Model Number CI-1400-01 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Failure of Implant (1924); Undesired Nerve Stimulation (1980); Pain (1994); Dizziness (2194)
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Event Date 10/05/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing facial nerve simulation with device use.The recipient is presenting with pain and dizziness.A ct scan confirmed correct device position.Device could not be completed due to facial nerve stimulation and pain.Revision surgery is under consideration.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient is experiencing pain at the implant site following surgery and was recommended to use tylenol.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 device activation went well and issues have resolved.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 explanted device will not return for analysis.A review of the device history record was completed and no anomalies were noted.No further details will be provided.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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