Model Number MI1250 SYNCHRONY 2 |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/26/2024 |
Event Type
malfunction
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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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The user's hearing performance with the device is affected after a head trauma occurred in (b)(6) 2023.Reportedly, in situ measurements have shown increased impedances.Latest expert measurements still show high impedances.Further medical intervention is currently unknown.
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Search Alerts/Recalls
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