Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endocarditis (1834); Unspecified Infection (1930)
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Event Date 05/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.
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Event Description
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It was reported that the implantable loop recorder (ilr) was explanted due to infection.Subsequently, the patient developed endocarditis of the aortic valve.The prosthetic aortic valve was explanted and replaced.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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