|
Model Number 500FA25 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problems
Non specific EKG/ECG Changes (1817); Swelling/ Edema (4577)
|
Event Date 04/18/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Medtronic received information that during the implant of this 25mm mechanical valve, it was explanted and replaced with an unknown product.The reason for the replacement was reported as ventricular fibrillation (v-fib, vf) and "the heart swelled".No additionaladverse patient effects were reported.
|
|
Event Description
|
Medtronic received additional information which clarified that heart distension occurred and from the inside out, the pressure expanded.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Updated b5 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.
|
|
Search Alerts/Recalls
|
|
|