Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problems
Failure of Implant (1924); Undesired Nerve Stimulation (1980); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/07/2022 |
Event Type
malfunction
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Event Description
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The patient was reportedly experiencing facial nerve stimulation.A review of the test data indicates impedance issues.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
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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.The recipient's device activation was successful.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 overmold on the top cover.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed broken electrodes within the electrode pocket.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires ultra 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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Search Alerts/Recalls
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