Model Number MI1050 MED-EL CONCERT 2 |
Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/15/2023 |
Event Type
malfunction
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Event Description
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Reportedly, the patient's impedance was high and unstable.The parents do not want to re-implant their child.
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Event Description
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Reportedly, the patient's impedance was high and unstable.The parents do not want to re-implant their child.
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Manufacturer Narrative
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The date awareness was inadvertently set incorrectly.Correct awareness day is (b)(6)2024.
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Search Alerts/Recalls
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