Model Number CI-1500-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 09/22/2023 |
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 facial nerve stimulation (fns) with device use following a head trauma event.Revision surgery is under consideration.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Device testing revealed abnormal results.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.A review of the device history record was performed at the request of the nca and no anomalies were noted.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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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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