Summary
Boston Scientific has issued an urgent field safety notice regarding intermittent oversensing of the Minute Ventilation (MV) sensor signal in certain pacemaker and cardiac resynchronization therapy pacemaker systems.
This issue may cause pre-syncope or syncope due to periods of pacing inhibition. The MV sensor signal oversensing is more likely to occur with affected Boston Scientific pacemakers using Medtronic or Abbott/St Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Recommendations
Boston Scientific recommends managing the risk for patients implanted with affected pacemaker systems by turning the MV sensor “OFF” or evaluating the risks of oversensing the MV sensor signal against the benefits of MV sensor indicated pacing.
Additionally, the company advises periodically re-assessing for pacemaker dependence and enrolling and following patients using the LATITUDE NXT Remote Patient Management System.
Manual:
Chat: Powered By VoiceSphere