Model Number CI-1600-05 |
Device Problems
Mechanical Problem (1384); Migration or Expulsion of Device (1395); Therapeutic or Diagnostic Output Failure (3023); Migration (4003)
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Patient Problem
Ossification (1428)
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Event Date 04/24/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing electrode migration.During initial implant surgery, the electrode was partially inserted due to ossification.The recipient is presenting with sound issues.Programming adjustments were made, however, the issue did not resolve.A ct scan confirmed electrode migration.Explant surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient will not be re-implanted due to ossification.The recipient has recovered well from surgery.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.The external visual inspection revealed the array 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 device passed some of the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.However, this device had an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra device is no longer distributed.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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