Model Number MI1200 SYNCHRONY PIN |
Device Problems
Device Appears to Trigger Rejection (1524); Migration (4003)
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Patient Problems
Failure of Implant (1924); No Information (3190)
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Event Date 08/18/2020 |
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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There was an extrusion of the electrode out of the cochlea.The user will be explanted on the (b)(6).
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Manufacturer Narrative
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Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the patient report the active electrode migrated postoperatively completely outside of the cochlea.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
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Event Description
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Migration of the electrode out of the cochlea was observed.The concerned device was explantation on (b)(6) 2020.The recipient received a device from another manufacturer on the same day.
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Search Alerts/Recalls
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