Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/01/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced electrode migration and no response to stimulation.A ct scan revealed electrode contacts outside of the cochlea.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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The recipient's activation reportedly went well.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 sliced silicone to the overmold on the magnet pocket, the top cover and the fantail region, as well as a severed electrode.These anomalies are believed to have occurred during revision surgery.Photographic imaging inspection revealed damaged wires at the severed end of the electrode.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.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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