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 01/30/2024 |
Event Type
malfunction
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Event Description
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Per the clinic the device was explanted on (b)(6) 2024, due to performance decrement.The patient was re-implanted with another cochlear device during the same surgery.
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Manufacturer Narrative
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This report is submitted on february 26, 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 may 20, 2024.
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Search Alerts/Recalls
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