Model Number CI-1600-05 |
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 04/13/2024 |
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 is reportedly experiencing decreased performance.A review of the test data indicates impedance issues.Revision surgery is scheduled.
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Manufacturer Narrative
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Correction information: section a.2 additional information: sections b.3 & d.6b 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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Search Alerts/Recalls
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