Risk associated with insufficient recharging of the Medtronic RestoreSensor® Implantable Neurostimulators, Models 37714 and 97714

Medtronic International Ltd. would like to inform healthcare professionals of the risk of disruption in therapy with Medtronic RestoreSensor® Implantable Neurostimulators (Models 37714 and 97714). To date, Medtronic has received four instances of loss of therapy during recharging of the device, at a rate of 0.007% of devices distributed worldwide. Medtronic is assessing the best approach to permanently resolve this issue. In the meantime, healthcare professionals are reminded to reassure patients implanted with the affected device of the rare occurrence of the issue, and to advise them to follow current recharge instructions, particularly the ‘charging efficiency’ and ‘battery charge level’ indicators on their rechargers. 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.