Model Number C40+ |
Device Problem
Circuit Failure (1089)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/10/2024 |
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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Since (b)(6) 2023 the user heard constant static, buzzing, cracking and popping sounds.
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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.Additionally, about 12 years ago the user had an accident and reported that after that he perceives the coil placement has moved.A ct scan is considered but no date has been scheduled yet.
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Event Description
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Since mid of (b)(6) 2023 the user heard constant static, buzzing, cracking and popping sounds.
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Search Alerts/Recalls
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