Model Number CI-1601-05 |
Device Problems
Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Head Injury (1879); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/29/2023 |
Event Type
Injury
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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 following a fall with head trauma.Programing adjustments were made; however, the issue did not resolve.Revision surgery has been scheduled.
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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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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 array was severed and silicone damage was observed on the top cover of the device.This is believed to have occurred during revision surgery.In addition, a broken electrode wire was observed below the electrode ground ring.The photographic imaging inspection revealed broken electrode wires below the electrode ground ring.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The scanning electron microscopy (sem) analysis revealed tensile breaks of some electrodes below the electrode ground ring.The device passed the mechanical test performed.The scanning electron microscopy (sem) analysis revealed broken electrode wires below the electrode ground ring which are believed to have been induced by the trauma reported.It is believed that these breaks caused the open impedances measured at the clinic.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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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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