Model Number MI1000 MED-EL CONCERT |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/17/2015 |
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 patient started to refuse the device 5 months ago for no clear reason.Latest in situ testing showed 9 channels with high impedance and 2 channels involved in a short circuit.Previous in situ testing showed normal results.And accident or trauma is unknown.
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Manufacturer Narrative
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Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The problems given in the patient report appear to match the damage found.This is a final report.
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Event Description
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The patient started to refuse the device 5 months ago for no clear reason.Latest in-situ testing showed 9 channels with high impedance and 2 channels involved in a short circuit.Previous in-situ testing showed normal results.No accident or trauma has been reported.
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Search Alerts/Recalls
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