Urgent Field Safety Notice: Pacemakers (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2), Cardiac Resynchronization Therapy pacemakers (VALITUDE, VISIONIST) – Technical programming information Minute Ventilation Sensor

Important Medical Device Information

Boston Scientific has issued an urgent field safety notice regarding pacemakers and cardiac resynchronization therapy pacemakers due to reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal.

This oversensing may cause pre-syncope or syncope due to periods of pacing inhibition, particularly when used with Medtronic or Abbott pacing leads.

Root Cause Investigation

The MV sensor signal oversensing is attributed to intermittent high impedance conditions in the lead or pacemaker-lead connection, which can alter the MV sensor signal and lead to oversensing.

Clinical Impact

The clinical impact of MV sensor signal oversensing includes inappropriate mode switches and pacing inhibition, which can lead to syncope and injury in pacemaker-dependent patients.

Boston Scientific recommends managing the risk by turning the MV sensor “OFF” for pacemaker-dependent patients and evaluating the risks and benefits for other patients.

A software update is being developed to automatically detect and resolve this issue, with submission to regulatory agencies anticipated in March 2018.

Manual:

Download: Urgent Field Safety Notice: Pacemakers (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2), Cardiac Resynchronization Therapy pacemakers (VALITUDE, VISIONIST) – Technical programming information Minute Ventilation Sensor

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