Extended charge time on St. Jude Medical Ellipse™ VR/DR Implantable Cardioverter Defibrillators (ICDs)

St Jude Medical (Singapore) Pte Ltd (‘St. Jude Medical’) would like to inform healthcare professionals of possible extended charge time as a result of internal damage to the capacitors used in the high voltage charging circuitry of Ellipse VR/DR Implantable Cardioverter Defibrillators (Ellipse ICDs). The anomaly is detectable via a vibratory patient alert and, for patients enrolled and actively followed, a Merlin.net notification and an alert message via the Merlin programmer upon interrogation. Healthcare professionals are recommended to schedule a follow up evaluation for their Ellipse ICD patients with the detected anomaly. Ellipse ICDs that have experienced repeated extended charge time out warnings should be considered for replacement. Affected stocks would also be replaced by St Jude Medical with redesigned devices. Healthcare professionals are advised to 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.