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
Impaired Healing (2378); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/15/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced wound healing issues and device extrusion.During the explant procedure of the device, it was reported that the electrode array remained in place and will be removed at a later date.The recipient will be reimplanted at a later date.
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Manufacturer Narrative
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The recipient was reimplanted on (b)(6) 2022 with another advanced bionics cochlear device.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 device was reportedly discarded and will not return to advanced bionics for analysis.A review of the device history record was completed and no anomalies were noted.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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