Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Facial Nerve Paralysis (1846); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Discomfort (2330)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing non-auditory sensations, facial nerve stimulation, and discomfort.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient reportedly experienced an electrostatic discharge (esd) event a year ago.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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The recipient's activation reportedly went well.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 device passed external visual inspection.The device passed the photographic imaging inspection.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to a short from a power node to the case ground at the analog chip.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on case ground node inside the analog integrated circuit.This ultimately caused the device to cease functioning normally.A corrective action was implemented.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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