Health Canada — Medical Devices · Canada · 2021-01-07 · Type II
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Reported risk: This update addresses a rare communication sequence during the first device interrogation with a Smartsync device manager that may result in the temporary suspension of some device features (i.e., battery measurements, capture management, atrial lead position check, effectivcrt algorithms, and adaptivcrt).This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
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