Model Number CI-1601-04 |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/29/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device migration.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Additional information: section d.10 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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On (b)(6) 2020, the recipient reportedly underwent repositioning surgery.On (b)(6) 2020, the recipient's device was explanted.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 and bottom covers prior to receipt.These are 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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