Model Number AB-5100H |
Device Problems
Electrical /Electronic Property Problem (1198); Misconnection (1399); 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 07/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient is reportedly experiencing loss of lock and no sound.Revision surgery is under consideration.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics 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 external visual inspection revealed the electrode array was severed prior to receipt.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 some of the electrical tests performed.The device failed the residual gas analysis test.It is believed that the failure of this implantable cochlear stimulator (ics) device was caused by a loss of hermetic seal, which was concluded from the residual gas analysis 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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Search Alerts/Recalls
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