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 Date 04/19/2021 |
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 affected and has been reportedly decreasing since (b)(6) 2020.
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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.In addition one to two channels remained extra cochlea during implantation surgery.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 affected and has been reportedly decreasing since (b)(6) 2020.Surgical intervention is considered; however, no date has been scheduled yet.
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Event Description
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The hearing performance with the device was affected and has been reportedly decreasing since (b)(6) 2020.The user has been explanted on (b)(6) 2021.As per information receive from the explant report form, the active electrode array has been found partially migrated out of cochlea, with only two channels remaining inserted.
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Manufacturer Narrative
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Conclusions: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.In addition, one to two channels remained extra cochlea during implantation surgery.Furthermore, the electrode array migrated out of cochlea due to the reported ossification of the cochlea; during explantation surgery several channels were found extra-cochlea, which might have contributed to the electrode lead mobility as well.The problems given in the recipient report appear to match the damage found.This is a final report.
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Search Alerts/Recalls
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