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Health Sciences Authority
Dear Healthcare Professional Letters

Restore Clinician Programmer Application software update Model A71100

Audiences

Healthcare professional

Industry member

Product type

Medical devices

6 August 2020

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

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform users about a software update to version 1.0.4255 for the A71100 Restore Clinician Programmer Application to correct the compatibility issue that the current version 1.0.4232 has with some legacy clinician programmer software. This issue manifests in the patient programmer as an inability to establish communication with the implanted device. As a result, the patient is unable to use the patient programmer to turn stimulation on/off, to switch between programs, to increase/decrease output or to otherwise manage their therapy. However, the therapy continues to be delivered per the programming that was saved at the most recent clinician programming session. Medtronic Neuromodulation has assessed the product events related to the issue and determined this to result in a low risk to the patient; 75% of impacted patients reported no return of symptoms or loss of therapy while 25% of impacted patients reported non-optimal therapy that they were able to manage until returning to the clinic. Healthcare professionals may contact their Medtronic representative to arrange for a software update visit or refer to the instructions appended in the letter to update the software. 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.

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