Model Number C40+ |
Device Problems
Circuit Failure (1089); Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/26/2024 |
Event Type
malfunction
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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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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.There was a sudden loss of function along with a loud high-pitched noise.The user was 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.In addition, in situ measurements showed four channels involved in two short circuits due to undetermined reasons.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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