Model Number MI1210 SYNCHRONY ST |
Device Problem
Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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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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In situ testing shows 2 affected channels; hearing performance with the device is not affected.
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Event Description
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In situ testing showed affected channels.Initially hearing performance with the device was not affected however, with time a decrease was observed.Reimplantation was performed on (b)(6) 2021.
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Manufacturer Narrative
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Conclusion: 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.Further the most basal channel was left outside of cochlea at implantation surgery.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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