Model Number CI-1400-02H |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 12/18/2018 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing intermittent lock and sounds quality issues.External equipment was exchanged and programming adjustments were made, however, only the issues did not resolve.The recipient presented with facial nerve stimulation.Revision surgery will be scheduled.
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Event Description
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The recipient is reportedly experiencing intermittent lock and sounds quality issues.External equipment was exchanged and programming adjustments were made, however, the issues did not resolve.The recipient presented with facial nerve stimulation.Revision surgery will be scheduled.
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Manufacturer Narrative
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Revision surgery is scheduled.
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Manufacturer Narrative
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The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.This is an interim report.
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Manufacturer Narrative
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The recipient's activation reportedly went well.
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Manufacturer Narrative
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The recipient device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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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 cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.Silver migration was noted across some electrical components.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies from this vendor are no longer used.This is the final report.
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Search Alerts/Recalls
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