Model Number C40+ |
Device Problem
Circuit Failure (1089)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/26/2022 |
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 reported intermittent hearing performance with the device on (b)(6) 2022 and a couple of hours later the device stopped working completely.Re-implantation is considered.
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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 reported intermittent function in (b)(6) 2022; a couple of hours later the hearing with the affected device stopped completely.The user was reimplanted.
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Search Alerts/Recalls
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