Model Number CI-1500-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problems
Unspecified Infection (1930); Tissue Breakdown (2681); Skin Infection (4544)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced an infection at the skin flap starting in (b)(6) 2020.The recipient was treated with antibiotics, however, the skin began to breakdown and the device became extruded.The recipient's device was explanted.The recipient was not reimplanted.The infection has resolved.
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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.Additional treatment details will not be provided.The external visual inspection revealed the electrode was severed 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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