Model Number LNQ11 |
Device Problems
Signal Artifact/Noise (1036); Image Display Error/Artifact (1304); Over-Sensing (1438); Under-Sensing (1661)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardiac monitor (icm) experienced oversensing of artifact and t-wave oversensing (twos) during tachycardia episodes.It was further reported that the icm experienced undersensing during bradycardia episodes.The device remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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