Model Number LNQ11 |
Device Problem
Over-Sensing (1438)
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Patient Problem
Syncope (1610)
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Event Date 01/16/2018 |
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 patient experienced syncope and that the implantable cardiac monitor (icm) experienced possible oversensing on bradycardia and pause episodes.The device remains in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The device is no longer in use.
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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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