Model Number 310C29 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Anemia (1706); Pleural Effusion (2010)
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Event Date 11/17/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that the same day post-operatively of this 29mm mitral bioprosthetic valve, severe anemia was present.A transfusion of 2 units of packed red blood cells (rbc) were administered.It was also reported that 9 days later, a moderate pleural effusion was discovered.An ultrasound guided thoracentesis was performed, and subsequently repeated one day later.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Corrected data: h.6: coding medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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