Model Number MI1000 MED-EL CONCERT |
Device Problem
Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it is to 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 hearing performance is reportedly affected.
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Manufacturer Narrative
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Additional information: according to the available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
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Event Description
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The hearing performance with the device is reportedly affected.Further medical intervention is considered.
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Manufacturer Narrative
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Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were determined to be the root cause of device failure.The problems given in the recipient report appear to match the damage found.This is a final report.
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Event Description
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The hearing performance with the device is reportedly affected.The user was re-implanted.
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Search Alerts/Recalls
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