Model Number CI-1400-01 |
Device Problem
Device Slipped (1584)
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Patient Problem
Hearing Impairment (1881)
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Event Date 11/13/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Udi number: na.
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Event Description
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The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue was not resolved.Revision surgery is under consideration.
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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.
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Manufacturer Narrative
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The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock 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.The internal visual inspection noted silver migration around 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 has been implemented.Feedthru assemblies from this vendor are no longer used.
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Search Alerts/Recalls
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