Model Number CI-1500-04 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)
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Patient Problem
Headache (1880)
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Event Date 11/19/2019 |
Event Type
Injury
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Event Description
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The recipient reportedly elected explant surgery due to device non-use and migraines.The recipient's device was explanted.The recipient was not reimplanted.The recipient is doing well.
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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 that 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 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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