Model Number CI-1400-01 |
Device Problems
Inaudible or Unclear Audible Prompt/Feedback (2283); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Undesired Nerve Stimulation (1980); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/25/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced poor performance and facial nerve stimulation.Programming adjustments were made, and the facial nerve stimulation improved, however, the recipient continued to experience sound quality issues.Revision surgery will be scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's issues have reportedly resolved and device activation was successful.The external visual inspection revealed the array was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the hires device is no longer distributed.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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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was reimplanted with another cochlear device.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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