Model Number CI-1600-04 |
Device Problem
Programming Issue (3014)
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Patient Problem
No Code Available (3191)
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Event Date 04/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The recipient is reportedly experiencing sound quality issues.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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(b)(4).The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The external visual inspection revealed the electrode 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 electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The device passed the electrical tests performed.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain details regarding treatment were unsuccessful.The recipient's pain has resolved.This is the final report.
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Manufacturer Narrative
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The recipient reportedly experienced pain at the implant site.The recipient's device was explanted.
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Manufacturer Narrative
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The recipient was reportedly not explanted.Revision surgery is scheduled.
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Search Alerts/Recalls
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