Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Erythema (1840); Swelling (2091)
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Event Date 01/14/2020 |
Event Type
Injury
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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 implantable cardiac monitor (icm) was sticking through the skin.It was further reported that there was swelling and redness around the implant site.The icm was explanted.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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Search Alerts/Recalls
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