Model Number CI512 |
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 03/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on april 29, 2024.
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Event Description
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Per the clinic, the patient experienced poor performance with the device since activation leading to non-use.The device was explanted on (b)(6) 2024, and there are no plans to re-implant the patient with a new device as of the date of this report.
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Manufacturer Narrative
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Device analysis indicated device failure.Device analysis report attached.This report is submitted on june 05, 2024.
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Search Alerts/Recalls
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