Model Number CI422 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on 17 february 2021.
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Event Description
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Per the clinic, the patient experienced extrusion of the device and subsequently underwent skin revision surgery (date not reported).The implanted device remains.
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Manufacturer Narrative
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Per the clinic, the patient experienced an infection and the device was explanted on (b)(6) 2021.The patient was re-implanted with a new device during the same surgery.This report is submitted on april 2, 2021.
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Manufacturer Narrative
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This report is submitted on may 3, 2021.
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Search Alerts/Recalls
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