Model Number CI24RE (CA) |
Device Problem
Expulsion (2933)
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Patient Problems
Head Injury (1879); Unspecified Infection (1930); Necrosis (1971); Seroma (2069); Tissue Breakdown (2681)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on april 13, 2022.
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Event Description
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Per the clinic, the patient developed a seroma subsequent to sustaining a head trauma (specific date not reported) and was treated with antibiotics (type, specific date and duration not reported).The patient then sustained another head trauma (specific date not reported), exposing the receiver/stimulator.Explant is planned but has not taken place at the time 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 patient experienced an infection and muscle necrosis at the implant site (specific date not reported).Subsequently, the patient was treated with steroid and iv antibiotics (specific date and duration not reported) however, the symptoms did not resolve.The device was explanted (specific date not reported).Reimplantation is planned but had not taken place at the time of this report.This report is submitted on may 18, 2022.
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Manufacturer Narrative
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Device analysis report is attached.This report is submitted on july 09, 2022.
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Search Alerts/Recalls
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