Model Number AB-5100H |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Operating System Version or Upgrade Problem (2997)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/04/2020 |
Event Type
malfunction
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Event Description
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The recipient reportedly elected revision surgery for a technology upgrade.The recipient refuses to wear the device.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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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 electrode 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 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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