Model Number AB-5100L |
Device Problems
Electrical /Electronic Property Problem (1198); Misconnection (1399); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023); Intermittent Communication Failure (4038)
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Patient Problems
Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/10/2022 |
Event Type
malfunction
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Event Description
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The patient was reportedly experiencing no lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery is under consideration.
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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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The recipient's device was reportedly explanted.The recipient was reimplanted with another cochlear device.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 company was informed that the explanted device will not be returned to the company for analysis.A review of the device history record noted no anomalies.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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device failed the residual gas analysis test.It is believed that the failure of this ics device was caused by a loss of hermetic seal, which was concluded from the rga data.This ultimately caused the device to cease functioning.This older device configuration is no longer 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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