Model Number LNQ11 |
Device Problem
Over-Sensing (1438)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2016 |
Event Type
malfunction
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Event Description
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It was reported that the device had over detection of muscle noise and motion artifact that resulted in false atrial fibrillation (af).The device is still in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Furthermore, the device was intermittently oversensing on tachycardia episodes.
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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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