Model Number CI-1600-04 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/05/2024 |
Event Type
malfunction
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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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Event Description
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The recipient reportedly experienced decreased performance.A review of the recipient's test data indicated impedance issues.Programming adjustments have been made; however, the issue did not resolve.The recipient's device was explanted.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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