Model Number CI-1601-04 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Headache (1880); Itching Sensation (1943); Pain (1994); Tinnitus (2103); Dizziness (2194); Skin Inflammation/ Irritation (4545)
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Event Date 10/21/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing pain, dizziness, headaches, and tinnitus with and without device use.The recipient is presenting with redness at the magnet site and itchiness at the implant scar.The recipient takes ibuprofen to manage pain.The recipient a poor performer due to inconsistent device use because of pain.Revision surgery is scheduled.
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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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The recipient's device was reportedly explanted.The recipient was re-implanted with another 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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Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly continues to experience tinnitus.Additional treatment details will not be provided.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 the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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