Important information regarding handling of Medtronic DBS Pocket Adaptor Models 64001 and 64002 during implant procedure

Medtronic International Limited would like to remind healthcare professionals of the handling procedure for Deep Brain Stimulation (DBS) therapy pocket adaptors models 64001 and 64002 as stated in the current labelling in the implant manual following recent reports of high impedances from returned product analysis. Subsequent analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block. In the event when there is high impedance, there may be no or intermittent stimulation from the DBS device. Healthcare professionals are advised to follow instructions defined in the implant manuals on adaptor handling to minimize the potential for conductor wire fracture, and to complete a system integrity check for proper electrode impedances prior to pocket closure. Please refer to 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.