Model Number CI22M |
Device Problem
Output Problem (3005)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/19/2023 |
Event Type
malfunction
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Event Description
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Per the clinic, the patient experienced a performance decrement with the device.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 february 19, 2024.
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Manufacturer Narrative
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Device analysis indicated device failure.Device analysis report is attached.This report is submitted on march 07, 2024.
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Search Alerts/Recalls
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