Model Number CI-1400-01 |
Device Problems
Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)
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Patient Problem
Hearing Loss (1882)
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Event Date 10/22/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Event Description
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The recipient is reportedly experiencing intermittencies and loss of sound.External equipment was exchanged and programming adjustments were made, however, the issue was not resolved.Revision surgery will be 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.
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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 device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed several of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across one electrical component.This device had moisture that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis and dye penetrant data, it is believed that this device was non-hermetic, and that the root cause of the excessive moisture was a leak through the feedthru seals.A corrective action has been implemented.This is the final report.
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Search Alerts/Recalls
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