Model Number CI24RE (CA) |
Device Problems
Expulsion (2933); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 08/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on august 25, 2020.
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Event Description
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Per the clinic, the patient underwent surgery for debridement and explantation of the device on (b)(6) 2020.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.
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Manufacturer Narrative
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It was reported that the patient experienced infection prior to explant.This report is submitted on 15 september 2020.
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Manufacturer Narrative
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Per the clinic, the patient had an extrusion (not specified what had extruded and where it had extruded to).This report is submitted on november 9, 2020.
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Search Alerts/Recalls
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