Important Medical Device Information

Boston Scientific has issued an advisory regarding an issue with their pacemakers where the minute ventilation (MV) sensor signal can be oversensed, leading to inhibition of pacing and potential injury in pacemaker-dependent patients.

The issue affects certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems, particularly when used with Medtronic or Abbott pacing leads.

Recommendations

Until a software update is available, Boston Scientific recommends turning the MV sensor “OFF” for pacemaker-dependent patients and evaluating the risks and benefits of MV sensor use for other patients.

Additionally, patients should be periodically reassessed for pacemaker dependence, and non-invasive programming options should be explored if issues arise.

Manual:

Download: Boston Scientific Pacemaker User Manual

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