Model Number 800SC36 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 07/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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No product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that this 36mm mitral annuloplasty band was implanted and explanted during the same procedure for unknown reasons.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information that the reason for immediate explant was that after fully suturing the band into place, it was determined to be too large.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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