Model Number CI-1400-01 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Nausea (1970)
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Event Date 08/28/2018 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing device migration and nausea.Revision surgery is 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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Event Description
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The recipient is reportedly experiencing device and electrode migration as well as nausea.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient is reportedly doing well.
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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 revealed confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.
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Search Alerts/Recalls
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