Model Number MMT-5100R |
Device Problems
Application Program Version or Upgrade Problem (2881); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/30/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly elected revision surgery for a technology upgrade.The recipients device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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The recipient¿s device will not return to advanced bionics for analysis.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.A review of the device history record was completed and no anomalies were noted.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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