Model Number CI-1500-04 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Neuropathy (1983)
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Event Date 08/07/2018 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing poor performance secondary to auditory neuropathy.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 was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient reportedly had a fluid bubble under the surface of the implant.
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Manufacturer Narrative
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The device passed the external visual and photographic imaging inspections.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.
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Manufacturer Narrative
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The external visual inspection revealed delamination between the silastic overmold and a section of the bottom cover of the device.This created a void which was filled with fluid of undetermined origin, and had the appearance of a blister.Silastic overmolding serves only as a transition barrier between the titanium implant case and the tissue of the patient.It does not serve as an additional layer of sealing of the internal device and thus has no impact on hermeticity or the electrical functionality of the device.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.
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Search Alerts/Recalls
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