Model Number 638BL30 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); 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 06/11/2018 |
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 this 30mm mitral annuloplasty band was implanted and explanted during the same procedure as it did not fully repair the patients native valve.The device was successfully replaced with a mechanical valve.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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Manufacturer Narrative
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Corrected initial aware date to be (b)(4) 2018.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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