Model Number MI1000 MED-EL CONCERT |
Device Problem
Migration (4003)
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Patient Problem
Discomfort (2330)
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Event Date 05/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been explanted and 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 asked for a fitting appointment because she feels discomfort with some sounds.The user has been re-implanted on (b)(6) 2023 with a shorter electrode array.
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Event Description
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The user asked for a fitting appointment because of discomfort associated with some sounds.The user has been re-implanted on (b)(6) 2023 with a shorter electrode array.
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Manufacturer Narrative
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Conclusions: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Based on the received information the recipient was explanted due to a migration of the active electrode out of cochlea.Reportedly also an incomplete insertion at the implantation surgery was achieved.Mechanical damages found during investigation are attributable to the removal surgery.This is a final report.
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Search Alerts/Recalls
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