Model Number CI-1500-04 |
Device Problems
Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Insufficient Information (4580)
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Event Date 11/04/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing an incorrect device placement.A ct scan revealed the electrode outside of the cochlea.Revision surgery will be scheduled.
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Manufacturer Narrative
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On (b)(6), 2020, repositioning surgery was attempted, however, was not possible due to ossification.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's device was reportedly explanted.The recipient was re-implanted on the contralateral side 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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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.External visual inspection revealed sliced silicone overmold on the fantail region.This is believed to have occurred during revision surgery.Photographic imaging inspection confirmed severed electrode wires.This is believed to have occurred during revision surgery.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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