Model Number CI-1601-05 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problems
Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/25/2022 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.The recipient is reportedly experiencing headaches with device use.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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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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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 reimplanted 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 external visual inspection revealed tool damage to the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to an electrode short in the electrode pocket.An internal corrective has been 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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