Model Number MI1210 SYNCHRONY ST |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/11/2024 |
Event Type
malfunction
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Event Description
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The user was playing and she suddenly told her mother that she doesn't hear anything.Re-implantation is considered.
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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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Manufacturer Narrative
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Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.
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Event Description
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The user was playing and she suddenly told her mother that she doesn't hear anything.The user showed good benefit before.
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Search Alerts/Recalls
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