Model Number CI-1500-04 |
Device Problems
Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/17/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced loss of lock.External equipment was exchanged, however, the issue was not resolved.The recipient reportedly falls on the implant side frequently due to vestibular areflexia.Revision surgery is scheduled.
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Manufacturer Narrative
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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 recipient's device was explanted.The recipient was re-implanted with another advanced bionics cochlear device.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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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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage to the top cover.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed broken antenna wires.System lock was lost while manipulating the antenna.The device passed the electrical tests performed.The device passed the mechanical test performed.This device had an open antenna.Advance bionics will continue to monitor failure modes of this type.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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