Boston Scientific outlined the problem in a “Dear Doctor” letter in December 2017, warning about reports of a sensor glitch with some of its pacemakers and cardiac resynchronization systems.
The problem can occur with any of the company’s heart-pacing leads, but it is more likely to occur with pacemakers and other devices with cardiovascular leads in the right atrium or right ventricle of the heart.
In the worst case scenario, a defective sensor may slow down the patient’s heartbeat, leading to patients fainting or “syncope with associated injury in some pacemaker-dependent patients.”
Boston Scientific said it is working on a software update to detect and resolve the sensor problem. The company expects to submit the fix for regulatory approval in March and to release it in October, if approved.
Until then, the Minute Ventilation (MV) sensor should be turned off for pacemaker-dependent patients, or patients for whom the risks outweigh the benefits. The company also recommended enrolling pacemaker patients in its Latitude NXT remote monitoring program.