Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Cardiac Resynchronization Therapy pacemakers (CRT-Ps).
The affected CRT devices are identified as the following:-
The manufacturer has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with its certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for the affected pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
According to the manufacturer, its pacemakers can be used for RightRate (rate adaptive pacing), Respiratory Rate Trend, or AP Scan. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels.
The manufacturer is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 December 2017