Model Number CI532 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Necrosis (1971)
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Event Date 11/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on november 8, 2022.
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Event Description
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Per the clinic, the patient experienced necrosis.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.
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Manufacturer Narrative
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Per the clinic, the device was explanted on (b)(6) 2022, and the patient was re-implanted with another cochlear device during the same surgery.This report is submitted on december 23, 2022.
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Search Alerts/Recalls
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