Model Number 900 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Jaundice (2187); Blood Loss (2597)
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Event Date 10/25/2015 |
Event Type
Injury
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Manufacturer Narrative
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Multiple attempts to obtain additional information have been unsuccessful.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).
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Event Description
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Medtronic received information from the patient's family member that, approximately three months post implant of this tricuspid bioprosthetic ring, the patient underwent surgery to either repair or replace the patient's tricuspid valve, as the tricuspid valve had two leaks.The family member reported that the patient had been "losing blood" and appeared jaundiced.The family member could not confirm whether the bioprosthetic ring was removed or whether any new device was implanted.
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Manufacturer Narrative
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Device manufacturing date has been added to this report.
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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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