Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/02/2023 |
Event Type
Injury
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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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Event Description
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The recipient is reportedly experiencing dizziness, headaches and forgetfulness.The symptoms are not believed to be device related.The recipient has a medical history of seizures, eye cancer, and a gene mutation, which makes the recipient susceptible to tumor growth.The recipient is reportedly electing device explant due to the need for serial mris over time.Revision surgery has been 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.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 recipient was not reimplanted.The recipient has healed.The external visual inspection revealed the electrode was sliced.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed broken electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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