Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Head Injury (1879); Nausea (1970); Fluid Discharge (2686)
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Event Date 07/22/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced leakage from the implant site and nausea following a head trauma.The recipient also experienced a fever, however, all the symptoms subsided within a few days.The recipient was given antibiotics (type unknown).The recipient's device had been activated and was able to use the device at the time of the head trauma.The implant site looks within normal limits.
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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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Advanced bionics considers the investigation into this reportable event as closed.The recipient's issue has reportedly resolved.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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