Model Number AB-5100H-12 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384); Intermittent Communication Failure (4038)
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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 10/21/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock.Device testing was attempted, however, lock could not be achieved.Revision surgery is being considered.
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Manufacturer Narrative
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Additional information: section b.6.External equipment was exchanged, however, the issue did not resolve.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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Manufacturer Narrative
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Additional information: sections b.3, d.6b.The recipient's device was 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.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 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 test 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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