Model Number 620BG33 |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Mitral Regurgitation (1964); No Information (3190); No Code Available (3191)
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Event Date 07/02/2018 |
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 post implant of this mitral annuloplasty band, the band was explanted and replaced with an unknown device.The reason for the replacement was not reported.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information that this band was replaced with a non-medtronic valve due to moderate regurgitation.If information is provided in the future, a supplemental report will be issued.
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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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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