Model Number CI-1601-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Facial Nerve Paralysis (1846); Unspecified Infection (1930); Skin Infection (4544)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing an infection at the implant site.The recipient started experiencing bell's palsy approximately two days post operation.It is unclear if the bell's palsy is related to the infection.The recipient is prescribed to infusion steroids.
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Manufacturer Narrative
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The recipient was reportedly given an infusion of antibiotics.On (b)(6) 2020, the recipient's wound was irrigated and continues to receive antibiotic infusions.The recipient ceased device use.The recipient's bell's palsy is resolving.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 bell's palsy reportedly resolved.The recipient received last iv antibiotics.The recipient is presenting with device migration.Revision surgery is 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 reportedly explanted.The recipient was not re-implanted.The external visual inspection revealed silicone damage on the top and bottom covers, a damaged electrode ground ring, and the electrode was severed along the lead prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical tests 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.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 was reimplanted with another advanced bionics cochlear device.The recipient's issues resolved.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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