Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Erythema (1840); Pain (1994); Impaired Healing (2378)
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Event Date 10/11/2019 |
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) incision site did not look like it had healed at all.The incision site was open and reddened.The patient experienced pain at the site.It was further reported that implantable cardiac monitor (icm) experienced erosion and was protruding from the skin.The icm was explanted, and the patient received antibiotics prophylactically.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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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.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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