Model Number CI-1500-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced electrode extrusion.The recipient presents with purulent discharge.The recipient's device was explanted.The recipient was not reimplanted.
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Manufacturer Narrative
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The recipient's infection is reportedly not device related.The recipient experienced skin flap inflammation.The recipient is doing well.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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed torn silicone on the bottom cover and the magnet pocket, and cuts near the fantail region prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and 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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