Model Number CI-1500-01 |
Device Problems
Intermittent Continuity (1121); Structural Problem (2506)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/17/2019 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced open circuits and intermittencies.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Programming adjustments were made, however, the issue did not resolve.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 silicone slices on the top cover near the electrode ground ring and along the lead.In addition, the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the array.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode revealed tensile breaks along the lead near the array at some electrodes.The photographic imaging inspection and scanning electron microscopy analysis revealed broken electrode wires along the lead near the array.It is believed that these breaks caused the open impedances measured at the clinic.Advanced bionics will continue to monitor failure modes of this type.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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