Model Number CI-1500-02H |
Device Problems
Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)
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Patient Problem
No Information (3190)
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Event Date 09/26/2019 |
Event Type
malfunction
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Event Description
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The recipient is experiencing intermittent lock.External equipment was exchanged and programming adjustments were made, however the issue did not resolve.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed near the array, and a surgical tool mark was observed on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at a certain spacing with a sound processor.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The internal visual inspection revealed encroachment of non-conductive epoxy on an electrical component (kovar tab).The reported complaint of no lock was confirmed during the analysis of this device.Elevated resistance was measured across an electrical component (kovar tab), which is believed to be related to the loss of lock.A corrective action was implemented.This is the final report.
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Manufacturer Narrative
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The external visual inspection revealed that the electrode was severed near the array, and a surgical tool mark was observed on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at certain spacing with a sound processor.The electrode condition prevented some of the electrical tests performed.The device passed some of the electrical and mechanical tests performed.This is an interim report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Manufacturer Narrative
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The external visual inspection revealed that the electrode was severed near the array, and a surgical tool mark was observed on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at a certain spacing with a sound processor.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.This is an interim report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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