Model Number CI-1601-04 |
Device Problem
Migration (4003)
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Patient Problem
Head Injury (1879)
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Event Date 01/11/2024 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device migration as a result of a head trauma incident.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient was successfully activated after revision surgery.
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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 the electrode was severed and silicone damage was observed on the top and bottom covers of the device.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed a broken antenna coil wires.This is believed to have occurred during revision surgery.System lock was lost while manipulating the antenna.This is due to the antenna condition.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.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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Manufacturer Narrative
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Interim report was requested by the nca: the explanted device is undergoing analysis.The external visual inspection revealed the electrode was severed and silicone damage was observed on the top and bottom cover of the device.This is believed to have occurred during revision surgery.The photographic imaging inspection in pending.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed some the electrical tests performed.The residual gas analysis test is pending.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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