Model Number CI-1500-04 |
Device Problem
Intermittent Continuity (1121)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2019 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing intermittent lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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The device passed the external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed the electrical tests performed.This is an interim report.
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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 device passed the external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed the mechanical tests performed.The internal hybrid visual inspection revealed non-conductive epoxy encroachment on an electrical component.The reported complaint of no lock was confirmed during this analysis of this device.A significant drop in signal strength as well as elevated resistance was measured across an electrical component joint, 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 device passed the external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.This is an interim report.
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Search Alerts/Recalls
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