BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U228 |
Device Problem
Under-Sensing (1661)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that during electrogram (egm) review of this cardiac resynchronization therapy pacemaker (crt-p), atrial undersensing was identified.This crt-p remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Search Alerts/Recalls
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