Model Number C40+ |
Device Problem
Circuit Failure (1089)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/12/2024 |
Event Type
malfunction
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Event Description
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The user's hearing performance with the device is affected since (b)(6) 2024.
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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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Manufacturer Narrative
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Additional information: in accordance with the information in the patient report and the manufacturers experience with this kind of device, it is assumed that it is possibly in an early stage of failure and is likely to fail sooner or later due to humidity ingress at the housing braze joint through micro-leaks.To determine an exact root cause a device investigation would be 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 since (b)(6) 2024.
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Event Description
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The user's hearing performance with the device is affected since (b)(6)2024.The user has been re-implanted.
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Manufacturer Narrative
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Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.Based on the manufacturer_s experience with this kind of devices, it can be assumed that the device has failed due to loss of hermeticity at the housing braze joint.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
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Search Alerts/Recalls
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