Model Number CI522 |
Device Problem
Expulsion (2933)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on february 27, 2024.
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Event Description
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Per the clinic, the patient electrodes were pushed out from the round window, subsequently the patient underwent revision surgery to reinsert the electrodes into the cochlea, however, the issue did not resolve.The device was explanted on (b)(6) 2024.The patient was re-implanted with another cochlear device during the same surgery.
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Manufacturer Narrative
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Device analysis report attached.Per the clinic, the patient was placed under general anesthesia on (b)(6) 2024.This report is submitted on april 2, 2024.
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Search Alerts/Recalls
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