Model Number C40+ |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/10/2017 |
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 user was no longer able to hear with the device.Re-implantation is being considered.
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Manufacturer Narrative
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Additional information: as per 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 reportedly took place, but the device has not been received for investigation yet.
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Event Description
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The user was no longer able to hear with the device.The recipient was re-implanted.
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Search Alerts/Recalls
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