Model Number AB-5100H |
Device Problems
No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
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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 11/18/2021 |
Event Type
malfunction
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Event Description
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The recipient's device was device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: section b.1, b.2, & h.1 additional information: section b.3 the recipient reportedly elected revision for a technology upgrade.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 electrode was severed.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 older configuration is not currently manufactured.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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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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Search Alerts/Recalls
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