Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930)
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Event Date 03/01/2020 |
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) patient experienced a pocket site infection.It was noted that the implant site exhibited redness and drainage and the icm came out of the pocket.The icm will be replaced.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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