Model Number CI612 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Bacterial Infection (1735)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on 21 august 2020.
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Event Description
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Per the clinic, the patient experienced infection at implant site and subsequently was treated with iv and oral antibiotics unsuccessfully.There are plans to explant the device however this has not taken place as of the date of this report.
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Manufacturer Narrative
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It was reported that the device was explanted on (b)(6) 2020, re-implantation is planned but has not taken place as of the date of this report.This report is submitted on 10 september 2020.
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Event Description
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It was reported that the device was explanted on (b)(6) 2020, re-implantation is planned but has not taken place as of the date of this report.
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Search Alerts/Recalls
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