Model Number AB-5100H-11A |
Device Problems
Migration or Expulsion of Device (1395); Expulsion (2933)
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Patient Problems
Bacterial Infection (1735); Failure of Implant (1924); Unspecified Infection (1930)
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Event Date 01/20/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device extrusion and otitis media.A ct scan confirmed electrode extrusion.The recipient's device was explanted.
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Manufacturer Narrative
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The recipient's infection reportedly resolved.The recipient will not be re-implanted.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 the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical test performed.This device was explanted for medical reasons.The device passed the tests performed.This older device configuration is no longer manufactured.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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