Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930); Impaired Healing (2378)
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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 an infection.It was further reported the patient noted oozing on bandage and the incision site was open.The icm was removed.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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