Model Number CI-1601-05 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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Patient Problems
Total Hearing Loss (4473); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/20/2022 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing no sound due to an incorrect electrode position.Activation was unable to be attained.A ct scan confirmed the incorrect electrode position.There was no difficulties with initial electrode insertion reported.Revision surgery will be scheduled.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: section d.4 additional information: section b.3 the recipient has reportedly healed well following revision surgery and the recipient's device was activated.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 reportedly underwent repositioning surgery, however the issues did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient reportedly has a anatomic abnormality in which the cochlea is not partitioned partially.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 cuts in the silicone overmold on the top cover, as well as a severed electrode.These anomalies are 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 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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