Model Number LNQ11 |
Device Problem
Under-Sensing (1661)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.
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Event Description
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It was reported that the implantable cardiac monitor (icm) was detecting false bradycardia episodes due to undersensing of premature ventricular contractions.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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