Model Number MI1000 MED-EL CONCERT |
Device Problems
Output Problem (3005); Migration (4003)
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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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Affected channels have been observed during in situ testing.The user has an abnormal skin growth behind the pinna above the electrode lead and located on the pinna.
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Manufacturer Narrative
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Additional information: according to the received information from the field, the active electrode migrated partially out of cochlea post-operatively.Additionally, two channels were already left outside of cochlea during implantation surgery.Reportedly only seven channels are currently available for stimulation.In addition, keloid growth behind the pinna was observed, which is likely due to device unrelated medical reasons.Surgical procedure is considered to manage the observed issues; however no date has been scheduled yet.
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Event Description
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The recipient has an abnormal skin growth behind the pinna above the electrode lead and located on the pinna.Affected channels have been observed during in situ testing.However, the hearing performance using the device seems not to be affected.It is planned to implant the contralateral side and if possible, in the same surgery to remove the skin growth and try to re-insert the electrode on the concerned side.But the date of surgery has not been scheduled yet.
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Search Alerts/Recalls
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