimulation Therapies

Audiences

Healthcare professional

Product type

Medical devices

17 February 2014

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Medtronic International Limited (Medtronic) would like to inform healthcare professionals regarding two issues associated with the use of Medtronic neurostimulators: Loss of Stimulation and Over Stimulation. These issues are related to the 8870 N'Vision Application Card used in 8840 N'Vision Clinician Programmer that can be used to interrogate the implantable deep brain stimulator (DBS) and implantable spinal cord stimulator (SCS). The loss of stimulation, over stimulation or stimulation in the wrong area may occur to the Activa® PC, Activa® RC and Activa®SC implantable DBS, and RestoreUltra® and RestoreSensor® implantable SCS. Medtronic does not recommend prophylactic explant of the affected devices as these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an Implantable Neurostimulator Recharger using the Physician Recharge Mode. 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.

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