Model Number 700FC |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/15/2016 |
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.A good faith effort will be made to obtain the applicable information relevant to the report.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 annuloplasty band, this device was explanted and replaced with a larger annuloplasty band because the physician felt the band was too small for the patient.No other adverse patient effects were reported.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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