Model Number CI-1500-04 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)
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Event Date 08/25/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced swelling and drainage.The recipient was treated with antibiotics.The recipient then presented with wound dehiscence and device extrusion.The recipient is being treated with additional medications.The recipient's device was explanted.The recipient will continue oral antibiotic, doxycycline, for 3 months.
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Manufacturer Narrative
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The recipient is reportedly healing well.Re-implantation is under consideration.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 that the electrode was severed.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.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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