Model Number C40+ |
Device Problem
Circuit Failure (1089)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been explanted and 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 was affected.The user was re-implanted on (b)(6) 2024.
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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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Event Description
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The user's hearing performance with the device was affected.The user was re-implanted on (b)(6) 2024.
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Search Alerts/Recalls
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