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 Date 04/15/2021 |
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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Reportedly, the user stopped hearing with the implant on (b)(6) 2021.
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Manufacturer Narrative
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Additional information: according to currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However, a device investigation is necessary to determine a root cause.Re-implantation is considered but no date has been scheduled yet.
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Event Description
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Reportedly, the user suddenly stopped hearing with the implant on (b)(6) 2021.Re-implantation has been recommended.However, no date has been scheduled yet.
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Search Alerts/Recalls
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