Model Number CI-1601-05 |
Device Problem
Migration (4003)
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Patient Problems
Fall (1848); Head Injury (1879)
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Event Date 08/01/2023 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced a fall with head trauma.The recipient was prescribed antibiotics (type unknown) prophylactically.The recipient is also experiencing electrode migration.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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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 recipient was successfully activated.The explanted device was reportedly discarded and will not return to advanced bionics for analysis.A review of the device history record was completed and no anomalies were noted.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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