Model Number MI1200 SYNCHRONY |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/08/2024 |
Event Type
malfunction
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Event Description
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The user's hearing performance with the device is affected after a trauma to the head.It was recommended to reimplant the user on the right side.No date has been scheduled yet.
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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 reported mechanical impact appears very likely.In addition in situ measurements showed 2 channels with hi impedance already before the reported impact due to undetermined reasons.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's hearing performance with the device is affected after a trauma to the head.Reimplantation is considered, but no date has been scheduled yet.
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Search Alerts/Recalls
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