Proclaim™ XR 5 and Proclaim™ XR 7 Implantable Pulse Generators – Late battery elective replacement indicator notification

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) to inform healthcare professionals of a Medical Device Correction regarding the implantable pulse generator (IPG) battery elective replacement indicator (ERI) for patients with non-rechargeable Proclaim™ neurostimulation systems (Proclaim™ XR 5 and Proclaim™ XR 7 IPGs). The duration between the IPG reaching ERI threshold and end of service (EOS) may be 45-55% shorter than estimates provided in the clinician’s manual. This shorter duration is due to the IPG reaching ERI threshold later than expected. It does not involve premature IPG battery depletion and estimates of overall device longevity are not impacted. However, this could result in loss of therapy if the device reaches EOS prior to replacement surgery. Healthcare professionals are advised to refer to the recommendations in the letter on actions to be taken when an ERI notification appears and the recommended strategies for preventing lapse in therapy. 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.