Model Number 638RL30 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Information (3190)
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Event Date 07/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 30mm annuloplasty ring, the ring was explanted and replaced with a 32mm ring due to a sizing error.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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