Model Number 900SFC |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 08/28/2017 |
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 this tricuspid annuloplasty ring was "wasted and removed" on the day of implant.The reason for the explant is unknown.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information received indicated that the patient's device was impinging the native tissue.The device was explanted and replaced.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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