Model Number CI-1600-04 |
Device Problems
Malposition of Device (2616); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Head Injury (1879); Insufficient Information (4580)
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Event Date 09/08/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced impedance issues due to incorrect electrode position.The recipient's device was explanted.The recipient was reimplanted with another cochlear device.
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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 silicone damage on the top and bottom covers, slices along the lead and the electrode was severed prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires along the lead.These are believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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 silicone damage on the top and bottom covers, slices along the lead, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires along the lead.These are believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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