Model Number CI512 |
Device Problem
Electrical Shorting (2926)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/15/2021 |
Event Type
malfunction
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Event Description
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Per the clinic, the patient experienced poor performance with the device.The device was explanted (b)(6) 2021, and the patient was reimplanted with another cochlear device during the same surgery.
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Manufacturer Narrative
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This report is submitted on december 06,2021.
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Manufacturer Narrative
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Device analysis has indicated device failure.Device analysis report attached.This report is submitted on march 10, 2022.
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Search Alerts/Recalls
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