Model Number CI-1400-01 |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Undesired Nerve Stimulation (1980)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing inflammation and sound quality issues.Programming adjustments were made, however, the issue did not resolve.The recipient was prescribed steroids as the doctor believed the symptoms are inflammation related.The steroids showed no improvement.The recipient was recommended device non-use for 4 weeks.Revision surgery is under consideration.
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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 inflammation reportedly resolved.Revision surgery will be scheduled.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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Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced facial nerve stimulation prior to revision surgery.The external visual inspection revealed torn silicone on the top and bottom covers.In addition, the electrode 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 an 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 90k 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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Advanced bionics considers the investigation into this reportable event as closed.Additional treatment details will not be provided.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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Advanced bionics considers the investigation into this reportable event as closed.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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