Model Number CI-1500-04 |
Device Problems
Mechanical Problem (1384); Failure of Device to Self-Test (2937); Intermittent Communication Failure (4038)
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Patient Problem
Fall (1848)
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Event Date 11/22/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock after a fall.Device testing could not be completed due to no lock.Revision surgery will be scheduled.
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Manufacturer Narrative
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Additional information: sections b.3, d.6b, & e.1.The recipient's device was reportedly explanted.The recipient has recovered well.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 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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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 that the electrode was severed.Slices in the silicone were also observed on the top cover.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken antenna wires.System lock could not be obtained at any spacing.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device had broken antenna coil wires.A corrective action was implemented.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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