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 09/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is submitted on december 07, 2023.
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Event Description
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Per the clinic, the patient experienced poor performance and short circuits were noted on multiple electrodes.Subsequently, the device was explanted on (b)(6) 2023 and the patient was reimplanted with another cochlear device during the same surgery.
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Manufacturer Narrative
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Device analysis indicated device failure.Device analysis report attached.This report is submitted on january 09, 2024.
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Search Alerts/Recalls
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