Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/08/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device migration.A ct scan confirmed device migration.The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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The recipient has reportedly healed well.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 silicone damage on the top cover 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 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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