Urgent medical device correction for InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042B, 8042U

Medtronic International Limited would like to inform healthcare professionals of an issue with InSync® III Cardiac Resynchronisation Therapy Pacemakers (CRT-P), models 8042, 8042B and 8042U, related to long-term battery performance. Medtronic has confirmed 30 devices (0.03%) worldwide have been impacted by this issue, for which the root cause is unexpected high battery impedance. Pacing function of the implant may be impacted as a result of the battery’s inability to supply sufficient electrical current. Patients may experience a return of heart failure symptoms, resulting in serious injury or death in pacemaker dependent patients. InSync® III CRT-P are no longer distributed, and healthcare professionals are advised to refer to the letter for recommendations regarding patients implanted with this device.

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.