Model Number 638BL34 |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 07/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 immediately after implanting this annuloplasty band, the band was explanted and replaced with a bioprosthetic valve.The repair was not sufficient, therefore a full replacement was performed.No additional adverse patient effects were reported. .
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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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