Potential premature battery depletion in a subset of BIOTRONIK ICD and CRT-D devices

A Dear Healthcare Professional Letter has been issued by BIOTRONIK Asia Pacific Pte Ltd to inform healthcare professionals of an increased likelihood of premature battery depletion in a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to lithium plating in the battery. The interval between the elective replacement indicator (ERI) being triggered and the loss of ability to provide therapy may be shorter than expected in the affected devices, resulting in an earlier need for device exchange. No reports of serious injury or death associated to this issue have been received by BIOTRONIK. Healthcare professionals are advised not to implant any potentially affected devices and to continue with the standard patient follow-up schedule. If there is an unexpected ERI notification for affected devices, device replacement is recommended immediately for pacemaker dependent patients and within a week for patients that are not pacemaker dependent or patients with primary prevention ICD. Prophylactic replacement is not recommended as the risk of complications for ICD exchange outweighs the risk associated with this issue. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

22 Mar 2021

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.