Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problems
Ossification (1428); Therapeutic Response, Decreased (2271)
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Event Date 02/22/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing impedance issues and decreased performance.The recipient presents with ossification in the ear.Programming adjustments were made, however, the issue did not resolve.Revision surgery is being considered.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was re-implanted 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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The external visual inspection revealed the array was severed near the array prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.Advanced electrical testing performed on the device showed lower than typical range on some of the electrodes.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra is no longer distributed.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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