Model Number LNQ11 |
Device Problems
Over-Sensing (1438); Invalid Sensing (2293)
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Patient Problem
Syncope (1610)
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Event Date 10/12/2016 |
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) oversensed p-waves and was unable to detect third degree heart block.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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