Model Number LNQ11 |
Device Problem
Under-Sensing (1661)
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Patient Problem
Hematoma (1884)
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Event Date 02/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that the patient had a small hematoma after implant of the implantable cardiac monitor (icm).Additionally, the patient's icm also had undersensing.The icm showed several episodes with asystole and the patient never had a syncope.The device was reprogrammed and 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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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