Model Number CI-1500-04 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fluid Discharge (2686); Skin Infection (4544); Insufficient Information (4580)
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Event Date 08/21/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing device migration.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient reportedly began to experience a pseudomonas aeruginosa and mrsa infection prior to explant surgery.The recipient presented with ear drainage due to otitis media.The recipient's infection was unable to be controlled and the electrode continued to migrate.The recipient was treated from (b)(6) 2020.The recipient was given levofloxacin (lvfx) antibiotics.The recipient was was hospitalized from (b)(6) 2020.The recipient's infection reportedly resolved and the recipient recovered.The recipient will be reimplanted.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 on the top and bottom cover and that the electrode was severed prior to receipt.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 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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