Model Number MI1000 MED-EL CONCERT |
Device Problems
Device Appears to Trigger Rejection (1524); Insufficient Information (3190)
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Patient Problems
Tissue Damage (2104); Skin Tears (2516)
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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 electrode lead can be seen in the external auditory canal.
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Manufacturer Narrative
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Additional information: according to the received information, the active electrode lead extruded into the external ear canal affecting the user_s benefit from the device.It could be assumed that the device did not cause or contribute to this outcome provided that this occurred ca.8 years after implantation and that the device is intended to remain implanted, being a reinsertion considered.Additionally, a complete active electrode insertion at implantation could not be yet determined.The clinic will monitor the user.
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Event Description
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The electrode lead can be seen in the external auditory canal.Access to sound with the device before this incident was normal, but afterwards the user did not respond to sound.No accident or trauma is reported.The user has no cochlear abnormalities or any medical history which might cause tissue breakdown.Also, there was no allegation against the device.The user will be monitored.Re-insertion is considered.
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Search Alerts/Recalls
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