Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hearing Impairment (1881); Undesired Nerve Stimulation (1980); Pain (1994)
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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 patient is reportedly experiencing non auditory sensations.The recipient was prescribed baclofen.External equipment was exchanged and programming adjustments were made.The recipient will continue to be monitored.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient additionally experienced pain with non auditory sensations.The recipient discontinued the medication prescribed and the issues have resolved.The recipient continues to use the device and will be managed per center protocol.Additional treatment details will not 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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