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
malfunction
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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 user is suddenly not hearing anymore since september 2020.
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Event Description
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The user is suddenly not hearing anymore since (b)(6) 2020.Revision surgery is considered however, no date has been scheduled yet.
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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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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 user was suddenly no longer able to hear with the device since (b)(6) 2020.The user was reimplanted on (b)(6) 2022.
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Search Alerts/Recalls
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