Model Number CI-1500-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problems
Skin Erosion (2075); Tissue Breakdown (2681)
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Event Date 05/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Na.
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Event Description
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The recipient reportedly experienced device extrusion.The recipient presented with skin flap breakdown, and is receiving treatment in the hospital.The recipient's device was explanted.
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Manufacturer Narrative
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A review of the device history record was completed 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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The recipient was reportedly given a topical recombinant human alkaline fibroblast growth factor.The infection and flap issues healed after explant surgery.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 the electrode was severed.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.This device passed all of 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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