Model Number CI622 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/01/2023 |
Event Type
Injury
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Event Description
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Per the clinic, the patient was placed under sedation on december 1, 2023, in order to perform advanced nrts and eabr.
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Manufacturer Narrative
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This report is submitted on december 27, 2023.
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Manufacturer Narrative
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Per the clinic, the patient experienced very little auditory reactions with device use.The device was explanted on (b)(6) 2024, and the patient was re-implanted with a new cochlear device during the same surgery.This report is submitted on march 25, 2024.
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Manufacturer Narrative
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Device analysis report attached.This report is submitted on may 06, 2024.
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Search Alerts/Recalls
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