Model Number C40+ |
Device Problem
Circuit Failure (1089)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/30/2024 |
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 should 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 user's hearing performance with the device is affected.
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Manufacturer Narrative
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Additional information: according to the complaint information and the manufacturer_s experience with this kind of device, it is assumed that the device might have failed due to humidity ingress at the housing braze joint through micro-leaks.However, to determine an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
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Event Description
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The user's hearing performance with the device is affected.
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Search Alerts/Recalls
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