Urgent Field Safety Notice
Boston Scientific has issued a software update to address the potential for pacing inhibition due to minute ventilation (MV) sensor signal oversensing in certain pacemaker and cardiac resynchronization therapy pacemaker systems.
The software update adds the Signal Artifact Monitor (SAM) to the proprietary suite of Safety Architecture diagnostics, which continuously monitors electrograms for MV sensor signal artifacts and measures MV vector lead impedance values.
If artifacts are detected or the MV vector lead impedance is out of range, the SAM either switches to the right ventricular vector or disables the MV sensor in approximately one second, eliminating the clinical risk of pacing inhibition associated with MV sensor signal oversensing.
Affected Devices
The software update supports the following pacemaker families: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, FORMIO, VITALIO, INGENIO, and ADVANTIO; and VISIONIST, VALITUDE, INTUA, and INVIVE family of CRT-Ps.
Manual:
Download: Boston Scientific Software Update for MV Sensor Oversensing
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